2024/04/08 更新

写真a

マスダ ノリカズ
増田 慎三
MASUDA Norikazu
所属
大学院医学系研究科 総合医学専攻 病態外科学 特任教授
職名
特任教授
外部リンク

学位 1

  1. 医学博士 ( 2001年3月   大阪大学 ) 

研究キーワード 4

  1. 臨床試験

  2. 乳癌

  3. 乳癌

  4. 臨床試験

学歴 3

  1. 大阪大学   大学院医学系研究科

    1997年4月 - 2001年3月

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    国名: 日本国

  2. 大阪大学   大学院医学系研究科

    1997年4月 - 2001年3月

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    国名: 日本国

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  3. 大阪大学   大阪大学医学部

    1987年4月 - 1993年3月

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    国名: 日本国

 

論文 298

  1. Palbociclib as an early-line treatment for Japanese patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: a review of clinical trial and real-world data. 査読有り

    Masuda N, Kosaka N, Iwata H, Toi M

    International journal of clinical oncology   26 巻 ( 12 ) 頁: 2179 - 2193   2021年12月

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    担当区分:筆頭著者, 責任著者   記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1007/s10147-021-02013-8

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  2. Phase 1 trial of entinostat as monotherapy and combined with exemestane in Japanese patients with hormone receptor-positive advanced breast cancer 査読有り

    Masuda Norikazu, Tamura Kenji, Yasojima Hiroyuki, Shimomura Akihiko, Sawaki Masataka, Lee Min-Jung, Yuno Akira, Trepel Jane, Kimura Ryoko, Nishimura Yozo, Saji Shigehira, Iwata Hiroji

    BMC CANCER   21 巻 ( 1 ) 頁: 1269   2021年11月

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    担当区分:筆頭著者, 責任著者   記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:BMC Cancer  

    Background: Entinostat is an oral inhibitor of class I histone deacetylases intended for endocrine therapy-resistant patients with hormone receptor-positive (HR+) advanced or metastatic breast cancer (BC). We examined the safety, efficacy, and pharmacokinetics of entinostat monotherapy and combined entinostat/exemestane in Japanese patients. Methods: This phase 1 study (3 + 3 dose-escalation design) enrolled postmenopausal women with advanced/metastatic HR+ BC previously treated with nonsteroidal aromatase inhibitors. Dose-limiting toxicities (DLTs) of entinostat monotherapy (3 mg/qw, 5 mg/qw, or 10 mg/q2w) and entinostat+exemestane (5 mg/qw + 25 mg/qd) were assessed. Pharmacokinetics, lysine acetylation (Ac-K), and T-cell activation markers were measured at multiple time points. Results: Twelve patients were enrolled. No DLTs or grade 3–5 adverse events (AEs) occurred. Drug-related AEs (≥ 2 patients) during DLT observation were hypophosphatemia, nausea, and platelet count decreased. Six patients (50%) achieved stable disease (SD) for ≥ 6 months, including one treated for > 19 months. Median progression-free survival was 13.9 months (95% CI 1.9–not calculable); median overall survival was not reached. Area under the plasma concentration-time curve and Ac-K in peripheral blood CD19+ B cells increased dose-proportionally. The changing patterns of entinostat concentrations and Ac-K levels were well correlated. T-cell activation markers increased over time; CD69 increased more in patients with SD ≥ 6 months vs. SD < 6 months. Conclusions: Entinostat monotherapy and combined entinostat/exemestane were well tolerated in Japanese patients, with no additional safety concerns compared with previous reports. The correlation between pharmacokinetics and Ac-K in peripheral blood CD19+ B cells, and also T-cell activation markers, merits further investigation. Trial registration: JAPIC Clinical Trial Information, JapicCTI-153066. Registered 12 November 2015. ClinicalTrials.gov, NCT02623751. Registered 8 December 2015.

    DOI: 10.1186/s12885-021-08973-4

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  3. Capecitabine in Combination with Endocrine Therapy as Maintenance Therapy after Bevacizumab Plus Paclitaxel Induction Therapy for Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer: KBCSG-TR1214.

    Masuda N, Yoshinami T, Ikeda M, Mizutani M, Yamaguchi M, Komoike Y, Takashima T, Yoshidome K, Tsurutani J, Iwamoto M, Fujisawa F, Yasojima H, Yamamura J, Morishima H, Aki F, Yamada T, Morita S, Nakayama T

    Cancers   13 巻 ( 17 )   2021年8月

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    担当区分:筆頭著者, 責任著者   記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.3390/cancers13174399

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  4. Long-Term Outcomes of a Randomized Study of Neoadjuvant Induction Dual HER2 Blockade with Trastuzumab and Lapatinib Followed by Weekly Paclitaxel Plus Dual HER2 Blockade for HER2-Positive Primary Breast Cancer (Neo-Lath Study). 査読有り

    Tokunaga E, Masuda N, Yamamoto N, Iwata H, Bando H, Aruga T, Ohtani S, Fujisawa T, Takano T, Inoue K, Suganuma N, Takada M, Aogi K, Sakurai K, Shigematsu H, Kuroi K, Haga H, Ohno S, Morita S, Toi M

    Cancers   13 巻 ( 16 )   2021年8月

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    担当区分:責任著者   記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.3390/cancers13164008

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  5. Eribulin-based neoadjuvant chemotherapy for triple-negative breast cancer patients stratified by homologous recombination deficiency status: a multicenter randomized phase II clinical trial. 査読有り

    Masuda N, Bando H, Yamanaka T, Kadoya T, Takahashi M, Nagai SE, Ohtani S, Aruga T, Suzuki E, Kikawa Y, Yasojima H, Kasai H, Ishiguro H, Kawabata H, Morita S, Haga H, Kataoka TR, Uozumi R, Ohno S, Toi M

    Breast cancer research and treatment   188 巻 ( 1 ) 頁: 117 - 131   2021年7月

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    担当区分:筆頭著者, 責任著者   記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1007/s10549-021-06184-w

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  6. Impact of coronary bifurcation angle on stent malapposition in a randomized comparison between proximal optimization technique followed by side branch dilatation and kissing balloon inflation

    Yamawaki M, Murasato Y, Watanabe Y, Kinoshita Y, Okubo M, Yumoto K, Masuda N, Otake H, Aoki J, Nakazawa G, Numasawa Y, Ito T, Shite J, Okamura T, Takagi K, Kozuma K, Lefèvre T, Chevalier B, Louvard Y, Suzuki N, Kozuma K

    IJC Heart and Vasculature   48 巻   2023年10月

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    出版者・発行元:IJC Heart and Vasculature  

    Background: The impact of coronary bifurcation angle (BA) on incomplete stent apposition (ISA) after crossover stenting followed by side branch (SB) intervention has not been established. Methods: A total of 100 crossover stentings randomly treated with proximal optimization technique followed by short balloon dilation in the SB (POT-SBD group, 48 patients) and final kissing balloon technique (KBT group, 52 patients) were analyzed in the PROPOT trial. Major ISA with maximum distance > 400 μm and its location was determined using optical coherence tomography before SB intervention and at the final procedure. The BA was defined as the angle between the distal main vessel and SB. Optimal POT was determined when the difference in stent volume index between the proximal and distal bifurcation was greater than the median value (0.86 mm3/mm) before SB intervention. Result: Major ISA was more frequently observed in the POT-SBD than in the KBT group (35% versus 17%, p < 0.05). In the POT-SBD group, worsening ISA after SBD was prominent at the distal bifurcation. The BA was an independent predictor of major ISA (odds ratio 1.04, 95% confidence interval 1.00–1.07, p < 0.05) with a cut-off value of 59.5° (p < 0.05). However, the cases treated with optimal POT in the short BA (<60°) indicated the lowest incidence of major ISA. In the KBT group, BA had no significant impact. Conclusion: A wide BA has a potential risk for the occurrence of major ISA after POT followed by SBD in coronary bifurcation stenting.

    DOI: 10.1016/j.ijcha.2023.101265

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  7. Phase II trial of biweekly administration with eribulin after three cycles of induction therapy in hormone receptor-positive, HER2-negative metastatic breast cancer (JACCRO BC-03)

    Kobayashi Kokoro, Masuda Norikazu, Mizuno Toshiro, Miura Kayo, Tokuda Yutaka, Yoshinami Tetsuhiro, Kawaguchi Hidetoshi, Ohtani Shoichiro, Saeki Toshiaki, Toi Masakazu, Takeuchi Masahiro, Ito Yoshinori

    BREAST CANCER RESEARCH AND TREATMENT   201 巻 ( 3 ) 頁: 409 - 415   2023年10月

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    記述言語:英語   出版者・発行元:Breast Cancer Research and Treatment  

    Purpose: Metastatic breast cancer (MBC) is usually incurable; treatment aims to maximize patients’ function and quality of life (QOL). Eribulin is a standard treatment in patients with MBC pretreated with anthracycline and taxane; however, the best administration schedule is unknown. Methods: In this prospective phase II trial of patients with luminal MBC, we administered biweekly eribulin to patients who completed a three-cycle induction treatment. Results: Sixty patients with hormone-receptor-positive and HER2-negative MBC were enrolled; 40 obtained stable disease (SD) or better efficacy after induction therapy, after which they were switched to biweekly maintenance administration. The median progression-free survival (PFS) in patients who switched to maintenance therapy was 15.21 weeks (95% CI 9.71–22.14), starting on the first day of maintenance therapy. Overall survival (OS) in patients who switched to maintenance therapy was 21.39 months (95% CI 18.89–32.89). PFS and OS in the whole population starting from the registration date were 19.00 weeks (95% CI 17.00–25.00) and 21.52 months (95% CI 16.23–24.25), respectively. PFS from the enrollment date for patients who received maintenance therapy was 25.29 weeks (95% CI 19.14–32.14). Patients who achieved complete response or partial response during induction therapy had significantly longer PFS compared to patients with SD. Conclusion: The efficacy of biweekly administration of eribulin at maintenance was nonsignificant. However, less frequent visits are convenient, and reduced dose intensity improves safety. Biweekly administration, besides dose reduction, could be an acceptable option for patients who are unable to maintain a standard regimen.

    DOI: 10.1007/s10549-023-07030-x

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  8. A risk-based subgroup analysis of the effect of adjuvant S-1 in estrogen receptor-positive, HER2-negative early breast cancer

    Takada Masahiro, Imoto Shigeru, Ishida Takanori, Ito Yoshinori, Iwata Hiroji, Masuda Norikazu, Mukai Hirofumi, Saji Shigehira, Ikeda Takafumi, Haga Hironori, Saeki Toshiaki, Aogi Kenjiro, Sugie Tomoharu, Ueno Takayuki, Ohno Shinji, Ishiguro Hiroshi, Kanbayashi Chizuko, Miyamoto Takeshi, Hagiwara Yasuhiro, Toi Masakazu

    BREAST CANCER RESEARCH AND TREATMENT     2023年9月

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    記述言語:英語   出版者・発行元:Breast Cancer Research and Treatment  

    Purpose: The Phase III POTENT trial demonstrated the efficacy of adding S-1 to adjuvant endocrine therapy for estrogen receptor-positive, HER2-negative early breast cancer. We investigated the efficacy of S-1 across different recurrence risk subgroups. Methods: This was a post-hoc exploratory analysis of the POTENT trial. Patients in the endocrine-therapy-only arm were divided into three groups based on composite risk values calculated from multiple prognostic factors. The effects of S-1 were estimated using the Cox model in each risk group. The treatment effects of S-1 in patients meeting the eligibility criteria of the monarchE trial were also estimated. Results: A total of 1,897 patients were divided into three groups: group 1 (≤ lower quartile of the composite values) (N = 677), group 2 (interquartile range) (N = 767), and group 3 (> upper quartile) (N = 453). The addition of S-1 to endocrine therapy resulted in 49% (HR: 0.51, 95% CI: 0.33–0.78) and 29% (HR: 0.71, 95% CI 0.49–1.02) reductions in invasive disease-free survival (iDFS) events in groups 2 and 3, respectively. We could not identify any benefit from the addition of S-1 in group 1. The addition of S-1 showed an improvement in iDFS in patients with one to three positive nodes meeting the monarchE cohort 1 criteria (N = 290) (HR: 0.47, 95% CI: 0.29–0.74). Conclusions: The benefit of adding adjuvant S-1 was particularly marked in group 2. Further investigations are warranted to explore the optimal usage of adjuvant S-1.

    DOI: 10.1007/s10549-023-07099-4

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  9. Efficacy, safety, and biomarker analysis of nivolumab in combination with abemaciclib plus endocrine therapy in patients with HR-positive HER2-negative metastatic breast cancer: a phase II study (WJOG11418B NEWFLAME trial).

    Masuda J, Sakai H, Tsurutani J, Tanabe Y, Masuda N, Iwasa T, Takahashi M, Futamura M, Matsumoto K, Aogi K, Iwata H, Hosonaga M, Mukohara T, Yoshimura K, Imamura CK, Miura S, Yamochi T, Kawabata H, Yasojima H, Tomioka N, Yoshimura K, Takano T

    Journal for immunotherapy of cancer   11 巻 ( 9 )   2023年9月

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    記述言語:英語   出版者・発行元:Journal for immunotherapy of cancer  

    BACKGROUND: Hormone receptor (HR)-positive breast cancer is a disease for which no immune checkpoint inhibitors have shown promise as effective therapies. Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors synergistically increased the effectiveness of antiprogrammed cell death protein-1 (anti-PD-1)/programmed death-ligand 1 (PD-L1) antibodies in preclinical studies. METHODS: This non-randomized, multicohort, phase II study evaluated the efficacy and safety of the anti-PD-1 antibody nivolumab 240 mg administered every 2 weeks in combination with the CDK4/6 inhibitor abemaciclib 150 mg twice daily and either fulvestrant (FUL) or letrozole (LET) as a first-line or second-line treatment for HR-positive HER2-negative metastatic breast cancer. The primary end point was the objective response rate (ORR), and secondary end points were toxicity, progression-free survival, and overall survival. Blood, tissue, and fecal samples were collected at multiple points for correlative studies to evaluate immunity biomarkers. RESULTS: From June 2019 to early study termination due to safety concerns on July 2020, 17 patients were enrolled (FUL: n=12, LET: n=5). One patient with a prior treatment history in the FUL cohort was excluded. ORRs were 54.5% (6/11) and 40.0% (2/5) in the FUL and LET cohorts, respectively. Treatment-emergent (TE) adverse events (AEs) of grade ≥3 occurred in 11 (92%) and 5 (100%) patients in the FUL and LET cohorts, respectively. The most common grade ≥3 TEAEs were neutropenia (7 (58.3%) and 3 (60.0%) in the FUL and LET cohorts, respectively), followed by alanine aminotransferase elevation (5 (41.6%) and 4 (80.0%)). One treatment-related death from interstitial lung disease occurred in the LET cohort. Ten patients developed liver-related grade ≥3 AEs. Liver biopsy specimens from 3 patients showed hepatitis characterized by focal necrosis with predominant CD8+ lymphocyte infiltration. Marked elevation of tumor necrosis factor-related cytokines and interleukin-11, and a decrease in peripheral regulatory T cells (Tregs), were observed in patients with hepatotoxicity. These findings suggest that treatment-related toxicities were immune-related AEs likely caused by proinflammatory cytokine production and suppression of Treg proliferation due to the addition of abemaciclib to nivolumab therapy. CONCLUSIONS: Although the combination of nivolumab and abemaciclib was active, it caused severe and prolonged immune-related AEs. TRIAL REGISTRATION NUMBER: JapicCTI-194782, jRCT2080224706, UMIN000036970.

    DOI: 10.1136/jitc-2023-007126

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  10. Olaparib efficacy in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer: Subgroup analyses from the phase III OlympiAD trial

    Senkus Elzbieta, Delaloge Suzette, Domchek Susan M., Conte Pierfranco, Im Seock-Ah, Xu Binghe, Armstrong Anne, Masuda Norikazu, Fielding Anitra, Robson Mark, Tung Nadine

    INTERNATIONAL JOURNAL OF CANCER   153 巻 ( 4 ) 頁: 803 - 814   2023年8月

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    記述言語:英語   出版者・発行元:International Journal of Cancer  

    In the primary analysis of the phase III OlympiAD trial, olaparib significantly prolonged progression-free survival (PFS) vs chemotherapy treatment of physician's choice (TPC) in patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer (mBC). We report subgroup analyses for the final analysis at a median OS follow-up of 18.9 months (olaparib) and 15.5 months (TPC). Patients (N = 302) with gBRCAm, HER2-negative mBC and ≤2 previous lines of chemotherapy for mBC were randomized 2:1 to open-label olaparib (300 mg twice daily) or TPC. All subgroup analyses were prespecified except site of metastases. Investigator-assessed median PFS was 8.0 months (95% confidence interval [CI] 5.8-8.4; 176/205 events) for olaparib and 3.8 months (95% CI 2.8-4.2; 83/97 events) for TPC (hazard ratio 0.51, 95% CI 0.39-0.66). In subgroup analyses, median PFS hazard ratios (95% CI) favored olaparib: hormone receptor status (triple-negative: 0.47, 0.32-0.69; hormone receptor-positive: 0.52, 0.36-0.75); gBRCAm (BRCA1: 0.49, 0.35-0.71; BRCA2: 0.49, 0.33-0.74); site of metastases (visceral/CNS: 0.53, 0.40-0.71; non-visceral: 0.45, 0.23-0.98); prior chemotherapy for mBC (yes: 0.51, 0.38-0.70; no: 0.49, 0.30-0.82); prior platinum-based chemotherapy for BC (yes: 0.49, 0.30-0.83; no: 0.50, 0.37-0.69); progressive disease at randomization (yes: 0.48, 0.35-0.65; no: 0.61, 0.36-1.07). Investigator-assessed objective response rates were higher across all subgroups with olaparib (35-68%) vs TPC (5-40%). Global health status/health-related quality of life increased in all subgroups with olaparib vs decreased/no change with TPC. These data confirm the consistency of olaparib benefit across patient subgroups in OlympiAD.

    DOI: 10.1002/ijc.34525

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  11. Potential value of ctDNA monitoring in metastatic HR + /HER2-breast cancer: longitudinal ctDNA analysis in the phase Ib MONALEESASIA trial

    Chiu Joanne, Su Fei, Joshi Mukta, Masuda Norikazu, Ishikawa Takashi, Aruga Tomoyuki, Zarate Juan Pablo, Babbar Naveen, Balbin O. Alejandro, Yap Yoon-Sim

    BMC MEDICINE   21 巻 ( 1 ) 頁: 306   2023年8月

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    記述言語:英語   出版者・発行元:BMC Medicine  

    Background: There is increasing interest in the use of liquid biopsies, but data on longitudinal analyses of circulating tumor DNA (ctDNA) remain relatively limited. Here, we report a longitudinal ctDNA analysis of MONALEESASIA, a phase Ib trial evaluating the efficacy and safety of ribociclib plus endocrine therapy (ET) in Asian patients with hormone receptor–positive, human epidermal growth factor receptor-2–negative advanced breast cancer. Methods: MONALEESASIA enrolled premenopausal and postmenopausal Japanese and postmenopausal non-Japanese Asian patients. All patients received ribociclib with ET (letrozole, fulvestrant, or tamoxifen with goserelin). ctDNA was analyzed using a targeted next-generation sequencing panel of 572 cancer-related genes and correlated by best overall response (BOR). Results: Five hundred seventy-four cell-free DNA samples from 87 patients were tested. The most frequently altered genes at baseline included PIK3CA (29%) and TP53 (22%). Treatment with ribociclib plus ET decreased ctDNA in most patients at the first on-treatment time point, regardless of dose or ET partner. Patients with partial response and stable disease had lower ctDNA at baseline that remained low until data cutoff if no progressive disease occurred. Most patients with progressive disease as the best response had higher ctDNA at baseline that remained high at the end of treatment. For patients with partial response and stable disease with subsequent progression, ctDNA increased towards the end of treatment in most patients, with a median lead time of 83 days (14–309 days). In some patients with BOR of partial response who experienced disease progression later, specific gene alterations and total ctDNA fraction increased; this was sometimes observed concurrently with the development of new lesions without a change in target lesion size. Patients with alterations in PIK3CA and TP53 at baseline had shorter median progression-free survival compared with patients with wild-type PIK3CA and TP53, 12.7 and 7.3 months vs 19.2 and 19.4 months, respectively (P =.016 and P =.0001, respectively). Conclusions: Higher ctDNA levels and PIK3CA and TP53 alterations detected at baseline were associated with inferior outcomes. On-treatment ctDNA levels were associated with different patterns based on BOR. Longitudinal tracking of ctDNA may be useful for monitoring tumor status and detection of alterations with treatment implications. Trial registration: ClinicalTrials.gov NCT02333370 . Registered on January 7, 2015.

    DOI: 10.1186/s12916-023-03017-z

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  12. Fulvestrant with or without anti-HER2 therapy in patients in a postmenopausal hormonal state and with ER-positive HER2-positive advanced or metastatic breast cancer: A subgroup analysis of data from the Safari study (JBCRG-C06)

    Masuyama Misato, Masuda Norikazu, Kawaguchi Hidetoshi, Yamamoto Yutaka, Saji Shigehira, Nakayama Takahiro, Aogi Kenjiro, Anan Keisei, Ohtani Shoichiro, Sato Nobuaki, Takano Toshimi, Tokunaga Eriko, Nakamura Seigo, Hasegawa Yoshie, Hattori Masaya, Fujisawa Tomomi, Morita Satoshi, Yamaguchi Miki, Yamashita Toshinari, Yotsumoto Daisuke, Toi Masakazu, Ohno Shinji

    CANCER MEDICINE     2023年8月

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    記述言語:英語   出版者・発行元:Cancer Medicine  

    Background: The role of endocrine therapy in the treatment of patients in a postmenopausal hormonal state and with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced or metastatic breast cancer (AMBC) is unclear. Methods: We analyzed the data from 94 patients with ER-positive HER2-positive AMBC enrolled in the Safari study (UMIN000015168), a retrospective cohort study of 1072 ER-positive AMBC patients in a postmenopausal hormonal state who received fulvestrant 500 mg (F500): (1) to compare time to treatment failure (TTF) and overall survival (OS) by treatment group, and TTF by treatment line; (2) in patients who received endocrine therapy (including F500) or anti-HER2 therapy as initial systemic therapy before chemotherapy, to investigate relations between TTF for the first-line therapy or time to chemotherapy (TTC) and OS; (3) to investigate factors associated with OS. Results: The TTF was longer in the patients treated with F500 as first- or second-line therapy (n = 20) than in those who received later-line F500 therapy (n = 74) (6.6 vs. 3.7 months; HR, 1.98; p = 0.014). In the 59 patients who received endocrine therapy or anti-HER2 therapy as initial systemic therapy before chemotherapy, those with TTC ≥3 years had longer median OS than those with TTC <3 years (10.5 vs. 5.9 years; HR, 0.32; p = 0.001). Longer TTC was associated with prolonged OS. Conclusions: In patients with ER-positive HER2-positive AMBC enrolled in the Safari study, TTF was longer in patients who received F500 as first- or second-line therapy. In patients who received chemotherapy-free initial systemic therapy, the prolonged OS in those with TTC ≥3 years suggests that this value may be a helpful cut-off for indicating clinical outcomes.

    DOI: 10.1002/cam4.6390

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  13. Detection of high-risk patients resistant to CDK4/6 inhibitors with hormone receptor-positive HER2-negative advanced and metastatic breast cancer in Japan (KBCSG-TR-1316)

    Futamura Manabu, Nakayama Takahiro, Yoshinami Tetsuhiro, Oshiro Chiya, Ishihara Mikiya, Morita Midori, Watanabe Akira, Tanigichi Azusa, Tsukabe Masami, Shimoda Masafumi, Nitta Kanae, Chihara Yoko, Yasojima Hiroyuki, Ouchi Yoshimi, Tokumaru Yoshihisa, Masuda Norikazu

    BREAST CANCER     2023年7月

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    記述言語:英語   出版者・発行元:Breast Cancer  

    Background: Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) improve the prognosis of hormone receptor-positive HER2-negative advanced/metastatic breast cancer (HR+/HER2− mBC). However, some cancers show resistance to CDK4/6i and have a poor prognosis. The non-luminal disease score (NOLUS) was developed to predict non-luminal disease using immunohistochemical analysis. Methods: The association between the efficacy of CDK4/6i and NOLUS was investigated by evaluating pathological and clinical data, including real-world progression-free survival (rw-PFS) and overall survival (OS). Real-world data of patients with HR+/HER2− mBC who received CDK4/6i therapy [palbociclib or abemaciclib] as first- or second-line endocrine treatments was obtained. NOLUS was calculated using the formula: NOLUS (0–100) = − 0.45 × estrogen receptor (ER) (%) − 0.28 × progesterone receptor (PR) (%) + 0.27 × Ki67(%) + 73, and the patients were divided into two groups: NOLUS-positive (≥ 51.38) and NOLUS-negative (< 51.38). Results: Of the 300 patients, 28 (9.3%) were NOLUS-positive, and 272 (90.7%) were NOLUS-negative. The expression rates (%) of ER and PgR in NOLUS-positive patients were lower than those in NOLUS-negative patients (p < 0.001). Ki67 expression was higher in NOLUS-positive patients. There were statistically significant differences in prognosis (rw-PFS and OS) between the two groups. Moreover, NOLUS-negative patients showed statistically better rw-PFS with first-line therapy than second-line therapy. However, NOLUS-positive patients showed poor prognoses with both the first and second therapeutic lines, suggesting CDK4/6i inefficacy for NOLUS-positive patients. Conclusions: The efficacy and prognosis of CDK4/6i significantly differed between the NOLUS-positive and NOLUS-negative patients. This feasible method can predict patients with HR+/HER2− mBC resistant to CDK4/6i and help select a better therapeutic approach to overcome resistance.

    DOI: 10.1007/s12282-023-01485-y

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  14. OlympiAD extended follow-up for overall survival and safety: Olaparib versus chemotherapy treatment of physician?s choice in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer

    Robson Mark E., Im Seock-Ah, Senkus Elzbieta, Xu Binghe, Domchek Susan M., Masuda Norikazu, Delaloge Suzette, Tung Nadine, Armstrong Anne, Dymond Mike, Fielding Anitra, Allen Allison, Conte Pierfranco

    EUROPEAN JOURNAL OF CANCER   184 巻   頁: 39 - 47   2023年5月

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    記述言語:英語   出版者・発行元:European Journal of Cancer  

    Background: In the Phase III OlympiAD study, olaparib significantly prolonged progression-free survival versus chemotherapy treatment of physician's choice (TPC) in patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2-negative metastatic breast cancer (mBC). In the final pre-specified analysis (64% maturity), median overall survival (OS) was 19.3 months for olaparib and 17.1 months for TPC (P = 0.513). Post-hoc extended follow-up, 25.7 months longer than previously reported for OS, is reported. Patients and methods: Patients with gBRCAm, human epidermal growth factor receptor 2-negative mBC, who had received ≤2 lines of chemotherapy for metastatic disease, were randomised 2:1 to olaparib (300 mg bid) or TPC. During extended follow-up, OS was analysed every 6 months using the stratified log-rank test (overall population) and Cox proportional hazards model (pre-specified subgroups). Results: In the overall population (302 patients; 76.8% maturity), median OS was 19.3 months for olaparib and 17.1 months for TPC (hazard ratio 0.89, 95% confidence interval 0.67–1.18); median follow-up was 18.9 and 15.5 months, respectively. Three-year survival was 27.9% for olaparib versus 21.2% for TPC. With olaparib, 8.8% of patients received study treatment for ≥3 years versus none with TPC. In first-line mBC, median OS was longer for olaparib than TPC (22.6 versus 14.7 months; hazard ratio 0.55, 95% confidence interval 0.33–0.95) and 3-year survival was 40.8% for olaparib versus 12.8% for TPC. No new serious adverse events related to olaparib were observed. Conclusions: OS was consistent with previous analyses from OlympiAD. These findings support the possibility of meaningful long-term survival benefit with olaparib, particularly in first-line mBC.

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  15. Pembrolizumab plus chemotherapy in Japanese patients with triple-negative breast cancer: Results from KEYNOTE-355

    Hattori Masaya, Masuda Norikazu, Takano Toshimi, Tsugawa Koichiro, Inoue Kenichi, Matsumoto Koji, Ishikawa Takashi, Itoh Mitsuya, Yasojima Hiroyuki, Tanabe Yuko, Yamamoto Keiko, Suzuki Masato, Pan Wilbur, Cortes Javier, Iwata Hiroji

    CANCER MEDICINE   12 巻 ( 9 ) 頁: 10280 - 10293   2023年5月

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    記述言語:英語   出版者・発行元:Cancer Medicine  

    Pembrolizumab plus chemotherapy improved progression-free survival (PFS) and overall survival (OS) compared with placebo plus chemotherapy in patients with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer with tumor programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥10 in the global, phase 3, randomized controlled trial KEYNOTE-355. We report results for patients enrolled in Japan. Patients were randomized 2:1 to pembrolizumab 200 mg or placebo Q3W for 35 cycles plus chemotherapy (nab-paclitaxel, paclitaxel, or gemcitabine–carboplatin). Primary endpoints were PFS per RECIST version 1.1 by blinded independent central review and OS in patients with PD-L1 CPS ≥10, PD-L1 CPS ≥1, and the intention-to-treat (ITT) population. No alpha was assigned to this exploratory analysis. Eighty-seven patients were randomized in Japan (pembrolizumab plus chemotherapy, n = 61; placebo plus chemotherapy, n = 26), 66 (76%) had PD-L1 CPS ≥1, and 28 (32%) had PD-L1 CPS ≥10. Median time from randomization to data cutoff (June 15, 2021) was 44.7 (range, 37.2–52.9) months in the ITT population. Hazard ratios (HRs; 95% CI) for OS were 0.36 (0.14–0.89), 0.52 (0.30–0.91), and 0.46 (0.28–0.77) in the PD-L1 CPS ≥10, PD-L1 CPS ≥1, and ITT populations, respectively. HRs (95% CI) for PFS were 0.52 (0.20–1.34), 0.61 (0.35–1.06), and 0.64 (0.39–1.05). Grade 3 or 4 treatment-related adverse events occurred in 85% of patients in each group (no grade 5 events). Consistent with the global population, pembrolizumab plus chemotherapy tended to show improvements in OS and PFS with manageable toxicity versus placebo plus chemotherapy in Japanese patients and supports this combination in this setting.

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  16. Overall survival with neratinib after trastuzumab-based adjuvant therapy in HER2-positive breast cancer (ExteNET): A randomised, double-blind, placebo-controlled, phase 3 trial

    Holmes Frankie A., Moy Beverly, Delaloge Suzette, Chia Stephen K. L., Ejlertsen Bent, Mansi Janine, Iwata Hiroji, Gnant Michael, Buyse Marc, Barrios Carlos H., Silovski Tajana, Separovic Robert, Bashford Anna, Zotano Angel Guerrero, Denduluri Neelima, Patt Debra, Gokmen Erhan, Gore Ira, Ii John W. Smith, Loibl Sibylle, Masuda Norikazu, Tomasevic Zorica, Petrakova Katarina, DiPrimeo Daniel, Wong Alvin, Martin Miguel, Chan Arlene

    EUROPEAN JOURNAL OF CANCER   184 巻   頁: 48 - 59   2023年5月

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    記述言語:英語   出版者・発行元:European Journal of Cancer  

    Background: ExteNET showed that neratinib, an irreversible pan-HER tyrosine kinase inhibitor, given for 1 year after trastuzumab-based therapy significantly improved invasive disease-free survival in women with early-stage HER2-positive breast cancer. We report the final analysis of overall survival in ExteNET. Methods: In this international, randomised, double-blind, placebo-controlled, phase 3 trial, women aged 18 years or older with stage 1–3c (amended to stage 2–3c) HER2-positive breast cancer who had completed neoadjuvant and adjuvant chemotherapy plus trastuzumab were eligible. Patients were randomly assigned to oral neratinib 240 mg/day or placebo for 1 year. Randomisation was stratified according to hormone receptor (HR) status (HR-positive vs. HR-negative), nodal status (0, 1–3 or 4+), and trastuzumab regimen (sequentially vs. concurrently with chemotherapy). Overall survival was analysed by intention to treat. ExteNET is registered (Clinicaltrials.gov: NCT00878709) and is complete. Results: Between July 9, 2009, and October 24, 2011, 2840 women received neratinib (n = 1420) or placebo (n = 1420). After a median follow-up of 8.1 (IQR, 7.0–8.8) years, 127 patients (8.9%) in the neratinib group and 137 patients (9.6%) in the placebo group in the intention-to-treat population had died. Eight-year overall survival rates were 90.1% (95% CI 88.3–91.6) with neratinib and 90.2% (95% CI 88.4–91.7) with placebo (stratified hazard ratio 0.95; 95% CI 0.75–1.21; p = 0.6914). Conclusions: Overall survival in the extended adjuvant setting was comparable for neratinib and placebo after a median follow-up of 8.1 years in women with early-stage HER2-positive breast cancer.

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  17. Fulvestrant plus palbociclib in advanced or metastatic hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer after fulvestrant monotherapy: Japan Breast Cancer Research Group-M07 (FUTURE trial)

    Watanabe Kenichi, Niikura Naoki, Kikawa Yuichiro, Oba Mari, Kobayashi Kokoro, Tada Hiroshi, Ozaki Shinji, Toh Uhi, Yamamoto Yutaka, Tsuneizumi Michiko, Okuno Toshitaka, Iwakuma Nobutaka, Takeshita Takashi, Iwamoto Takayuki, Ishiguro Hiroshi, Masuda Norikazu, Saji Shigehira

    BREAST CANCER RESEARCH AND TREATMENT   199 巻 ( 2 ) 頁: 253 - 263   2023年3月

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    記述言語:英語   出版者・発行元:Breast Cancer Research and Treatment  

    Purpose: The combination of cyclin-dependent kinase 4/6 inhibitors and endocrine therapy is a standard treatment for hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC); however, their toxicities and financial burden are major issues, especially for prolonged treatment. We investigated fulvestrant plus palbociclib in patients with HR-positive MBC resistant to fulvestrant monotherapy. Methods: Patients who initially received fulvestrant as their first- or second-line endocrine therapy were assigned to group A. Patients with disease progression during fulvestrant monotherapy who subsequently received fulvestrant plus palbociclib were assigned to group B. The primary endpoint was progression-free survival (PFS1) in group B. We set the threshold median PFS of 5 months (null hypothesis). Results: Between January 2018 and February 2020 we enrolled 167 patients in group A (January 2018–February 2020) from 55 institutions, of whom 72 subsequently received fulvestrant plus palbociclib and were enrolled in group B. The median follow-up was 23.8 and 8.9 months in groups A and B, respectively. The median PFS in group B (combination therapy) was 9.4 (90% confidence interval [CI]: 6.9–11.2) months (p < 0.001). This was 25.7 (90% CI: 21.2–30.3) months in group A (fulvestrant monotherapy). The TTF in group B was 7.2 (90% CI: 5.5–10.4) months. In the post-hoc analysis, the median PFS1 in group B among patients with longer-duration fulvestrant monotherapy (> 1 year) was longer than that of patients with shorter-duration monotherapy (≤ 1 year) (11.3 vs. 7.6 months). No new toxicities were observed. Conclusion: Our findings suggest that palbociclib plus fulvestrant after disease progression despite fulvestrant monotherapy is potentially safe and effective in patients with HR-positive/HER2-negative advanced MBC.

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  18. Phase III study of long-term prognosis of estrogen receptor-positive early breast cancer treated with neoadjuvant endocrine therapy with/without adjuvant chemotherapy

    Iwata Hiroji, Yamamoto Yutaka, Sakai Takehiko, Hasegawa Yoshie, Nakamura Rikiya, Akabane Hiromitsu, Ohtani Shoichiro, Kashiwaba Masahiro, Taira Naruto, Toyama Tatsuya, Fujisawa Tomomi, Masuda Norikazu, Shibahara Yukiko, Sasano Hironobu, Yamaguchi Takuhiro

    BREAST CANCER RESEARCH AND TREATMENT   199 巻 ( 2 ) 頁: 231 - 241   2023年3月

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    記述言語:英語   出版者・発行元:Breast Cancer Research and Treatment  

    Purpose: Neoadjuvant endocrine therapy (NET) is a treatment option for estrogen receptor-positive (ER+) postmenopausal early breast cancer (EBC). This phase III trial evaluated the prognosis of EBC patients treated with/without chemotherapy (CT) following NET. Methods: ER+/HER2−, T1c-2, and clinically node-negative EBC patients were enrolled in 2008–2013 and treated with endocrine therapy (ET) in weeks 24–28. All patients, excluding those with progressive disease (PD) during NET or ≥ 4 positive lymph nodes after surgery, were randomized to ET for 4.5–5 years with/without CT. The primary endpoint was disease-free survival (DFS). Secondary endpoints included distant DFS (DDFS), overall survival (OS), and DFS/DDFS/OS according to clinical response to NET. Results: Of 904 patients, 669 were randomized to CT+ET (n = 333) or ET alone (n = 336). The median follow-up was 7.8 years. DFS (CT+ET, 47 events; ET alone, 70 events) and DDFS did not reach the planned numbers of events. Eight-year DFS/DDFS rates were 86%/93% and 83%/92%, respectively. DFS was significantly better in CT+ET than ET alone in subgroups aged < 60 years (P = 0.016), T2 (P = 0.013), or Ki67 > 20% (P = 0.026). Progesterone receptor and histological grade were predictive markers for clinical responses to NET. Conclusion: NET may be used as standard treatment for patients with ER+EBC. Although it is difficult to decide whether to administer adjuvant CT based solely on the effect of NET, the response to NET may help to inform this decision. Trial registration: This study was registered at the UMIN Clinical Trials Registry under UMIN000001090 (registered 20 March 2008).

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  19. Retrospective study on the effectiveness of medroxyprogesterone acetate in the treatment of ER-positive/HER2-negative post-menopausal advanced breast cancer: an additional analysis of the JBCRG-C06 Safari study

    Kawaguchi Hidetoshi, Yamamoto Yutaka, Saji Shigehira, Masuda Norikazu, Nakayama Takahiro, Aogi Kenjiro, Anan Keisei, Ohtani Shoichiro, Sato Nobuaki, Takano Toshimi, Tokunaga Eriko, Nakamura Seigo, Hasegawa Yoshie, Hattori Masaya, Fujisawa Tomomi, Morita Satoshi, Yamaguchi Miki, Yamashita Toshinari, Yotsumoto Daisuke, Toi Masakazu, Ohno Shinji

    JAPANESE JOURNAL OF CLINICAL ONCOLOGY   53 巻 ( 3 ) 頁: 203 - 211   2023年3月

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    記述言語:英語   出版者・発行元:Japanese Journal of Clinical Oncology  

    Background: Only old evidence exists to back up the use of medroxyprogesterone acetate. Therefore, this study aimed to explore the factors that influence the time to treatment failure of medroxyprogesterone acetate in real-world settings as late-line treatment. Methods: This was a cohort study that used the database of the Safari study on oestrogen receptor-positive post-menopausal advanced breast cancer (UMIN000015168). We created Kaplan-Meier curves for time to treatment failure with medroxyprogesterone acetate. Further, univariate and multivariate analyses were performed using a Cox hazard model of the clinicopathological factors involved in the time to treatment failure of medroxyprogesterone acetate. Results: From the 1031 patients in the Safari study, 279 patients were selected as the population for the analysis of effectiveness of medroxyprogesterone acetate monotherapy. In the analysis of medroxyprogesterone acetate by treatment line, the median time to treatment failure was 3.0 months for third-line treatment and 4.1 months for fourth and subsequent treatment lines. In cases where medroxyprogesterone acetate was used as a third-line or later endocrine treatment, multivariate analysis showed that the length of the disease-free interval was correlated with the length of time to treatment failure of medroxyprogesterone acetate (P = 0.004). With medroxyprogesterone acetate monotherapy as the fourth-line or later treatment, 20% of the patients achieved a time to treatment failure of 12 months or longer. Conclusion: In actual clinical practice, patients treated with medroxyprogesterone acetate alone as the fourth or subsequent treatment lines showed a time to treatment failure of 4 months, suggesting that there is merit in using medroxyprogesterone acetate even in late treatment lines, especially in patients with long disease-free interval and those who are difficult to treat using other antineoplastic agents.

    DOI: 10.1093/jjco/hyac184

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  20. 乳がん トリプルネガティブ乳がん(TNBC)

    高野悠子,増田慎三

    がん 最新の薬物療法2023-2024     頁: 124 - 128   2023年3月

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    出版者・発行元:南江堂  

  21. Efficacy and exploratory biomarker analysis of entinostat plus exemestane in advanced or recurrent breast cancer: phase II randomized controlled trial

    Iwata Hiroji, Nakamura Rikiya, Masuda Norikazu, Yamashita Toshinari, Yamamoto Yutaka, Kobayashi Kokoro, Tsurutani Junji, Iwasa Tsutomu, Yonemori Kan, Tamura Kenji, Aruga Tomoyuki, Tokunaga Eriko, Kaneko Koji, Lee Min-Jung, Yuno Akira, Kawabata Azusa, Seike Toshihiro, Kaneda Ayumi, Nishimura Yozo, Trepel Jane B., Saji Shigehira

    JAPANESE JOURNAL OF CLINICAL ONCOLOGY   53 巻 ( 1 ) 頁: 4 - 15   2023年1月

  22. A prospective analysis of two studies that used the 5-mm interval slices and 5-mm margin-free method for ipsilateral breast tumor recurrence after breast-conserving surgery without radiotherapy

    Ohsumi Shozo, Nishimura Reiki, Masuda Norikazu, Akashi-Tanaka Sadako, Suemasu Kimito, Yamauchi Hideko, Tokunaga Eriko, Ikeda Tadashi, Nishi Tsunehiro, Hayashi Hiroto, Iino Yuichi, Takatsuka Yuichi, Ohashi Yasuo, Inaji Hideo

    BREAST CANCER   30 巻 ( 1 ) 頁: 131 - 138   2023年1月

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    記述言語:英語   出版者・発行元:Breast Cancer  

    Background: Breast-conserving surgery with radiotherapy is one of standard treatments for early breast cancer. However, it is regarded as an option to treat elderly patients with small hormone receptor-positive breast cancer with breast-conserving surgery and hormone therapy without radiotherapy. We conducted two sequential prospective studies to examine the feasibility of breast-conserving surgery without radiotherapy since 2002 and present the results. Patients and methods: Primary female breast cancer patients who fulfilled the strict eligibility criteria were prospectively enrolled in two sequential studies named WORTH 1 and 2. The surgical materials were sliced in 5-mm intervals and all slices were examined microscopically. Postoperative radiotherapy was not allowed, but tamoxifen or anastrozole was administered for 5 years. Ipsilateral breast tumor recurrence (IBTR)-free survival was the primary outcome. Results: The data of the two studies were combined (N = 321). The median follow-up period for IBTR was 94 months (4–192 months). Only three patients were treated with adjuvant chemotherapy. The 5- and 10-year IBTR-free rates were 97.0% and 90.5%, respectively. The age at operation and PR status affected IBTR rates independently. When we calculated IBTR-free rates of patients who were 65 years of age or older at the time of surgery and had PR-positive tumors, the 5- and 10-year IBTR rates were both 98.4%. Conclusions: Our “5-mm-thick slice and 5-mm free-margin” method may be effective to select patients who can be treated by breast-conserving surgery and hormone therapy without radiotherapy.

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  23. Patient characteristics, treatment patterns, and outcomes of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer patients prescribed cyclin-dependent kinase 4 and 6 inhibitors: large-scale data analysis using a Japanese claims database

    Kawai Masaaki, Takada Masahiro, Nakayama Takahiro, Masuda Norikazu, Shiheido Hirokazu, Cai Zhihong, Huang Yu-Jing, Kawaguchi Tsutomu, Tanizawa Yoshinori

    BREAST CANCER RESEARCH AND TREATMENT   197 巻 ( 2 ) 頁: 435 - 447   2023年1月

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    記述言語:英語   出版者・発行元:Breast Cancer Research and Treatment  

    Purpose: The aim was to understand real-world cyclin-dependent kinase (CDK) 4 and 6 inhibitor use in Japan. Methods: This retrospective observational study used a Japanese administrative claims database and included patients with presumptive hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (ABC) prescribed CDK4 and 6 inhibitor therapy between December 2017 and March 2021. Patient characteristics, treatment patterns, and selected clinical and safety outcomes were descriptively summarized. Time to discontinuation (TTD) and chemotherapy-free survival (CFS) were examined using Kaplan–Meier estimates. Results: The study cohort (N = 6442) was predominantly female (99.4%; median [range] age 64 [26–99] years) with records of metastases (79.6%) within 1 year prior to initiating CDK4 and 6 inhibitor therapy. In total, 4463 (69.3%) and 1979 (30.7%) were prescribed palbociclib and abemaciclib, respectively, as their first CDK4 and 6 inhibitor, most commonly in combination with fulvestrant (n = 3801; 59.0%). Overall, 3756 patients initiated a subsequent anticancer treatment, of whom 748 (19.9%) initiated a different CDK4 and 6 inhibitor in combination with the same or different endocrine therapy. Median TTD (95% confidence interval) was 9.7 (9.3, 10.1) months for the first CDK4 and 6 inhibitor therapy. Median CFS was 26.1 (24.6, 27.8) months. Incidence of clinically relevant diarrhea was higher after abemaciclib initiation (9.8%) than after palbociclib initiation (1.5%). More patients experienced dose reduction with palbociclib (69.3%) than with abemaciclib (53.0%). Conclusion: The data provide insights into current clinical practices for CDK4 and 6 inhibitor use in Japan that could help establish future treatment strategies for ABC.

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  24. Liposomal eribulin for advanced adenoid cystic carcinoma, gastric cancer, esophageal cancer, and small cell lung cancer

    Udagawa Hibiki, Takahashi Shunji, Hirao Motohiro, Tahara Makoto, Iwasa Satoru, Sato Yasuyoshi, Hamakawa Takuya, Shitara Kohei, Horinouchi Hidehito, Chin Keisho, Masuda Norikazu, Suzuki Takuya, Okumura Shiori, Takase Takao, Nagai Reiko, Yonemori Kan

    CANCER MEDICINE   12 巻 ( 2 ) 頁: 1269 - 1278   2023年1月

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    記述言語:英語   出版者・発行元:Cancer Medicine  

    Background: In this open-label, Phase 1 study, we explore the safety and efficacy of E7389-LF (liposomal formulation of eribulin) in Japanese patients with advanced solid tumors. Methods: This open-label, Phase 1 study enrolled Japanese adult patients to receive E7389-LF for the treatment of advanced solid tumors. Treatment with E7389-LF 2.0 mg/m2 every 3 weeks (previously determined maximum tolerated dose) was tested for the treatment of adenoid cystic carcinoma, gastric cancer, esophageal cancer, or small lung cell cancer in the expansion part of this study. Secondary endpoints included safety, objective response rate, best overall response, and progression-free survival. Results: As of October 16, 2020, 43 patients were enrolled (adenoid cystic carcinoma, n = 12; gastric cancer, n = 10; esophageal cancer, n = 11; small cell lung cancer, n = 10). Thirty-three patients experienced a Grade ≥3 treatment-related treatment-emergent adverse event, most commonly neutropenia (53.5%). Additionally, the incidence of hypersensitivity did not appear to change with a reduced number of infusion steps (2 vs. 4) and patients who were administered prophylactic pegylated granulocyte-colony stimulating factor had a noticeably lower incidence of Grade 3–4 neutropenia (although this did not have a proper control). The overall objective response rate was 11.6% (95% confidence interval: 3.9–25.1), corresponding to two partial responses in patients with adenoid cystic carcinoma, two partial responses in gastric cancer, and one partial response in esophageal cancer. Median progression-free survival was longer in the adenoid cystic carcinoma population (16.6 months) than in others. Conclusions: E7389-LF 2.0 mg/m2 every 3 weeks was well tolerated for the treatment of several different tumor types, and larger studies in these populations are warranted.

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  25. 長期間の画像所見の変遷から考える 甲状腺癌未分化転化の1症例

    柴田雅央,大川哲司,三井伸二,山本美里,浅井真理子,福岡恵,秋田由美子,杉野香世子,一川貴洋,添田郁美,岩瀬まどか,高野悠子,武内大,菊森豊根,増田慎三

    乳腺甲状腺超音波医学   12 巻 ( 3 ) 頁: 11 - 16   2023年

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    出版者・発行元:日本乳腺甲状腺超音波医学会(JABTS)  

  26. HDR-brachytherapy for accelerated partial breast irradiation: Long-term experience from a Japanese institution

    Yoshida K, Kotsuma T, Takaoka Y, Tamenaga S, Yamazaki H, Nose T, Murakami N, Inaba K, Akiyama H, Masui K, Takenaka T, Kubota H, Tselis N, Masuda N, Yasojima H, Takeda M, Mano M, Nakamura S, Utsunomiya K, Tanigawa N, Tanaka E

    Journal of Contemporary Brachytherapy   15 巻 ( 1 ) 頁: 1 - 8   2023年

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    記述言語:英語   出版者・発行元:Journal of Contemporary Brachytherapy  

    Purpose: We investigated the long-term oncological outcome of high-dose-rate (HDR) multicatheter interstitial brachytherapy (MIB) for adjuvant accelerated partial breast irradiation (APBI) after breast conserving surgery in Japanese patients. Material and methods: Between June 2002 and October 2011, 86 breast cancer patients were treated at National Hospital Organization Osaka National Hospital (trial number of the local institutional review board, 0329). Median age was 48 years (range, 26-73 years). Eighty patients had invasive and 6 patients non-invasive ductal carcinoma. Tumor stage distribution was pT0 in 2, pTis in 6, pT1 in 55, pT2 in 22, and pT3 in one patient, respectively. Twenty-seven patients had close/positive resection margins. Total physical HDR dose was 36-42 Gy in 6-7 fractions. Results: At a median follow-up of 119 months (range, 13-189 months), the 10-year local control (LC) and overall survival rate was 93% and 88%, respectively. Concerning the 2009 Groupe Européen de Curiethérapie-European Society for Therapeutic Radiology and Oncology risk stratification scheme, the 10-year LC rate was 100%, 100%, and 91% for patients considered as low-risk, intermediate-risk, and high-risk, respectively. According to the 2018 American Brachytherapy Society risk stratification scheme, the 10-year LC rate was 100% and 90% for patients ‘acceptable’ and ‘unacceptable’ for APBI, respectively. Wound complications were observed in 7 patients (8%). Risk factors for wound complications were the omission of prophylactic antibiotics during MIB, open cavity implantation, and V100 ≥ 190 cc. No grade ≥ 3 late complications (CTCVE version 4.0) were observed. Conclusions: Adjuvant APBI using MIB is associated with favorable long-term oncological outcomes in Japanese patients for low-risk, intermediate-risk, and acceptable groups of patients.

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  27. Ⅳ. Clinical Trials on OncotypeDX-TAILORx and JBCRG-TR003 Trial

    Iwase M., Masuda N.

    Gan to kagaku ryoho. Cancer &amp; chemotherapy   49 巻 ( 12 ) 頁: 1324 - 1327   2022年12月

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    出版者・発行元:Gan to kagaku ryoho. Cancer &amp; chemotherapy  

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  28. Ⅳ. Clinical Trials on OncotypeDX-TAILORx and JBCRG-TR003 Trial

    Iwase M, Masuda N

    Gan to kagaku ryoho. Cancer &amp; chemotherapy   49 巻 ( 12 ) 頁: 1324 - 1327   2022年12月

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    出版者・発行元:Gan to kagaku ryoho. Cancer &amp; chemotherapy  

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  29. [Ⅳ. Clinical Trials on OncotypeDX-TAILORx and JBCRG-TR003 Trial].

    Iwase M, Masuda N

    Gan to kagaku ryoho. Cancer & chemotherapy   49 巻 ( 12 ) 頁: 1324 - 1327   2022年12月

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    記述言語:日本語  

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  30. [Ⅳ. Clinical Trials on OncotypeDX-TAILORx and JBCRG-TR003 Trial].

    Iwase M, Masuda N

    Gan to kagaku ryoho. Cancer & chemotherapy   49 巻 ( 12 ) 頁: 1324 - 1327   2022年12月

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    記述言語:日本語  

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  31. Data of programmed death-ligand 1 bevacizumab and paclitaxel For HER2-negative

    Ozaki Yukinori, Tsurutani Junji, Mukohara Toru, Iwasa Tsutomu, Takahashi Masato, Tanabe Yuko, Kawabata Hidetaka, Masuda Norikazu, Futamura Manabu, Minami Hironobu, Matsumoto Koji, Yoshimura Kenichi, Kitano Shigehisa, Takano Toshimi

    DATA IN BRIEF   45 巻   頁: 108558   2022年12月

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  32. Efficacy and safety of talazoparib in Japanese patients with germline BRCA-mutated locally advanced or metastatic breast cancer: results of the phase 1 dose-expansion study

    Kotani Haruru, Masuda Norikazu, Yamashita Toshinari, Naito Yoichi, Taira Tetsuhiko, Inoue Kenichi, Takahashi Masato, Yonemori Kan, Toyoizumi Shigeyuki, Mori Yuko, Nagasawa Takashi, Hori Natsuki, Iwata Hiroji

    BREAST CANCER   29 巻 ( 6 ) 頁: 1088 - 1098   2022年11月

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    記述言語:英語   出版者・発行元:Breast Cancer  

    Background: Talazoparib, a poly(ADP-ribose) polymerase enzyme inhibitor, is approved for the treatment of patients with germline BRCA1/2 (gBRCA1/2)-mutated HER2-negative advanced breast cancer. This two-part study, a recently published dose-escalation part followed by the dose-expansion part reported here, evaluated the efficacy and safety of talazoparib in Japanese patients with gBRCA1/2-mutated advanced breast cancer. Methods: In this open-label, multicenter phase 1 study (NCT03343054), the primary endpoint of the dose-expansion part was confirmed objective response rate (ORR), determined by investigator assessment (RECIST 1.1). Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and pharmacokinetics. Patients received the recommended phase 2 dose (1 mg/day; 0.75 mg/day moderate renal impairment). Results: Nineteen Japanese patients with gBRCA1/2-mutated locally advanced or metastatic breast cancer were enrolled. Confirmed ORR was 57.9% (11/19; 90% confidence interval [CI] 36.8–77.0). Stable disease was observed in 36.8% (7/19) of patients. Per investigator assessment, median PFS was 7.2 months (95% CI 4.1–not estimable) and 12-month OS rate was 84.7% (90% CI 57.5–95.1). Median OS was not reached; 17/19 patients were alive and censored at 12 months. All patients experienced treatment-related adverse events (AEs); the majority were hematologic. The most common treatment-related AE was anemia (68.4%; [13/19]). Grade 3/4 treatment-related AEs were observed in 52.6% (10/19) of patients. During the safety period, there were no grade 5 treatment-emergent AEs, treatment-related serious AEs, or deaths. Conclusions: In Japanese patients with gBRCA mutations and locally advanced or metastatic breast cancer, talazoparib monotherapy was generally well tolerated and resulted in clinically meaningful ORRs. Clinicaltrials.gov identifier: NCT03343054.

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  33. Pembrolizumab plus Chemotherapy vs Placebo plus Chemotherapy by PD-L1 Combined Positive Scores 1-9, 10-19, and >= 20 for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer: KEYNOTE-355 Subgroup Analysis

    Loi Sherene, Cescon DavidW, Rugo Hope S, Nowecki Zbigniew, Im Seock-Ah, Yusof Mastura Md, Gallardo Carlos, Lipatov Oleg, Barrios Carlos Henrique, Perez-Garcia Jose, Iwata Hiroji, Masuda Norikazu, Torregroza Otero Marco, Gokmen Erhan, Guo Zifang, Zhou Xuan, Karantza Vassiliki, Pan Wilbur, Schmid Peter, Cortes Javier, Douglas Julia

    ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY   18 巻   頁: 133 - 133   2022年11月

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  34. Pembrolizumab plus Chemotherapy vs Placebo plus Chemotherapy by PD-L1 Combined Positive Scores 1-9, 10-19, and >= 20 for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple-Negative Breast Cancer: KEYNOTE-355 Subgroup Analysis

    Loi Sherene, Cescon DavidW., Rugo Hope S., Nowecki Zbigniew, Im Seock-Ah, Yusof Mastura Md, Gallardo Carlos, Lipatov Oleg, Barrios Carlos Henrique, Perez-Garcia Jose, Iwata Hiroji, Masuda Norikazu, Torregroza Otero Marco, Gokmen Erhan, Guo Zifang, Zhou Xuan, Karantza Vassiliki, Pan Wilbur, Schmid Peter, Cortes Javier, Douglas Julia

    ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY   18 巻   頁: 133 - 133   2022年11月

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  35. Subgroup analysis of Japanese patients in a phase III randomized, controlled study of neoadjuvant atezolizumab or placebo, combined with nab-paclitaxel and anthracycline-based chemotherapy in early triple-negative breast cancer (IMpassion031)

    Saji Shigehira, Ohsumi Shozo, Ito Mitsuya, Hayashi Naoki, Kobayashi Kokoro, Masuda Norikazu, Niikura Naoki, Yamashita Toshinari, Kiyama Keiichiro, Hasegawa Ayumi, Nakagawa Shizuka, Hattori Masaya

    JAPANESE JOURNAL OF CLINICAL ONCOLOGY   52 巻 ( 10 ) 頁: 1124 - 1133   2022年10月

  36. Elevated TSH Level, TgAb, and Prior Use of Ramucirumab or TKIs as Risk Factors for Thyroid Dysfunction in PD-L1 Blockade

    Kobayashi Tomoko, Iwama Shintaro, Yamagami Ayana, Yasuda Yoshinori, Okuji Takayuki, Ito Masaaki, Zhou Xin, Ando Masahiko, Onoue Takeshi, Miyata Takashi, Sugiyama Mariko, Hagiwara Daisuke, Suga Hidetaka, Banno Ryoichi, Hase Tetsunari, Morise Masahiro, Ito Takanori, Kikumori Toyone, Inoue Megumi, Ando Yuichi, Masuda Norikazu, Kawashima Hiroki, Hashimoto Naozumi, Arima Hiroshi

    JOURNAL OF CLINICAL ENDOCRINOLOGY & METABOLISM   107 巻 ( 10 ) 頁: E4115 - E4123   2022年9月

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    記述言語:英語   出版者・発行元:Journal of Clinical Endocrinology and Metabolism  

    Background: Thyroid dysfunction is frequently caused by treatment with antiprogrammed cell death-1 ligand 1 antibodies (PD-L1-Abs) and anticancer drugs, including ramucirumab (RAM) and multitargeted tyrosine kinase inhibitors (multi-TKIs), which are often used prior to PD-L1-Ab treatment in cancer patients. Methods: A total of 148 patients treated with PD-L1-Abs were evaluated for antithyroid antibodies at baseline and for thyroid function every 6 weeks for 24 weeks after treatment initiation and then were observed until the visits stopped. Results: Of the 148 patients, 15 (10.1%) developed thyroid dysfunction after PD-L1-Ab treatment (destructive thyroiditis in 8 and hypothyroidism without preceding thyrotoxicosis in 7). The prevalence of an elevated thyroid-stimulating hormone (TSH) level at baseline (3/15 [20.0%] vs 4/133 [3.0%], P < .05), positive antithyroglobulin antibodies (TgAbs) at baseline (4/15 [26.7%] vs 5/133 [3.8%], P < .05) and prior treatment with RAM or multi-TKIs (3/15 [20.0%] vs 5/133 [3.8%], P < .05) were significantly higher in patients with vs without thyroid dysfunction. In a multivariate analysis, elevated TSH level at baseline, TgAb positivity at baseline, and prior treatment with RAM or multi-TKIs were significantly associated with the development of thyroid dysfunction, with ORs of 7.098 (95% CI 1.154-43.638), 11.927 (95% CI 2.526-56.316), and 8.476 (95% CI 1.592-45.115), respectively. Conclusion: The results of this real-world study suggest that the risk of thyroid dysfunction induced by PD-L1-Abs can be predicted by the TSH level at baseline, TgAb positivity at baseline, and prior treatment with RAM or multi-TKIs.

    DOI: 10.1210/clinem/dgac467

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  37. 術前薬物療法による残存病変に基づく治療選択(residual disease-guided approach)と個別化治療の展望

    増田慎三

    乳癌の臨床   37 巻 ( 4 ) 頁: 287 - 298   2022年9月

  38. Pertuzumab retreatment for HER2-positive advanced breast cancer: A randomized, open-label phase III study (PRECIOUS)

    Yamamoto Yutaka, Iwata Hiroji, Taira Naruto, Masuda Norikazu, Takahashi Masato, Yoshinami Tetsuhiro, Ueno Takayuki, Toyama Tatsuya, Yamanaka Takashi, Takano Toshimi, Kashiwaba Masahiro, Tsugawa Koichiro, Hasegawa Yoshie, Tamura Kenji, Tada Hiroshi, Hara Fumikata, Fujisawa Tomomi, Niikura Naoki, Saji Shigehira, Morita Satoshi, Toi Masakazu, Ohno Shinji

    CANCER SCIENCE   113 巻 ( 9 ) 頁: 3169 - 3179   2022年9月

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    記述言語:英語   出版者・発行元:Cancer Science  

    No standard options existed for human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer that progresses after second-line trastuzumab emtansine therapy before 2020. The purpose of this study was to examine the efficacy of pertuzumab retreatment after disease progression following pertuzumab-containing therapy for HER2-positive locally advanced or metastatic breast cancer for the first time. This randomized, open-label, multicenter phase III trial was undertaken in 93 sites in Japan. Eligible patients with HER2-positive breast cancer who had received pertuzumab, trastuzumab, and chemotherapy as first- and/or second-line therapy were randomly assigned (1:1) to: (i) pertuzumab, trastuzumab, and physician's choice chemotherapy (PTC), or (ii) trastuzumab and physician's choice chemotherapy (TC). The primary end-point was investigator-assessed progression-free survival (PFS). Between August 1, 2015 and December 31, 2018, 219 patients were randomized to PTC (n = 110) or TC (n = 109). Median follow-up was 14.2 months (interquartile range, 9.0–22.2), and median PFS was 5.3 months (95% confidence interval [CI], 4.0–6.6) with PTC and 4.2 months (95% CI, 3.2–4.8) with TC (stratified hazard ratio 0.76 [95% CI upper limit 0.967]; p = 0.022). Progression-free survival was improved by adding pertuzumab in all prespecified subgroups. The PTC arm showed a trend towards better overall survival and duration of response, but similar objective response and health-related quality of life. The incidence of treatment-related adverse events was similar between groups except for diarrhea. Pertuzumab retreatment contributes to disease control for HER2-positive locally advanced or metastatic breast cancer previously treated with pertuzumab-containing regimens.

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  39. Fulvestrant with additional palbociclib in advanced or metastatic hormone receptor-positive HER2-negative breast cancer after progression to fulvestrant monotherapy: JBCRG-M07 (FUTURE trial)

    Watanabe K., Niikura N., Kikawa Y., Oba M., Kobayashi K., Tada H., Ozaki S., Toh U., Yamamoto Y., Tsuneizumi M., Okuno T., Iwakuma N., Takeshita T., Iwamoto T., Ishiguro H., Masuda N., Saji S.

    ANNALS OF ONCOLOGY   33 巻 ( 7 ) 頁: S642 - S642   2022年9月

  40. Difference of immunological status and response to immune checkpoint inhibitor between recurrent and de novo stage IV HER2-negative breast cancer in NEWBEAT trial (WJOG9917BTR)

    Ozaki Y., Kitano S., Yamashita M., Ikarashi D., Tsurutani J., Iwasa T., Takahashi M., Mukohara T., Masuda N., Futamura M., Minami H., Matsumoto K., Hashimoto Y. Tanabe, Kawabata H., Yoshimura K., Takano T.

    ANNALS OF ONCOLOGY   33 巻 ( 7 ) 頁: S654 - S654   2022年9月

  41. 術前治療

    増田 慎三

    乳癌診療     頁: 529 - 532   2022年9月

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    出版者・発行元:医歯薬出版  

  42. Overall Survival with Palbociclib and Fulvestrant in Women with HR+/HER2(- )ABC: Updated Exploratory Analyses of PALOMA-3, a Double-blind, Phase III Randomized Study

    Cristofanilli Massimo, Rugo Hope S., Im Seock-Ah, Slamon Dennis J., Harbeck Nadia, Bondarenko Igor, Masuda Norikazu, Colleoni Marco, DeMichele Angela, Loi Sherene, Iwata Hiroji, O'Leary Ben, Andre Fabrice, Loibl Sibylle, Bananis Eustratios, Liu Yuan, Huang Xin, Kim Sindy, Frean Maria Jose Lechuga, Turner Nicholas C.

    CLINICAL CANCER RESEARCH   28 巻 ( 16 ) 頁: 3433 - 3442   2022年8月

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    記述言語:英語   出版者・発行元:Clinical Cancer Research  

    Purpose: To conduct an updated exploratory analysis of overall survival (OS) with a longer median follow-up of 73.3 months and evaluate the prognostic value of molecular analysis by circulating tumor DNA (ctDNA). Patients and Methods: Patients with hormone receptor–positive/ human epidermal growth factor receptor 2–negative (HRþ/HER2¯) advanced breast cancer (ABC) were randomized 2:1 to receive palbociclib (125 mg orally/day; 3/1 week schedule) and fulvestrant (500 mg intramuscularly) or placebo and fulvestrant. This OS analysis was performed when 75% of enrolled patients died (393 events in 521 randomized patients). ctDNA analysis was performed among patients who provided consent. Results: At the data cutoff (August 17, 2020), 258 and 135 deaths occurred in the palbociclib and placebo groups, respectively. The median OS [95% confidence interval (CI)] was 34.8 months (28.8–39.9) in the palbociclib group and 28.0 months (23.5–33.8) in the placebo group (stratified hazard ratio, 0.81; 95% CI, 0.65–0.99). The 6-year OS rate (95% CI) was 19.1% (14.9–23.7) and 12.9% (8.0–19.1) in the palbociclib and placebo groups, respectively. Favorable OS with palbociclib plus fulvestrant compared with placebo plus fulvestrant was observed in most subgroups, particularly in patients with endocrine-sensitive disease, no prior chemotherapy for ABC and low circulating tumor fraction and regardless of ESR1, PIK3CA, or TP53 mutation status. No new safety signals were identified. Conclusions: The clinically meaningful improvement in OS associated with palbociclib plus fulvestrant was maintained with >6 years of follow-up in patients with HRþ/HER2¯ABC, supporting palbociclib plus fulvestrant as a standard of care in these patients.

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  43. 周術期化学療法

    増田慎三

    臨牀と研究   ( 8 ) 頁: 969 - 974   2022年8月

  44. Safety and efficacy of nivolumab plus bevacizumab, paclitaxel for HER2-negative metastatic breast cancer: Primary results and biomarker data from a phase 2 trial (WJOG9917B)

    Ozaki Yukinori, Tsurutani Junji, Mukohara Toru, Iwasa Tsutomu, Takahashi Masato, Tanabe Yuko, Kawabata Hidetaka, Masuda Norikazu, Futamura Manabu, Minami Hironobu, Matsumoto Koji, Yoshimura Kenichi, Kitano Shigehisa, Takano Toshimi

    EUROPEAN JOURNAL OF CANCER   171 巻   頁: 193 - 202   2022年8月

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    記述言語:英語   出版者・発行元:European Journal of Cancer  

    Background: Preclinical models revealed potential synergistic effects of programmed cell death-1 inhibitors and anti-vascular endothelial growth factor (VEGF) antibodies. Therefore, we investigated the use of nivolumab, bevacizumab, and paclitaxel triple therapy for metastatic breast cancer. Methods: This phase 2, multicentre, single-arm study (NEWBEAT) investigated the safety and efficacy of first-line nivolumab, paclitaxel, and bevacizumab in patients with human epidermal growth factor receptor 2-negative metastatic breast cancer, regardless of programmed cell death-ligand 1 expression. The primary end-point was objective response rate. Key secondary end-points included progression-free survival, overall survival, and toxicities. A biomarker study evaluated tumour programmed cell death-ligand 1 expression and serum VEGF-A levels. Results: Between February 2018 and October 2018, 57 patients were enrolled. An objective response rate was seen in 39/56 patients (70%, 95% confidence interval [CI]: 55.9–81.2%), meeting the primary end-point. The objective response rate was 74% in patients with hormone receptor-positive breast cancer versus 59% in patients with triple-negative breast cancer. The median progression-free survival and overall survival were 14.0 (95% CI 11.0–16.3) and 32.5 (95% CI 26.0–not evaluable) months, respectively (median follow-up: 29.5 months). Grade 3/4 adverse drug reactions occurred in 33 of 57 patients (58%). There were no grade 5 adverse events. Immune-related adverse events occurred in 43 of 57 patients (75%), with grade 3/4 events in eight patients (14%). Biomarker analysis showed that tumour programmed cell death-ligand 1 expression was not correlated with the efficacy of triple therapy. Efficacy outcomes were similar between the serum VEGF-high and VEGF-low groups. Conclusions: First-line nivolumab, bevacizumab, and paclitaxel therapy showed promising efficacy and manageable toxicity in patients with human epidermal growth factor receptor 2-negative metastatic breast cancer.

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  45. Pembrolizumab plus Chemotherapy in Advanced Triple-Negative Breast Cancer

    Cortes J., Rugo H. S., Cescon D. W., Im S-A, Yusof M. M., Gallardo C., Lipatov O., Barrios C. H., Perez-Garcia J., Iwata H., Masuda N., Otero M. Torregroza, Gokmen E., Loi S., Guo Z., Zhou X., Karantza V, Pan W., Schmid P.

    NEW ENGLAND JOURNAL OF MEDICINE   387 巻 ( 3 ) 頁: 217 - 226   2022年7月

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    記述言語:英語   出版者・発行元:New England Journal of Medicine  

    BACKGROUND In an interim analysis of this phase 3 trial, the addition of pembrolizumab to chemotherapy resulted in longer progression-free survival than chemotherapy alone among patients with advanced triple-negative breast cancer whose tumors expressed programmed death ligand 1 (PD-L1) with a combined positive score (CPS; the number of PD-L1-staining tumor cells, lymphocytes, and macrophages, divided by the total number of viable tumor cells, multiplied by 100) of 10 or more. The results of the final analysis of overall survival have not been reported. METHODS We randomly assigned patients with previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer in a 2:1 ratio to receive pembrolizumab (200 mg) every 3 weeks plus the investigator's choice of chemotherapy (nanoparticle albumin-bound paclitaxel, paclitaxel, or gemcitabine-carboplatin) or placebo plus chemotherapy. The primary end points were progression-free survival (reported previously) and overall survival among patients whose tumors expressed PD-L1 with a CPS of 10 or more (the CPS-10 subgroup), among patients whose tumors expressed PD-L1 with a CPS of 1 or more (the CPS-1 subgroup), and in the intention-to-treat population. Safety was also assessed. RESULTS A total of 847 patients underwent randomization: 566 were assigned to the pembrolizumab-chemotherapy group, and 281 to the placebo-chemotherapy group. The median follow-up was 44.1 months. In the CPS-10 subgroup, the median overall survival was 23.0 months in the pembrolizumab-chemotherapy group and 16.1 months in the placebo-chemotherapy group (hazard ratio for death, 0.73; 95% confidence interval [CI], 0.55 to 0.95; two-sided P=0.0185 [criterion for significance met]); in the CPS-1 subgroup, the median overall survival was 17.6 and 16.0 months in the two groups, respectively (hazard ratio, 0.86; 95% CI, 0.72 to 1.04; two-sided P=0.1125 [not significant]); and in the intention-to-treat population, the median overall survival was 17.2 and 15.5 months, respectively (hazard ratio, 0.89; 95% CI, 0.76 to 1.05 [significance not tested]). Adverse events of grade 3, 4, or 5 that were related to the trial regimen occurred in 68.1% of the patients in the pembrolizumab-chemotherapy group and in 66.9% in the placebo-chemotherapy group, including death in 0.4% of the patients in the pembrolizumab-chemotherapy group and in no patients in the placebo-chemotherapy group. CONCLUSIONS Among patients with advanced triple-negative breast cancer whose tumors expressed PD-L1 with a CPS of 10 or more, the addition of pembrolizumab to chemotherapy resulted in significantly longer overall survival than chemotherapy alone.

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  46. A Japanese prospective multi-institutional feasibility study on accelerated partial breast irradiation using multicatheter interstitial brachytherapy: clinical results with a median follow-up of 60 months 査読有り

    Yoshida Ken, Nose Takayuki, Otani Yuki, Asahi Shuuji, Tsukiyama Iwao, Dokiya Takushi, Saeki Toshiaki, Fukuda Ichirou, Sekine Hiroshi, Kumazaki Yu, Takahashi Takao, Kotsuma Tadayuki, Masuda Norikazu, Yoden Eisaku, Nakashima Kazutaka, Matsumura Taisei, Nakagawa Shino, Tachiiri Seiji, Moriguchi Yoshio, Itami Jun, Oguchi Masahiko

    BREAST CANCER   29 巻 ( 4 ) 頁: 636 - 644   2022年7月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Breast Cancer  

    Background: We carried out the first multi-institutional prospective study on accelerated partial breast irradiation (APBI) via multicatheter interstitial brachytherapy in a shorter period for early breast cancer in Japan. Methods: Patient eligibility criteria included positive hormone receptors, tumors ≤ 3 cm and TNM stage pN0M0. After breast-conserving surgery (Japanese cylindrical resection) and histological confirmation of negative surgical margins and the absence of lymph node metastasis, applicator implantation was performed either postoperatively or intraoperatively. High-dose-rate brachytherapy of 36 Gy in 6 fractions was delivered. Results: Forty-six patients from six institutions received this treatment regimen, and the median follow-up time was 60 months (range 57–67 months). The median resected breast tissue volume was 81 cm3 (range 28–260 cm3). No Grade 4 late sequela, local recurrence nor death due to breast cancer were observed. Grade 2–3 sequelae such as rib fracture (2%), soft tissue necrosis (9%), fibrosis (20%), and breast pain (9%) were observed. The resected breast tissue volumes of the patients who had Grade ≥ 2 fibrosis and Grade < 2 fibrosis were 105.9 ± 32.3 cm3 and 76.3 ± 45.6 cm3, respectively, p = 0.02. The overall cosmetic outcome score of Excellent/Good was 74% at 60 months after APBI. Grade ≥ 1 fibrosis was observed in 44% and 92% of patients who scored Excellent/Good and Fair/Poor, respectively, p = 0.004. Conclusions: This study showed excellent local control and survival results with minimal late sequelae.

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  47. Validation of a nuclear grading system for resected stage I-IIIA, high-risk, node-negative invasive breast carcinoma in the N.SAS-BC 01 trial (Apr, 10.1007/s12282-022-01350-4, 2022)

    Tsuda Hitoshi, Kurosumi Masafumi, Akiyama Futoshi, Ohno Shinji, Saji Shigehira, Masuda Norikazu, Shimomura Akihiko, Sato Nobuaki, Takao Shintaro, Ohsumi Shozo, Tokuda Yutaka, Inaji Hideo, Watanabe Toru

    BREAST CANCER   29 巻 ( 4 ) 頁: 730 - 730   2022年7月

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    記述言語:英語   出版者・発行元:Breast Cancer  

    In the original publication of the article, the affiliation of the co-author, Norikazu Masuda, should be changed from “National Hospital Organization Osaka National Hospital, Osaka, Japan” to “Nagoya University Graduate School of Medicine, Nagoya, Japan”.

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  48. KEYNOTE-355 Asian subset: Pembrolizumab plus chemotherapy vs placebo plus chemotherapy for triple-negative breast cancer

    Takano Toshimi, Cortes Javier, Cescon David W., Im Seock-Ah, Yusof Mastura Md, Iwata Hiroji, Masuda Norikazu, Huang Chiun-Sheng, Chung Chi-Feng, Tsugawa Koichiro, Park Yeon Hee, Matsumoto Koji, Inoue Kenichi, Kwong Ava, Loi Sherene, Fu Wei, Pan Wilbur, Karantza Valia, Rugo Hope S., Schmid Peter

    ANNALS OF ONCOLOGY   33 巻   頁: S465 - S465   2022年7月

  49. Validation of a nuclear grading system for resected stage I–IIIA, high‑risk, node‑negative invasive breast carcinoma in the N·SAS‑BC 01 trial

    Tsuda H,Kurosumi M,Akiyama F,Ohno S,Saji S,Masuda N,Shimomura A,SatoN,Takao S,Ohsumi S,Tokuda Y,Inaji H,Watanabe T

    Breast Cancer   29 巻 ( 4 ) 頁: 720 - 729   2022年7月

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    出版者・発行元:Breast Cancer  

    Background: This retrospective observational study validated nuclear grading criteria developed to identify a high-risk group with recurrence rate ≥20-30% and local pathology diagnosis used in a previous multi-institutional randomized N·SAS-BC 01 trial, where the efficacy of adjuvant chemotherapy regimens was evaluated in 733 high-risk node-negative invasive breast cancer patients.Methods: Of 545 patients with long-term follow-up data (median 12.1 years), pathology slides, and local pathology diagnosis, 530 eligible patients were subjected to central pathology review (CPR) for histological type and nuclear grade (NG). Concordance in NGs was compared with local diagnosis. The 10/15-year recurrence-free survival (RFS) and overall survival (OS) rates stratified by NG and histological type were calculated.Results: Local diagnoses were invasive ductal carcinoma (IDC)-NG2, IDC-NG3, invasive lobular carcinoma (ILC), and metaplastic carcinoma (MC) in 158/327/38/7 patients, respectively. The 10/15-year RFS rates were 87.2/82.6% for IDC-NG2 and 81.8/75.0% for IDC-NG3 (p = 0.061), and OS rates were 95.0/92.8% for IDC-NG2 and 90.8/85.7% for IDC-NG3 (p = 0.042). CPR graded 485 locally diagnosed IDCs as IDC-NG1/NG2/NG3/unknown in 98/116/267/4 patients, respectively. No significant difference was found among survival curves for the three NG groups. Although the agreement level between local and CPR diagnoses was low (κ = 0.311), both diagnoses identified a patient group with a 15-year recurrence rate ≥ 20%. The 10/15-year RFS rates were 79.4/63.5% for ILC and 68.6%/unknown for MC.Conclusions: The N·SAS grading system identified a patient group with high-risk node-negative invasive breast cancer, suggesting that local diagnosis was performed efficiently in the N·SAS-BC 01 trial.Trial registration number: UMIN000022571. Date of registration: June 1, 2016.

    DOI: 10.1007/s12282-022-01350-4

  50. Observational study of axilla treatment for breast cancer patients with 1 to 3 positive micrometastases or macrometastases in sentinel lymph nodes.

    Yasojima Hiroyuki, Imoto Shigeru, Nagashima Takeshi, Onishi Tatsuya, Takashima Tsutomu, Kitada Masahiro, Kawada Masaya, Hayashida Tetsu, Naoi Yasuto, Aihara Tomohiko, Wada Noriaki, Kawabata Hidetaka, Yoshida Masayuki, Toh Uhi, Yoneyama Kimiyasu, Yamada Akimitsu, Tsuda Hitoshi, Masuda Norikazu, Saito-Oba Mari, Sakamoto Junichi

    JOURNAL OF CLINICAL ONCOLOGY   40 巻 ( 16 )   2022年6月

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  51. Results from the phase 1/2 study of patritumab deruxtecan, a HER3-directed antibody-drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC).

    Krop Ian E, Masuda Norikazu, Mukohara Toru, Takahashi Shunji, Nakayama Takahiro, Inoue Kenichi, Iwata Hiroji, Toyama Tatsuya, Yamamoto Yutaka, Hansra Damien Mikael, Takahashi Masato, Osaki Akihiko, Koyama Kumiko, Inoue Tatsuya, Yonekura Takatoshi, Mostillo Joseph, Ohwada Shoichi, Tanaka Yoshimi, Sternberg David W, Yonemori Kan

    JOURNAL OF CLINICAL ONCOLOGY   40 巻 ( 16 )   2022年6月

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  52. Observational study of axilla treatment for breast cancer patients with 1 to 3 positive micrometastases or macrometastases in sentinel lymph nodes.

    Yasojima Hiroyuki, Imoto Shigeru, Nagashima Takeshi, Onishi Tatsuya, Takashima Tsutomu, Kitada Masahiro, Kawada Masaya, Hayashida Tetsu, Naoi Yasuto, Aihara Tomohiko, Wada Noriaki, Kawabata Hidetaka, Yoshida Masayuki, Toh Uhi, Yoneyama Kimiyasu, Yamada Akimitsu, Tsuda Hitoshi, Masuda Norikazu, Saito-Oba Mari, Sakamoto Junichi

    JOURNAL OF CLINICAL ONCOLOGY   40 巻 ( 16 )   2022年6月

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  53. Results from the phase 1/2 study of patritumab deruxtecan, a HER3-directed antibody-drug conjugate (ADC), in patients with HER3-expressing metastatic breast cancer (MBC).

    Krop Ian E., Masuda Norikazu, Mukohara Toru, Takahashi Shunji, Nakayama Takahiro, Inoue Kenichi, Iwata Hiroji, Toyama Tatsuya, Yamamoto Yutaka, Hansra Damien Mikael, Takahashi Masato, Osaki Akihiko, Koyama Kumiko, Inoue Tatsuya, Yonekura Takatoshi, Mostillo Joseph, Ohwada Shoichi, Tanaka Yoshimi, Sternberg David W., Yonemori Kan

    JOURNAL OF CLINICAL ONCOLOGY   40 巻 ( 16 )   2022年6月

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  54. Phase 1 study of the liposomal formulation of eribulin (E7389-LF): Results from the breast cancer expansion cohort

    Masuda Norikazu, Ono Makiko, Mukohara Toru, Yasojima Hiroyuki, Shimoi Tatsunori, Kobayashi Kokoro, Harano Kenichi, Mizutani Makiko, Tanioka Maki, Takahashi Shunji, Kogawa Takahiro, Suzuki Takuya, Okumura Shiori, Takase Takao, Nagai Reiko, Semba Taro, Zhao Zi-Ming, Ren Min, Yonemori Kan

    EUROPEAN JOURNAL OF CANCER   168 巻   頁: 108 - 118   2022年6月

  55. 新時代を迎えた乳癌術前薬物療法

    増田慎三

    現代医学   69 巻 ( 1 ) 頁: 50 - 56   2022年6月

  56. Health-related quality of life (HRQoL) with pembrolizumab (pembro) plus chemotherapy (chemo) vs placebo (pbo) + chemo as 1L treatment for advanced triple-negative breast cancer (TNBC): Results from KEYNOTE-355

    Cescon D. W., Schmid P., Rugo H. S., Im S-A., Yusof M. Md, Gallardo C. E., Lipatov O., Barrios C. H., Perez Garcia J. M., Iwata H., Masuda N., Torregroza Otero M. A., Gokmen E., Loi S., Haiderali A., Zhou X., Guo Z., Nguyen A. Martin, Cortes J.

    ANNALS OF ONCOLOGY   33 巻   頁: S197 - S198   2022年5月

  57. 新たな時代を迎える専門医制度

    石田孝宣,石川孝,増田慎三,井本滋

    乳癌の臨床   37 巻 ( 2 ) 頁: 139 - 150   2022年5月

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    出版者・発行元:篠原出版新社  

  58. Switch maintenance endocrine therapy plus bevacizumab after bevacizumab plus paclitaxel in advanced or metastatic oestrogen receptor-positive, HER2-negative breast cancer (BOOSTER): a randomised, open-label, phase 2 trial

    Saji Shigehira, Taira Naruto, Kitada Masahiro, Takano Toshimi, Takada Masahiro, Ohtake Tohru, Toyama Tatsuya, Kikawa Yuichiro, Hasegawa Yoshie, Fujisawa Tomomi, Kashiwaba Masahiro, Ishida Takanori, Nakamura Rikiya, Yamamoto Yutaka, Toh Uhi, Iwata Hiroji, Masuda Norikazu, Morita Satoshi, Ohno Shinji, Toi Masakazu

    LANCET ONCOLOGY   23 巻 ( 5 ) 頁: 636 - 649   2022年5月

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    記述言語:英語   出版者・発行元:The Lancet Oncology  

    Background: Anticancer treatment regimens typically cause unpleasant side-effects. We aimed to investigate the benefit of switch maintenance endocrine therapy plus bevacizumab after fixed cycles of first-line induction chemotherapy with weekly paclitaxel plus bevacizumab in patients with oestrogen receptor (ER)-positive, HER2-negative advanced or metastatic breast cancer. Methods: BOOSTER was a prospective, open-label, multicentre, randomised, controlled, phase 2 study done in 53 hospitals in Japan. Eligible patients were women aged 20–75 years, with an Eastern Cooperative Oncology Group performance status of 0–1, who had not received chemotherapy for ER-positive, HER2-negative advanced or metastatic breast cancer. All patients received four to six cycles (in which 4 weeks of treatment constitute one cycle) of weekly paclitaxel plus bevacizumab induction therapy (weekly paclitaxel 90 mg/m2, administered intravenously on days 1, 8, and 15 of each cycle, plus bevacizumab 10 mg/kg administered intravenously on days 1 and 15 of each cycle; first registration). Patients with a complete response, partial response, or stable disease after induction therapy (responders) were then randomly assigned (1:1) using the randomisation enrolment form to either continue weekly paclitaxel plus bevacizumab or switch to maintenance endocrine therapy (an aromatase inhibitor or fulvestrant with or without ovarian-function suppression) plus bevacizumab. Randomisation was stratified by induction therapy period, response to induction therapy, age, history of endocrine therapy, and study site. Patients could receive weekly paclitaxel plus bevacizumab reinduction if they had disease progression with maintenance endocrine therapy plus bevacizumab. The primary endpoint was time to failure of strategy (TFS). Efficacy and safety analyses were done in all treated patients (full analysis set). This study is registered with ClinicalTrials.gov, NCT01989780, and registration and follow-up are closed. Findings: Between Jan 1, 2014, and Dec 31, 2015, we enrolled 160 patients who began weekly paclitaxel plus bevacizumab induction therapy. 125 (78%) patients (responders) were randomly assigned to endocrine therapy plus bevacizumab (n=62; n=61 in the full analysis set) or weekly paclitaxel plus bevacizumab (n=63; n=63 in the full analysis set). Among 61 patients in the switch maintenance endocrine therapy plus bevacizumab group, 32 (52%) were reinitiated on weekly paclitaxel plus bevacizumab. At a median follow-up of 21·3 months (IQR 13·0–28·2), TFS was significantly longer in the endocrine therapy plus bevacizumab group than in the weekly paclitaxel plus bevacizumab group (median 16·8 months [95% CI 12·9–19·0] vs 8·9 months [5·7–13·8]; hazard ratio 0·51 [0·34–0·75]; p=0·0006). The most common grade 3–4 non-haematological adverse events after randomisation were proteinuria (in ten [16%] of 61 patients in the endocrine therapy plus bevacizumab group vs eight [13%] of 63 patients in the weekly paclitaxel plus bevacizumab group), hypertension (six [10%] vs six [10%]), and peripheral neuropathy (one [2%] vs six [10%]). One treatment-related death was reported in the weekly paclitaxel plus bevacizumab group (duodenal ulcer perforation). Interpretation: Switch to maintenance endocrine therapy plus bevacizumab with the possibility of weekly paclitaxel reinduction if needed is an efficacious alternative, with a better safety profile, to continuing weekly paclitaxel plus bevacizumab in patients with ER-positive, HER2-negative advanced or metastatic breast cancer who have responded to induction therapy. Funding: Chugai Pharmaceutical. Translation: For the Japanese translation of the abstract see Supplementary Materials section.

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  59. Immune microenvironment, homologous recombination deficiency, and therapeutic response to neoadjuvant chemotherapy in triple-negative breast cancer: Japan Breast Cancer Research Group (JBCRG)22 TR

    Ueno Takayuki, Kitano Shigehisa, Masuda Norikazu, Ikarashi Daiki, Yamashita Makiko, Chiba Tomohiro, Kadoya Takayuki, Bando Hiroko, Yamanaka Takashi, Ohtani Shoichiro, Nagai Shigenori, Nakayama Takahiro, Takahashi Masato, Saji Shigehira, Aogi Kenjiro, Velaga Ravi, Kawaguchi Kosuke, Morita Satoshi, Haga Hironori, Ohno Shinji, Toi Masakazu

    BMC MEDICINE   20 巻 ( 1 ) 頁: 136   2022年4月

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    記述言語:英語   出版者・発行元:BMC Medicine  

    Background: Triple-negative breast cancer (TNBC) is a biologically diverse disease, with characteristics such as homologous recombination deficiency (HRD), gene mutation, and immune reactions. Japan Breast Cancer Research Group 22 is a multicenter trial examining TNBC’s response to neoadjuvant chemotherapy (NAC) according to the HRD status. This translational research investigated the clinical significance of the immune microenvironment of TNBC in association with HRD, tumor BRCA1/2 (tBRCA1/2) mutation, and response to NAC. Methods: Patients aged below 65 years with high HRD or germline BRCA1/2 (gBRCA1/2) mutation randomly received paclitaxel + carboplatin (group A1) or eribulin + carboplatin (A2), followed by anthracycline. Patients aged below 65 years with low HRD or those aged 65 years or older without gBRCA1/2 mutation randomly received eribulin + cyclophosphamide (B1) or eribulin + capecitabine (B2); nonresponders to the first four cycles of the therapy received anthracycline. A pathological complete response (pCR) was defined as the absence of residual cancer cells in the tissues. Pretreatment biopsy specimens were stained by multiplexed fluorescent immunohistochemistry using antibodies against CD3, CD4, CD8, Foxp3, CD204, and pan-cytokeratin. Immune cells with specific phenotypes were counted per mm2 in cancer cell nests (intratumor) and stromal regions. The immune cell densities were compared with clinicopathological and genetic factors including tumor response. Results: This study analyzed 66 samples. T1 tumors had a significantly higher density of intratumoral CD8+ T cells than T2 or larger tumors. The tBRCA1/2 mutation or HRD status was not associated with the density of any immune cell. The density of intratumoral and stromal CD4+ T cells was higher in patients showing pCR than in those without pCR. In a multivariate analysis, intratumoral and stromal CD4+ T cell density significantly predicted pCR independent of age, chemotherapy dose, HRD status, and treatment groups (P = 0.009 and 0.0057, respectively). In a subgroup analysis, the predictive value of intratumoral and stromal CD4+ T cell density persisted in the platinum-containing chemotherapy group (A1+A2) but not in the non-platinum-containing group (B1+B2). Conclusions: Intratumoral and stromal CD4+ T cell density was an independent predictor of pCR in patients with TNBC. A larger study is warranted to confirm the results. Trial registration: UMIN000023162.

    DOI: 10.1186/s12916-022-02332-1

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  60. Factors associated with overall survival after recurrence in patients with ER-positive/HER2-negative postmenopausal breast cancer: an ad hoc analysis of the JBCRG-C06 Safari study. 査読有り

    Kawaguchi H, Yamamoto Y, Saji S, Masuda N, Nakayama T, Aogi K, Anan K, Ito Y, Ohtani S, Sato N, Takano T, Tokunaga E, Nakamura S, Hasegawa Y, Hattori M, Fujisawa T, Morita S, Yamaguchi M, Yamashita H, Yamashita T, Yotsumoto D, Toi M, Ohno S

    Japanese journal of clinical oncology     2022年3月

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    記述言語:英語  

    DOI: 10.1093/jjco/hyac022

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  61. Effect of proximal optimization technique on coronary bifurcation stent failure: Insights from the multicenter randomized PROPOT trial

    Murasato Y, Watanabe Y, Yamawaki M, Kinoshita Y, Okubo M, Yumoto K, Masuda N, Otake H, Aoki J, Nakazawa G, Numasawa Y, Ito T, Shite J, Okamura T, Takagi K, Kozuma K, Lefèvre T, Chevalier B, Louvard Y, Suzuki N, Kozuma K

    Catheterization and Cardiovascular Interventions   99 巻 ( 4 ) 頁: 1047 - 1058   2022年3月

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    出版者・発行元:Catheterization and Cardiovascular Interventions  

    Objective: We investigated the effect of proximal optimization technique (POT) on coronary bifurcation stent failure (BSF) in cross-over stenting by comparing with the kissing balloon technique (KBT) in a multicenter randomized PROPOT trial. Background: POT is recommended due to increased certainty for optimal stent expansion and side branch (SB) wiring. Methods: We randomized 120 patients treated with crossover stenting into the POT group, which was followed by SB dilation (SBD), and the KBT group. Finally, 52 and 57 patients were analyzed by optical coherence tomography before SBD and at the final procedure, respectively. Composite BSF was defined as a maximal malapposition distance of >400 μm, or malapposed and SB-jailed strut rates of >5.95% and >21.4%, respectively. Results: Composite BSF before SBD in the POT and KBT groups was observed in 29% and 26% of patients, respectively. In the POT group, differences in stent volumetric index between the proximal and distal bifurcation (odds ratio [OR] 60.35, 95% confidential interval [CI] 0.13–0.93, p = 0.036) and between the proximal bifurcation and bifurcation core (OR: 3.68, 95% CI: 1.01–13.40, p = 0.048) were identified as independent risk factors. Composite BSF at final in 27% and 32%, and unplanned additional procedures in 38% and 25% were observed, respectively. Composite BSF before SBD was a risk factor for the former (OR: 6.33, 95% CI: 1.10–36.50, p = 0.039) and the latter (OR: 6.43, 95% CI: 1.25–33.10, p = 0.026) in the POT group. Conclusion: POT did not result in a favorable trend in BSF. Insufficient expansion of the bifurcation core after POT was associated with BSF.

    DOI: 10.1002/ccd.30120

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  62. Multicenter Randomized Open-Label Phase II Clinical Study Comparing Outcomes of NK105 and Paclitaxel in Advanced or Recurrent Breast Cancer

    Kosaka Yoshimasa, Saeki Toshiaki, Takano Toshimi, Aruga Tomoyuki, Yamashita Toshinari, Masuda Norikazu, Koibuchi Yukio, Osaki Akihiko, Watanabe Junichiro, Suzuki Ryu

    INTERNATIONAL JOURNAL OF NANOMEDICINE   17 巻   頁: 4567 - 4578   2022年

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    記述言語:英語   出版者・発行元:International Journal of Nanomedicine  

    Background: NK105 is a paclitaxel (PTX)-incorporating “core-shell-type” polymeric micellar nanoparticle formulation composed of block copolymers (polyethylene glycol and a polyamino acid). The efficacy and safety of NK105 and paclitaxel in advanced or recurrent breast cancer have never been compared at equivalent dose levels. Patients and Methods: Patients were randomly assigned to either NK105 or PTX in a 1:1 ratio. The study drug was administered on Day 1, 8, and 15 of a 28-day cycle with 80 mg/m2. The primary endpoint was overall response rate (ORR), secondary endpoints were progression-free survival (PFS), overall survival (OS), and adverse events. Results: A total of 123 patients (NK105, n=62; PTX, n=61) received one of the two drugs. There was no significant difference in ORR, the median PFS, or OS (NK105 group: 41.9%, 9.1, and 27.5 months, respectively; PTX group: 45.9%, 7.8, and 32.4 months, respectively). Neutropenia occurred more frequently in the NK105 group, but most patients did not require granulocyte-colony stimulating factor or dose-reduction. The median time to onset of peripheral sensory neuropathy (PSN) in the NK105 group was significantly longer than that in the PTX group (p=0.001), and PSN (≥ grade 3) was not observed in the NK105 group. Conclusion: Weekly NK105 administration was well-tolerated. Efficacy was similar in both groups. The PSN profile was better in the NK105 group.

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  63. Safety in Japanese Advanced Breast Cancer Patients Who Received Abemaciclib in MONARCH 2 and MONARCH 3: Assessment of Treatment-Emergent Neutropenia, Diarrhea, and Increased Alanine Aminotransferase and Aspartate Aminotransferase Levels

    Masuda Norikazu, Chen Yucherng, Kawaguchi Tsutomu, Dozono Koji, Toi Masakazu

    CANCER MANAGEMENT AND RESEARCH   14 巻   頁: 1179 - 1194   2022年

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    記述言語:英語   出版者・発行元:Cancer Management and Research  

    Purpose: Our objective was to gain a better understanding of the safety of abemaciclib in Japanese patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Patients and Methods: Treatment-emergent adverse events (TEAEs) were assessed in pooled Japanese subpopulation data from two phase 3 studies assessing abemaciclib/placebo in combination with fulvestrant (MONARCH 2; M2) or non-steroidal aromatase inhibitors (MONARCH 3; M3). For common, clinically relevant TEAEs, event characteristics and management were summarized by study. Results: In the Japanese safety subpopulation (abemaciclib: N=101; placebo: N=46), all patients experienced ≥1 TEAE (Grade ≥ 3: abemaciclib, 71.3%; placebo, 23.9%; no Grade 5). Clinically relevant TEAEs that were more frequent in abemaciclib-treated Japanese patients compared to the overall safety populations included diarrhea (any grade, 95.0%; Grade ≥ 3, 12.9%), neutropenia (any grade, 75.2%; Grade 3–4, 35.6%), increased alanine aminotransferase (ALT; any grade, 39.6%; Grade 3–4, 14.9%), and increased aspartate aminotransferase (AST; any grade, 37.6%; Grade 3–4, 8.9%). Diarrhea was Grade ≤3 and successfully managed with medications (≥87%) and dose reductions (≤25%) and/ or omissions (≤23.3%). Most Grade ≥2 diarrhea occurred in the first treatment cycle, declining thereafter. Neutropenia, the most common Grade ≥3 TEAE in abemaciclib-treated Japanese patients, was generally manageable with dose omissions (M2: 42.0%; M3: 23.1%) and/or reductions (M2: 16%; M3: 15.4%). Neutrophil counts plateaued after Cycle 2, recovering to pretreatment levels after discontinuation of abemaciclib. Hepatic events were managed with medication (≤21%) and dose adjustments (≤33.3%), with most Grade ≥2 events occurring in early treatment cycles. Discontinuation of any study treatment in Japanese patients occurred more frequently due to increased ALT/AST (M2: 9.1%/10.5%; M3: 16.7%/10.5%) compared with diarrhea (M2: 0%; M3: 2.8%) or neutropenia (M2: 0%; M3: 3.8%). Conclusion: Abemaciclib was well tolerated in Japanese patients in MONARCH 2 and MONARCH 3, with common, clinically relevant TEAEs manageable with appropriate interventions.

    DOI: 10.2147/CMAR.S348591

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  64. A phase II study of sequential treatment with anthracycline and taxane followed by eribulin in patients with HER2-negative, locally advanced breast cancer (JBCRG-17)

    Fukada I, Ito Y, Kondo N, Ohtani S, Hattori M, Tokunaga E, Matsunami N, Mashino K, Kosaka T, Tanabe M, Yotsumoto D, Yamanouchi K, Sawaki M, Kashiwaba M, Kawabata H, Kuroi K, Morita S, Ohno S, Toi M, Masuda N

    Breast Cancer Research and Treatment   190 巻 ( 3 ) 頁: 425 - 434   2021年12月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Breast Cancer Research and Treatment  

    Purpose: The sequence of taxanes (T) followed by anthracyclines (A) as neoadjuvant chemotherapy has been the standard of care for almost 20 years for locally advanced breast cancer (LABC). Sequential administration of eribulin (E) following A/T could provide a greater response rate for women with LABC. Methods: In this single-arm, multicenter, Phase II prospective study, the patients received 4 cycles of the FEC regimen and 4 cycles of taxane. After the A/T-regimen, 4 cycles of E were administered followed by surgical resection. The primary endpoint was the clinical response rate. Eligible patients were women aged 20 years or older, with histologically confirmed invasive breast cancer, clinical Stage IIIA (T2–3 and N2 only), Stage IIIB, and Stage IIIC, HER2-negative. Results: A preplanned interim analysis aimed to validate the trial assumptions was conducted after treatment of 20 patients and demonstrated that clinical progressive disease rates in the E phase were significantly higher (30%) than assumed. Therefore, the Independent Data Monitoring Committee recommended stopping the study. Finally, 53 patients were enrolled, and 26 patients received the A/T/E-regimen. The overall observed clinical response rate (RR) was 73% (19/26); RRs were 77% (20/26) in the AT phase and 23% (6/26) in the E phase. Thirty percent (8/26) of patients had PD in the E phase, 6 of whom had achieved cCR/PR in the AT phase. Reported grade ≥ 3 AEs related to E were neutropenia (42%), white blood cell count decrease (27%), febrile neutropenia (7.6%), weight gain (3.8%), and weight loss (3.8%). Conclusion: Sequential administration of eribulin after the A/T-regimen provided no additional effect for LABC patients. Future research should continue to focus on identifying specific molecular biomarkers that can improve response rates.

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  65. [Development of CDK4 & 6 Inhibitor Abemaciclib in Breast Cancer]. 査読有り

    Masuda N, Saji S, Kawaguchi T, Chen Y, Ohno S

    Gan to kagaku ryoho. Cancer & chemotherapy   48 巻 ( 12 ) 頁: 1475 - 1483   2021年12月

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    記述言語:日本語  

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  66. [Development of CDK4 & 6 Inhibitor Abemaciclib in Breast Cancer]. 査読有り

    Masuda N, Saji S, Kawaguchi T, Chen Y, Ohno S

    Gan to kagaku ryoho. Cancer & chemotherapy   48 巻 ( 12 ) 頁: 1475 - 1483   2021年12月

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    記述言語:日本語  

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  67. MONARCH 2: Subgroup Analysis of Patients Receiving Abemaciclib Plus Fulvestrant as First-Line and Second-Line Therapy for HR<sup>+</sup>, HER2<sup>-</sup>-Advanced Breast Cancer. 査読有り 国際共著

    Neven P, Johnston SRD, Toi M, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Haddad N, Hurt KC, Llombart-Cussac A, Sledge GW

    Clinical cancer research : an official journal of the American Association for Cancer Research   27 巻 ( 21 ) 頁: 5801 - 5809   2021年11月

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    記述言語:英語  

    DOI: 10.1158/1078-0432.CCR-20-4685

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  68. Analysis of the pan-Asian subgroup of patients in the NALA Trial: a randomized phase III NALA Trial comparing neratinib+capecitabine (N+C) vs lapatinib+capecitabine (L+C) in patients with HER2+metastatic breast cancer (mBC) previously treated with two or more HER2-directed regimens. 査読有り 国際共著

    Dai MS, Feng YH, Chen SW, Masuda N, Yau T, Chen ST, Lu YS, Yap YS, Ang PCS, Chu SC, Kwong A, Lee KS, Ow S, Kim SB, Lin J, Chung HC, Ngan R, Kok VC, Rau KM, Sangai T, Ng TY, Tseng LM, Bryce R, Bebchuk J, Chen MC, Hou MF

    Breast cancer research and treatment   189 巻 ( 3 ) 頁: 665 - 676   2021年10月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1007/s10549-021-06313-5

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  69. Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy. 査読有り

    Inoue K, Masuda N, Iwata H, Takahashi M, Ito Y, Miyoshi Y, Nakayama T, Mukai H, van der Walt JS, Mori J, Sakaguchi S, Kawaguchi T, Tanizawa Y, Llombart-Cussac A, Sledge GW Jr, Toi M

    Breast cancer (Tokyo, Japan)   28 巻 ( 5 ) 頁: 1038 - 1050   2021年9月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1007/s12282-021-01239-8

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  70. Meta-analysis of nanoparticle albumin-bound paclitaxel used as neoadjuvant chemotherapy for operable breast cancer based on individual patient data (JBCRG-S01 study). 査読有り

    Futamura M, Oba M, Masuda N, Bando H, Okada M, Yamamoto Y, Kin T, Saeki T, Nagashima T, Kuwayama T, Toh U, Hirano A, Inokuchi M, Yamagami K, Mizuno Y, Kojima Y, Nakayama T, Yasojima H, Ohno S

    Breast cancer (Tokyo, Japan)   28 巻 ( 5 ) 頁: 1023 - 1037   2021年9月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1007/s12282-021-01238-9

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  71. Real-world effectiveness of post-trastuzumab emtansine treatment in patients with HER2-positive, unresectable and/or metastatic breast cancer: a retrospective observational study (KBCSG-TR 1917). 査読有り

    Nakayama T, Yoshinami T, Yasojima H, Kittaka N, Takahashi M, Ohtani S, Kim SJ, Kurakami H, Yamamoto N, Yamada T, Takata T, Masuda N

    BMC cancer   21 巻 ( 1 ) 頁: 795   2021年7月

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    担当区分:最終著者   記述言語:英語   掲載種別:研究論文(学術雑誌)  

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  72. Clinical usefulness of eribulin as first- or second-line chemotherapy for recurrent HER2-negative breast cancer: a randomized phase II study (JBCRG-19). 査読有り

    Aogi K, Watanabe K, Kitada M, Sangai T, Ohtani S, Aruga T, Kawagichi H, Fujisawa T, Maeda S, Morimoto T, Sato N, Takao S, Morita S, Masuda N, Toi M, Ohno S

    International journal of clinical oncology   26 巻 ( 7 ) 頁: 1229 - 1236   2021年7月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1007/s10147-021-01920-0

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  73. Clinicopathological predictors of postoperative upstaging to invasive ductal carcinoma (IDC) in patients preoperatively diagnosed with ductal carcinoma in situ (DCIS): a multi-institutional retrospective cohort study 査読有り

    Tanaka K, Masuda N, Hayashi N, Sagara Y, Hara F, Kadoya T, Matsui A, Miyazaki C, Shien T, Tokunaga E, Hayashi T, Niikura N, Maeda S, Komoike Y, Bando H, Kanbayashi C, Iwata H

    Breast Cancer   28 巻 ( 4 ) 頁: 896 - 903   2021年7月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:Breast Cancer  

    Background: We conducted a prospective study with the intention to omit surgery for patients with ductal carcinoma in situ (DCIS) of the breast. We aimed to identify clinicopathological predictors of postoperative upstaging to invasive ductal carcinoma (IDC) in patients preoperatively diagnosed with DCIS. Patients and methods: We retrospectively analyzed patients with DCIS diagnosed through biopsy between April 1, 2010 and December 31, 2014, from 16 institutions. Clinical, radiological, and histological variables were collected from medical records. Results: We identified 2,293 patients diagnosed with DCIS through biopsy, including 1,663 DCIS (72.5%) cases and 630 IDC (27.5%) cases. In multivariate analysis, the presence of a palpable mass (odds ratio [OR] 1.8; 95% confidence interval [CI] 1.2–2.6), mammography findings (≥ category 4; OR 1.8; 95% CI 1.2–2.6), mass formations on ultrasonography (OR 1.8; 95% CI 1.2–2.5), and tumor size on MRI (> 20 mm; OR 1.7; 95% CI 1.2–2.4) were independent predictors of IDC. Among patients with a tumor size on MRI of ≤ 20 mm, the possibility of postoperative upstaging to IDC was 22.1%. Among the 258 patients with non-palpable mass, nuclear grade 1/2, and positive for estrogen receptor, the possibility was 18.1%, even if the upper limit of the tumor size on MRI was raised to ≤ 40 mm. Conclusion: We identified four independent predictive factors of upstaging to IDC after surgery among patients with DCIS diagnosed by biopsy. The combined use of various predictors of IDC reduces the possibility of postoperative upstaging to IDC, even if the tumor size on MRI is larger than 20 mm.

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  74. Correction to: Clinical usefulness of eribulin as first- or second-line chemotherapy for recurrent HER2-negative breast cancer: a randomized phase II study (JBCRG-19).

    Aogi K, Watanabe K, Kitada M, Sangai T, Ohtani S, Aruga T, Kawagichi H, Fujisawa T, Maeda S, Morimoto T, Sato N, Takao S, Morita S, Masuda N, Toi M, Ohno S

    International journal of clinical oncology   26 巻 ( 7 ) 頁: 1237   2021年7月

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    DOI: 10.1007/s10147-021-01940-w

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  75. In Reply.

    Rugo HS, Huober J, Garcia-Saenz JA, Masuda N, Sohn JH, Andre VAM, Barriga S, Cox J, Goetz M

    The oncologist   26 巻 ( 7 ) 頁: e1286 - e1287   2021年7月

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    DOI: 10.1002/onco.13782

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  76. Patient-Reported Outcomes in Patients With <i>PIK3CA</i>-Mutated Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer From SOLAR-1. 査読有り 国際共著

    Ciruelos EM, Rugo HS, Mayer IA, Levy C, Forget F, Delgado Mingorance JI, Safra T, Masuda N, Park YH, Juric D, Conte P, Campone M, Loibl S, Iwata H, Zhou X, Park J, Ridolfi A, Lorenzo I, André F

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology   39 巻 ( 18 ) 頁: 2005 - 2015   2021年6月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1200/JCO.20.01139

    PubMed

  77. Abemaciclib in combination with endocrine therapy for East Asian patients with HR+, HER2- advanced breast cancer: MONARCH 2 & MONARCH 3 trials. 査読有り 国際共著

    Toi M, Inoue K, Masuda N, Iwata H, Sohn J, Hae Park I, Im SA, Chen SC, Enatsu S, Turner PK, André VAM, Hardebeck MC, Sakaguchi S, Goetz MP, Sledge GW Jr

    Cancer science   112 巻 ( 6 ) 頁: 2381 - 2392   2021年6月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1111/cas.14877

    PubMed

  78. Analysis of subsequent therapy in Japanese patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer who received palbociclib plus endocrine therapy in PALOMA-2 and -3. 査読有り

    Masuda N, Mukai H, Inoue K, Rai Y, Ohno S, Ohtani S, Shimizu C, Hashigaki S, Muramatsu Y, Umeyama Y, Iwata H, Toi M

    Breast cancer (Tokyo, Japan)   28 巻 ( 2 ) 頁: 335 - 345   2021年3月

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    担当区分:筆頭著者   記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1007/s12282-020-01162-4

    PubMed

  79. Management of Abemaciclib-Associated Adverse Events in Patients with Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Safety Analysis of MONARCH 2 and MONARCH 3. 査読有り 国際共著

    Rugo HS, Huober J, García-Sáenz JA, Masuda N, Sohn JH, Andre VAM, Barriga S, Cox J, Goetz M

    The oncologist   26 巻 ( 3 ) 頁: e522   2021年3月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1002/onco.13691

    PubMed

  80. Efficacy of the eribulin, pertuzumab, and trastuzumab combination therapy for human epidermal growth factor receptor 2-positive advanced or metastatic breast cancer: a multicenter, single arm, phase II study (JBCRG-M03 study). 査読有り

    Yamashita T, Kawaguchi H, Masuda N, Kitada M, Narui K, Hattori M, Yoshinami T, Matsunami N, Yanagihara K, Kawasoe T, Nagashima T, Bando H, Yano H, Hasegawa Y, Nakamura R, Kashiwaba M, Morita S, Ohno S, Toi M

    Investigational new drugs   39 巻 ( 1 ) 頁: 217 - 225   2021年2月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1007/s10637-020-00991-6

    PubMed

  81. Rechallenge of anti-PD-1/PD-L1 antibody showed a good response to metastatic breast cancer: a case report. 査読有り

    Otani Y, Mori K, Morikawa N, Mizutani M, Yasojima H, Masuyama M, Mano M, Masuda N

    Immunotherapy   13 巻 ( 3 ) 頁: 189 - 194   2021年2月

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    担当区分:最終著者   記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.2217/imt-2020-0242

    PubMed

  82. Relationships between pathological factors and long-term outcomes in patients enrolled in two prospective randomized controlled trials comparing the efficacy of oral tegafur-uracil with CMF (N·SAS-BC 01 trial and CUBC trial). 査読有り

    Ohno S, Saji S, Masuda N, Tsuda H, Akiyama F, Kurosumi M, Shimomura A, Sato N, Takao S, Ohsumi S, Tokuda Y, Inaji H, Watanabe T, Ohashi Y

    Breast cancer research and treatment   186 巻 ( 1 ) 頁: 135 - 147   2021年2月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1007/s10549-020-06018-1

    PubMed

  83. Adjuvant S-1 plus endocrine therapy for oestrogen receptor-positive, HER2-negative, primary breast cancer: a multicentre, open-label, randomised, controlled, phase 3 trial 査読有り

    Toi M, Imoto S, Ishida T, Ito Y, Iwata H, Masuda N, Mukai H, Saji S, Shimizu A, Ikeda T, Haga H, Saeki T, Aogi K, Sugie T, Ueno T, Kinoshita T, Kai Y, Kitada M, Sato Y, Jimbo K, Sato N, Ishiguro H, Takada M, Ohashi Y, Ohno S

    The Lancet Oncology   22 巻 ( 1 ) 頁: 74 - 84   2021年1月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)   出版者・発行元:The Lancet Oncology  

    Background: Oral fluoropyrimidines, such as S-1, have been shown to have a role in controlling disease progression in metastatic breast cancer. We examined adjuvant treatment with S-1 in patients with oestrogen receptor (ER)-positive and HER2-negative primary breast cancer. Methods: We did a multicentre, open-label, randomised, controlled, phase 3 trial in 139 sites (137 hospitals and two clinics). Eligible patients were women aged 20–75 years with histologically diagnosed stage I to IIIB invasive breast cancer (intermediate to high risk of recurrence). Patients were temporarily registered at participating institutions and biopsy or surgical samples were collected and sent for central pathological assessment. Patients received 5 years of standard adjuvant endocrine therapy (selective oestrogen receptor modulators with or without ovarian suppression and aromatase inhibitors) with or without 1 year of S-1. Oral S-1 80–120 mg/day was administered twice a day for 14 days with 7 days off. Randomisation (1:1) using the minimisation method was done with six stratification factors (age, axillary lymph node metastasis at surgery or sentinel lymph node biopsy, preoperative or postoperative (neoadjuvant or adjuvant) chemotherapy, preoperative endocrine therapy, proportion of ER-positive cells, and study site). The primary endpoint was invasive disease-free survival, in the full analysis set (all randomly assigned patients, excluding those with significant protocol deviations). The safety analysis set consisted of all patients who received at least one dose of study treatment. Here, we report the results from the interim analysis at the data cutoff date Jan 31, 2019. This trial is registered with Japan Registry of Clinical Trials, jRCTs051180057, and the University hospital Medical Information Network, UMIN000003969. Findings: Between Feb 1, 2012, and Feb 1, 2016, 1930 patients were enrolled in the full analysis set, 957 (50%) received endocrine therapy plus S-1 and 973 (50%) received endocrine therapy alone. Median follow-up was 52·2 months (IQR 42·1–58·9). 155 (16%) patients in the endocrine therapy alone group and in 101 (11%) patients in the endocrine therapy plus S-1 group had invasive disease-free survival events (hazard ratio 0·63, 95% CI 0·49–0·81, p=0·0003). As the primary endpoint was met at interim analysis, the trial was terminated early. The most common grade 3 or worse adverse events were decreased neutrophil count (72 [8%] of 954 patients in the endocrine therapy plus S-1 group vs seven [1%] of 970 patients in the endocrine therapy alone group), diarrhoea (18 [2%] vs none), decreased white blood cells (15 [2%] vs two [<1%]), and fatigue (six [<1%] vs none). Serious adverse events were reported in nine (1%) of 970 patients in the endocrine therapy alone group and 25 (3%) of 954 patients in the endocrine therapy plus S-1 group. There was one (<1%) possible treatment-related death in the endocrine therapy plus S-1 group due to suspected pulmonary artery thrombosis. Interpretation: These data suggest that this combination of S-1 with endocrine therapy could be a potential treatment option for this intermediate and high-risk group of patients with ER-positive, HER2-negative primary breast cancer. Funding: Public Health Research Foundation (Japan), Taiho Pharmaceutical.

    DOI: 10.1016/S1470-2045(20)30534-9

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  84. Management of Abemaciclib-Associated Adverse Events in Patients with Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Safety Analysis of MONARCH 2 and MONARCH 3. 査読有り 国際共著

    Rugo HS, Huober J, García-Sáenz JA, Masuda N, Sohn JH, Andre VAM, Barriga S, Cox J, Goetz M

    The oncologist   26 巻 ( 1 ) 頁: e53 - e65   2021年1月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1002/onco.13531

    PubMed

  85. The efficacy and safety of pertuzumab plus trastuzumab and docetaxel as a first-line therapy in Japanese patients with inoperable or recurrent HER2-positive breast cancer: the COMACHI study. 査読有り

    Takahashi M, Ohtani S, Nagai SE, Takashima S, Yamaguchi M, Tsuneizumi M, Komoike Y, Osako T, Ito Y, Ikeda M, Ishida K, Nakayama T, Takashima T, Asakawa T, Matsumoto S, Shimizu D, Masuda N

    Breast cancer research and treatment   185 巻 ( 1 ) 頁: 125 - 134   2021年1月

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    担当区分:最終著者, 責任著者   記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1007/s10549-020-05921-x

    PubMed

  86. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for previously untreated locally recurrent inoperable or metastatic triple-negative breast cancer (KEYNOTE-355): a randomised, placebo-controlled, double-blind, phase 3 clinical trial. 査読有り 国際共著

    Cortes J, Cescon DW, Rugo HS, Nowecki Z, Im SA, Yusof MM, Gallardo C, Lipatov O, Barrios CH, Holgado E, Iwata H, Masuda N, Otero MT, Gokmen E, Loi S, Guo Z, Zhao J, Aktan G, Karantza V, Schmid P, KEYNOTE, Investigators

    Lancet (London, England)   396 巻 ( 10265 ) 頁: 1817 - 1828   2020年12月

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    記述言語:英語   掲載種別:研究論文(学術雑誌)  

    DOI: 10.1016/S0140-6736(20)32531-9

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  87. Overnight fasting before lapatinib administration to breast cancer patients leads to reduced toxicity compared with nighttime dosing: a retrospective cohort study from a randomized clinical trial.

    Tsuda M, Ishiguro H, Toriguchi N, Masuda N, Bando H, Ohgami M, Homma M, Morita S, Yamamoto N, Kuroi K, Yanagita Y, Takano T, Shimizu S, Toi M

    Cancer medicine   9 巻 ( 24 ) 頁: 9246 - 9255   2020年12月

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    記述言語:英語  

    DOI: 10.1002/cam4.3528

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  88. [Ⅰ.Capecitabine for Adjuvant Therapy in Breast Cancer]. 招待有り 査読有り

    Masuda N

    Gan to kagaku ryoho. Cancer & chemotherapy   47 巻 ( 12 ) 頁: 1673 - 1677   2020年12月

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    担当区分:筆頭著者   記述言語:日本語   掲載種別:研究論文(学術雑誌)  

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  89. [Ⅰ.Capecitabine for Adjuvant Therapy in Breast Cancer]. 招待有り 査読有り

    Masuda N

    Gan to kagaku ryoho. Cancer & chemotherapy   47 巻 ( 12 ) 頁: 1673 - 1677   2020年12月

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    担当区分:筆頭著者   記述言語:日本語   掲載種別:研究論文(学術雑誌)  

    PubMed

  90. Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With ≥ 2 HER2-Directed Regimens: Phase III NALA Trial.

    Saura C, Oliveira M, Feng YH, Dai MS, Chen SW, Hurvitz SA, Kim SB, Moy B, Delaloge S, Gradishar W, Masuda N, Palacova M, Trudeau ME, Mattson J, Yap YS, Hou MF, De Laurentiis M, Yeh YM, Chang HT, Yau T, Wildiers H, Haley B, Fagnani D, Lu YS, Crown J, Lin J, Takahashi M, Takano T, Yamaguchi M, Fujii T, Yao B, Bebchuk J, Keyvanjah K, Bryce R, Brufsky A, NALA Investigators

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology   38 巻 ( 27 ) 頁: 3138 - 3149   2020年9月

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    記述言語:英語  

    DOI: 10.1200/JCO.20.00147

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  91. Ribociclib, a CDK 4/6 inhibitor, plus endocrine therapy in Asian women with advanced breast cancer

    Yap Y.S, Chiu J, Ito Y, Ishikawa T, Aruga T, Kim S.J, Toyama T, Saeki T, Saito M, Gounaris I, Su F, Ji Y, Han Y, Gazdoiu M, Masuda N

    Cancer Science   111 巻 ( 9 ) 頁: 3313 - 3326   2020年9月

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    記述言語:日本語   出版者・発行元:Cancer Science  

    The ongoing, Phase Ib MONALEESASIA study is evaluating the efficacy and safety of ribociclib plus endocrine therapy in Asian patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Eligible patients from Japan, Hong Kong, and Singapore were enrolled in this 2-phase study consisting of a dose-escalation phase to determine the maximum-tolerated dose and the recommended Phase II dose of ribociclib plus letrozole, and a dose-expansion phase to evaluate safety and tolerability of ribociclib plus letrozole, fulvestrant, or tamoxifen. An exploratory biomarker analysis evaluating expression of target genes was also conducted. In the dose-escalation phase, the maximum-tolerated/recommended Phase II doses of ribociclib were lower in Japanese patients (300 mg) than in Asian non-Japanese patients (600 mg). Ribociclib plus endocrine therapy at the recommended Phase II dose had a manageable safety profile, with neutropenia and elevated liver transaminases being the most common adverse events leading to dose modifications or discontinuations, and it demonstrated evidence of clinical activity in both Japanese and Asian non-Japanese patients. Preliminary efficacy in Asian populations is similar to that observed in White populations studied in previous ribociclib (MONALEESA) trials. Biomarker analysis demonstrated suppression of pharmacodynamic biomarker gene expression, indicating inhibition of target genes by ribociclib combined with endocrine therapy. Results from the ongoing study support the use of ribociclib in combination with letrozole in Asian non-Japanese patients at the same dose (600 mg) as White patients. In Japanese patients, a lower dose of ribociclib (300 mg) should be considered. Clinicaltrials.gov: NCT02333370.

    DOI: 10.1111/cas.14554

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  92. Palbociclib-letrozole as first-line treatment for advanced breast cancer: Updated results from a Japanese phase 2 study.

    Takahashi M, Masuda N, Nishimura R, Inoue K, Ohno S, Iwata H, Hashigaki S, Muramatsu Y, Umeyama Y, Toi M

    Cancer medicine   9 巻 ( 14 ) 頁: 4929 - 4940   2020年7月

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    記述言語:英語  

    DOI: 10.1002/cam4.3091

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  93. Outcomes of trastuzumab therapy in HER2-positive early breast cancer patients: extended follow-up of JBCRG-cohort study 01.

    Yamashiro H, Iwata H, Masuda N, Yamamoto N, Nishimura R, Ohtani S, Sato N, Takahashi M, Kamio T, Yamazaki K, Saito T, Kato M, Lee T, Kuroi K, Takano T, Yasuno S, Morita S, Ohno S, Toi M, JBCRG, Collaborative Group

    Breast cancer (Tokyo, Japan)   27 巻 ( 4 ) 頁: 631 - 641   2020年7月

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  94. Correction to: Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD).

    Yamashita T, Masuda N, Saji S, Araki K, Ito Y, Takano T, Takahashi M, Tsurutani J, Koizumi K, Kitada M, Kojima Y, Sagara Y, Tada H, Iwasa T, Kadoya T, Iwatani T, Hasegawa H, Morita S, Ohno S

    Trials   21 巻 ( 1 ) 頁: 503   2020年6月

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  95. Olaparib monotherapy for Asian patients with a germline BRCA mutation and HER2-negative metastatic breast cancer: OlympiAD randomized trial subgroup analysis.

    Im SA, Xu B, Li W, Robson M, Ouyang Q, Yeh DC, Iwata H, Park YH, Sohn JH, Tseng LM, Goessl C, Wu W, Masuda N

    Scientific reports   10 巻 ( 1 ) 頁: 8753   2020年5月

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  96. Trastuzumab, pertuzumab, and eribulin mesylate versus trastuzumab, pertuzumab, and a taxane as a first-line or second-line treatment for HER2-positive, locally advanced or metastatic breast cancer: study protocol for a randomized controlled, non-inferiority, phase III trial in Japan (JBCRG-M06/EMERALD).

    Yamashita T, Masuda N, Saji S, Araki K, Ito Y, Takano T, Takahashi M, Tsurutani J, Koizumi K, Kitada M, Kojima Y, Sagara Y, Tada H, Iwasa T, Kadoya T, Iwatani T, Hasegawa H, Morita S, Ohno S

    Trials   21 巻 ( 1 ) 頁: 391   2020年5月

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  97. Factors associated with prolonged overall survival in patients with postmenopausal estrogen receptor-positive advanced breast cancer using real-world data: a follow-up analysis of the JBCRG-C06 Safari study.

    Kawaguchi H, Masuda N, Nakayama T, Aogi K, Anan K, Ito Y, Ohtani S, Sato N, Saji S, Takano T, Tokunaga E, Nakamura S, Hasegawa Y, Hattori M, Fujisawa T, Morita S, Yamaguchi M, Yamashita H, Yamashita T, Yamamoto Y, Yotsumoto D, Toi M, Ohno S

    Breast cancer (Tokyo, Japan)   27 巻 ( 3 ) 頁: 389 - 398   2020年5月

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  98. Long-term survival analysis of addition of carboplatin to neoadjuvant chemotherapy in HER2-negative breast cancer

    Iwase Madoka, Ando Masashi, Aogi Kenjiro, Aruga Tomoyuki, Inoue Kenichiro, Shimomura Akihiko, Tokunaga Eriko, Masuda Norikazu, Yamauchi Hideko, Yamashita Toshinari, Iwata Hiroji

    BREAST CANCER RESEARCH AND TREATMENT   180 巻 ( 3 ) 頁: 687 - 694   2020年4月

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    記述言語:日本語   出版者・発行元:Breast Cancer Research and Treatment  

    Purpose: Addition of carboplatin (CBDCA) to neoadjuvant chemotherapy (NAC) in triple-negative breast cancer (TNBC) has improved pathological complete response (pCR) rates in previous studies. We present long-term survival outcomes (disease-free survival [DFS], pre-planned secondary endpoint; overall survival [OS], post hoc exploratory endpoint) of our randomized study of the addition of CBDCA to NAC for HER2-negative breast cancer. Methods: Patients with stage II/III, HER2-negative breast cancer (N = 179) were randomly assigned to receive CP–CEF (four 3-week cycles of CBDCA [area under the curve, 5 mg/mL/min, day 1] and weekly paclitaxel [wPTX, 80 mg/m2, day 1, 8, 15] followed by four 3-week cycles of cyclophosphamide, epirubicin, and 5-fluorouracil [CEF, 500/100/500 mg/m2]) or P–CEF (four cycles of wPTX followed by four cycles of CEF) as NAC. DFS and OS were analyzed at each population of pCR status and assigned treatment arm. Results: Of 179 patients, 154 were available for long-term follow-up. At a median follow-up of 6.6 years (range, 0.7–8.0 years), patients who achieved pCR [n = 42, 23.5% (CP–CEF: n = 28, P–CEF: n = 16)] had longer DFS and OS than non-pCR patients [DFS; HR 0.15 (0.04–0.61), P = 0.008, OS; log-rank P = 0.003]. Addition of carboplatin to NAC significantly improved DFS and OS in the subset of patients with TNBC [DFS: HR, 0.22 (0.06–0.82), P = 0.015; OS: HR, 0.12 (0.01–0.96), P = 0.046], but not in the subset of patients with hormone receptor-positive disease or among all patients. Conclusions: Addition of carboplatin to neoadjuvant chemotherapy significantly improved DFS and OS in patients with TNBC but not in those with hormone receptor-positive, HER2-negative breast cancer.

    DOI: 10.1007/s10549-020-05580-y

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  99. A randomized study comparing docetaxel/cyclophosphamide (TC), 5-fluorouracil/epirubicin/cyclophosphamide (FEC) followed by TC, and TC followed by FEC for patients with hormone receptor-positive HER2-negative primary breast cancer.

    Ishiguro H, Masuda N, Sato N, Higaki K, Morimoto T, Yanagita Y, Mizutani M, Ohtani S, Kaneko K, Fujisawa T, Takahashi M, Kadoya T, Matsunami N, Yamamoto Y, Ohno S, Takano T, Morita S, Tanaka-Mizuno S, Toi M

    Breast cancer research and treatment   180 巻 ( 3 ) 頁: 715 - 724   2020年4月

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  100. Breast metastasis from rectal cancer with BRAF V600E mutation: a case report with a review of the literature.

    Hasegawa H, Nagata Y, Sakakibara Y, Miyake M, Mori K, Masuda N, Mano M, Nakazuru S, Ishida H, Mita E

    Clinical journal of gastroenterology   13 巻 ( 2 ) 頁: 153 - 157   2020年4月

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  101. Hematologic adverse events following palbociclib dose reduction in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: pooled analysis from randomized phase 2 and 3 studies.

    Ettl J, Im SA, Ro J, Masuda N, Colleoni M, Schnell P, Bananis E, Lu DR, Cristofanilli M, Rugo HS, Finn RS

    Breast cancer research : BCR   22 巻 ( 1 ) 頁: 27   2020年3月

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  102. A randomized, 3-arm, neoadjuvant, phase 2 study comparing docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP), TCbHP followed by trastuzumab emtansine and pertuzumab (T-DM1+P), and T-DM1+P in HER2-positive primary breast cancer.

    Masuda N, Ohtani S, Takano T, Inoue K, Suzuki E, Nakamura R, Bando H, Ito Y, Ishida K, Yamanaka T, Kuroi K, Yasojima H, Kasai H, Takasuka T, Sakurai T, Kataoka TR, Morita S, Ohno S, Toi M

    Breast cancer research and treatment   180 巻 ( 1 ) 頁: 135 - 146   2020年2月

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  103. Multicenter study of primary systemic therapy with docetaxel, cyclophosphamide and trastuzumab for HER2-positive operable breast cancer: the JBCRG-10 study.

    Ueno T, Masuda N, Sato N, Ohtani S, Yamamura J, Matsunami N, Kashiwaba M, Takano T, Takahashi M, Kaneko K, Ohno S, Morita S, Toi M

    Japanese journal of clinical oncology   50 巻 ( 1 ) 頁: 3 - 11   2020年1月

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    記述言語:英語  

    DOI: 10.1093/jjco/hyz119

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  104. The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial.

    Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Barriga S, Hurt K, Frenzel M, Johnston S, Llombart-Cussac A

    JAMA oncology   6 巻 ( 1 ) 頁: 116 - 124   2020年1月

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  105. Taxane-based combinations as adjuvant chemotherapy for node-positive ER-positive breast cancer based on 2004-2009 data from the Breast Cancer Registry of the Japanese Breast Cancer Society.

    Hojo T, Masuda N, Iwamoto T, Niikura N, Anan K, Aogi K, Ohnishi T, Yamauchi C, Yoshida M, Kinoshita T, Masuoka H, Sagara Y, Sakatani T, Kojima Y, Tsuda H, Kumamaru H, Miyata H, Nakamura S

    Breast cancer (Tokyo, Japan)   27 巻 ( 1 ) 頁: 85 - 91   2020年1月

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  106. Clinical significance of evaluating hormone receptor and HER2 protein using cell block against metastatic breast cancer: a multi-institutional study.

    Matsui A, Murata Y, Masuda N, Mori K, Takahashi M, Yamashiro K, Aogi K, Maeda S, Itou M, Ozaki S, Kuraoka K, Satou Y, Ichihara S, Tokunaga E, Taguchi K, Watanabe T, Suzuki H, Nagayama A, Nishimura R

    Oncotarget   10 巻 ( 55 ) 頁: 5680 - 5689   2019年10月

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  107. Patient-reported outcomes in patients with a germline BRCA mutation and HER2-negative metastatic breast cancer receiving olaparib versus chemotherapy in the OlympiAD trial.

    Robson M, Ruddy KJ, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Li W, Tung N, Armstrong A, Delaloge S, Bannister W, Goessl C, Degboe A, Hettle R, Conte P

    European journal of cancer (Oxford, England : 1990)   120 巻   頁: 20 - 30   2019年10月

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  108. Gene Alterations in Triple-Negative Breast Cancer Patients in a Phase I/II Study of Eribulin and Olaparib Combination Therapy.

    Shimomura A, Yonemori K, Yoshida M, Yoshida T, Yasojima H, Masuda N, Aogi K, Takahashi M, Naito Y, Shimizu S, Nakamura R, Hamada A, Michimae H, Hashimoto J, Yamamoto H, Kawachi A, Shimizu C, Fujiwara Y, Tamura K

    Translational oncology   12 巻 ( 10 ) 頁: 1386 - 1394   2019年10月

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  109. Distinct gene expression profiles between primary breast cancers and brain metastases from pair-matched samples.

    Iwamoto T, Niikura N, Ogiya R, Yasojima H, Watanabe KI, Kanbayashi C, Tsuneizumi M, Matsui A, Fujisawa T, Iwasa T, Shien T, Saji S, Masuda N, Iwata H

    Scientific reports   9 巻 ( 1 ) 頁: 13343   2019年9月

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  110. Neutropenia management with palbociclib in Japanese patients with advanced breast cancer.

    Masuda N, Mukai H, Inoue K, Rai Y, Ohno S, Mori Y, Hashigaki S, Muramatsu Y, Umeyama Y, Iwata H, Toi M

    Breast cancer (Tokyo, Japan)   26 巻 ( 5 ) 頁: 637 - 650   2019年9月

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  111. Neoadjuvant exemestane or exemestane plus docetaxel and cyclophosphamide tailored by clinicopathological response to 12 weeks' exemestane exposure in patients with estrogen receptor-positive breast cancer: A multicenter, open-label, phase II study.

    Sato N, Masuda N, Morimoto T, Ueno T, Kanbayashi C, Kaneko K, Yasojima H, Saji S, Sasano H, Morita S, Ohno S, Toi M

    Cancer medicine   8 巻 ( 12 ) 頁: 5468 - 5481   2019年9月

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    記述言語:英語  

    DOI: 10.1002/cam4.2423

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  112. Correction to: Neutropenia management with palbociclib in Japanese patients with advanced breast cancer.

    Masuda N, Mukai H, Inoue K, Rai Y, Ohno S, Mori Y, Hashigaki S, Muramatsu Y, Umeyama Y, Iwata H, Toi M

    Breast cancer (Tokyo, Japan)   26 巻 ( 5 ) 頁: 651   2019年9月

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  113. Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer.

    Iwata H, Masuda N, Kim SB, Inoue K, Rai Y, Fujita T, Chiu J, Ohtani S, Takahashi M, Miyaki T, Lu YS, Xu B, Yap YS, Bustam A, Yao B, Zhang B, Bryce R, Chan A

    Future oncology (London, England)   15 巻 ( 21 ) 頁: 2489 - 2501   2019年7月

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    記述言語:英語  

    DOI: 10.2217/fon-2019-0143

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  114. Palbociclib Plus Letrozole as First-Line Therapy in Postmenopausal Asian Women With Metastatic Breast Cancer: Results From the Phase III, Randomized PALOMA-2 Study.

    Im SA, Mukai H, Park IH, Masuda N, Shimizu C, Kim SB, Im YH, Ohtani S, Huang Bartlett C, Lu DR, Iyer S, Mori Y, Mori A, Gauthier E, Finn RS, Toi M

    Journal of global oncology   5 巻   頁: 1 - 19   2019年5月

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    記述言語:英語  

    DOI: 10.1200/JGO.18.00173

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  115. Palbociclib in combination with letrozole in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-2 subgroup analysis of Japanese patients.

    Mukai H, Shimizu C, Masuda N, Ohtani S, Ohno S, Takahashi M, Yamamoto Y, Nishimura R, Sato N, Ohsumi S, Iwata H, Mori Y, Hashigaki S, Muramatsu Y, Nagasawa T, Umeyama Y, Lu DR, Toi M

    International journal of clinical oncology   24 巻 ( 3 ) 頁: 274 - 287   2019年3月

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  116. A phase I/II trial of olaparib tablet in combination with eribulin in Japanese patients with advanced or metastatic triple-negative breast cancer previously treated with anthracyclines and taxanes.

    Yonemori K, Shimomura A, Yasojima H, Masuda N, Aogi K, Takahashi M, Naito Y, Shimizu S, Nakamura R, Hashimoto J, Yamamoto H, Hirakawa A, Michimae H, Hamada A, Yoshida T, Sukigara T, Tamura K, Fujiwara Y

    European journal of cancer (Oxford, England : 1990)   109 巻   頁: 84 - 91   2019年3月

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  117. Palbociclib in combination with fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: PALOMA-3 subgroup analysis of Japanese patients.

    Masuda N, Inoue K, Nakamura R, Rai Y, Mukai H, Ohno S, Hara F, Mori Y, Hashigaki S, Muramatsu Y, Nagasawa T, Umeyama Y, Huang X, Iwata H

    International journal of clinical oncology   24 巻 ( 3 ) 頁: 262 - 273   2019年3月

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  118. Differential Involvement of Autophagy and Apoptosis in Response to Chemoendocrine and Endocrine Therapy in Breast Cancer: JBCRG-07TR.

    Ueno T, Masuda N, Kamigaki S, Morimoto T, Saji S, Imoto S, Sasano H, Toi M

    International journal of molecular sciences   20 巻 ( 4 )   2019年2月

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    記述言語:英語  

    DOI: 10.3390/ijms20040984

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  119. Associations in tumor infiltrating lymphocytes between clinicopathological factors and clinical outcomes in estrogen receptor-positive/human epidermal growth factor receptor type 2 negative breast cancer

    Miyoshi Y, Shien T, Ogiya A, Ishida N, Yamazaki K, Horii R.I.E, Horimoto Y, Masuda N, Yasojima H, Inao T, Osako T, Takahashi M, Tomioka N, Wanifuchi-Endo Y, Hosoda M, Doihara H, Yamashita H

    Oncology Letters   17 巻 ( 2 ) 頁: 2177 - 2186   2019年2月

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    記述言語:日本語   出版者・発行元:Oncology Letters  

    The value of assessing tumor infiltrating lymphocytes (TILs) in estrogen receptor (ER) positive/human epidermal growth factor receptor type 2 (HER2) negative breast cancer has yet to be determined. In the present study, a total of 184 cases with early distant recurrence detected within 5 years following the primary operation, 134 with late distant recurrence diagnosed following 5 years or longer and 321 controls without recurrence for >10 years following starting the initial treatment for ER-positive/HER2 negative breast cancer, registered in 9 institutions, were analyzed. The distributions of TILs and their clinical relevance were investigated. TIL distributions did not differ significantly among the early, late and no recurrence groups, employing a 30% cut-off point as a dichotomous variable. In those who had received adjuvant chemotherapy as well as endocrine therapy, a trend toward higher TIL proportions was detected when the early recurrence group was compared with the no recurrence group employing the 30% cut-off point (P=0.064). The TIL distributions were significantly associated with nodal metastasis (P=0.004), ER status (P=0.045), progesterone receptor (PgR) status (P=0.002), tumor grade (P=0.021), and the Ki67 labeling index (LI) (P=0.002) in the no recurrence group and with the Ki67 LI in the recurrence groups (P=0.002 in early recurrence group, P=0.023 in late recurrence group). High TIL distributions also predicted shorter survival time following the detection of recurrence (P=0.026). However, these prognostic interactions were not significant in multivariate analysis (P=0.200). The present retrospective study demonstrated no significant interaction between TIL proportions and the timing of recurrence. However, higher TIL proportions were observed in breast cancer patients with aggressive biological phenotypes, which tended to be more responsive to chemotherapy. The clinical relevance of stromal TILs for identifying patients who would likely benefit from additional therapies merits further investigation in a larger patient population.

    DOI: 10.3892/ol.2018.9853

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  120. Validation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study

    Iwata H, Masuda N, Yamamoto Y, Fujisawa T, Toyama T, Kashiwaba M, Ohtani S, Taira N, Sakai T, Hasegawa Y, Nakamura R, Akabane H, Shibahara Y, Sasano H, Yamaguchi T, Sakamaki K, Bailey H, Cherbavaz D.B, Jakubowski D.M, Sugiyama N, Chao C, Ohashi Y

    Breast Cancer Research and Treatment   173 巻 ( 1 ) 頁: 123 - 133   2019年1月

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    記述言語:日本語   出版者・発行元:Breast Cancer Research and Treatment  

    Purpose: The Recurrence Score test is validated to predict benefit of adjuvant chemotherapy. TransNEOS, a translational study of New Primary Endocrine-therapy Origination Study (NEOS), evaluated whether Recurrence Score results can predict clinical response to neoadjuvant letrozole. Methods: NEOS is a phase 3 clinical trial of hormonal therapy ± adjuvant chemotherapy for postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer, after six months of neoadjuvant letrozole and breast surgery. TransNEOS patients had tumors ≥ 2 cm and archived core-biopsy samples taken before neoadjuvant letrozole and subsequently sent for Recurrence Score testing. The primary endpoint was to evaluate clinical (complete or partial) response to neoadjuvant letrozole for RS < 18 versus RS ≥ 31. Secondary endpoints included evaluation of clinical response and rate of breast-conserving surgery (BCS) by continuous Recurrence Score result, ESR1 and PGR single-gene scores, and ER gene-group score. Results: Of 295 TransNEOS patients (median age 63 years; median tumor size 25 mm; 66% grade 1), 53.2% had RS < 18, 28.5% had RS18–30, and 18.3% had RS ≥ 31. Clinical response rates were 54% (RS < 18), 42% (RS18–30), and 22% (RS ≥ 31). A higher proportion of patients with RS < 18 had clinical responses (p < 0.001 vs. RS ≥ 31). In multivariable analyses, continuous Recurrence Score result (p < 0.001), ESR1 score (p = 0.049), PGR score (p < 0.001), and ER gene-group score (p < 0.001) were associated with clinical response. Recurrence Score group was significantly associated with rate of BCS after neoadjuvant treatment (RS < 18 vs. RS ≥ 31, p = 0.010). Conclusion: The Recurrence Score test is validated to predict clinical response to neoadjuvant letrozole in postmenopausal patients with ER+, HER2-negative, clinically node-negative breast cancer.

    DOI: 10.1007/s10549-018-4964-y

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  121. Changes in Recurrence Score by neoadjuvant endocrine therapy of breast cancer and their prognostic implication.

    Ueno T, Saji S, Masuda N, Iwata H, Kuroi K, Sato N, Takei H, Yamamoto Y, Ohno S, Yamashita H, Hisamatsu K, Aogi K, Sasano H, Toi M

    ESMO open   4 巻 ( 1 ) 頁: e000476   2019年

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  122. Prediction of postoperative disease-free survival and brain metastasis for HER2-positive breast cancer patients treated with neoadjuvant chemotherapy plus trastuzumab using a machine learning algorithm.

    Takada M, Sugimoto M, Masuda N, Iwata H, Kuroi K, Yamashiro H, Ohno S, Ishiguro H, Inamoto T, Toi M

    Breast cancer research and treatment   172 巻 ( 3 ) 頁: 611 - 618   2018年12月

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  123. Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer.

    Turner NC, Slamon DJ, Ro J, Bondarenko I, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Loibl S, André F, Puyana Theall K, Huang X, Giorgetti C, Huang Bartlett C, Cristofanilli M

    The New England journal of medicine   379 巻 ( 20 ) 頁: 1926 - 1936   2018年11月

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    記述言語:英語  

    DOI: 10.1056/NEJMoa1810527

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  124. Predictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in PALOMA-3.

    Cristofanilli M, DeMichele A, Giorgetti C, Turner NC, Slamon DJ, Im SA, Masuda N, Verma S, Loi S, Colleoni M, Theall KP, Huang X, Liu Y, Bartlett CH

    European journal of cancer (Oxford, England : 1990)   104 巻   頁: 21 - 31   2018年11月

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  125. Buparlisib plus fulvestrant versus placebo plus fulvestrant for postmenopausal, hormone receptor-positive, human epidermal growth factor receptor 2-negative, advanced breast cancer: Overall survival results from BELLE-2.

    Campone M, Im SA, Iwata H, Clemons M, Ito Y, Awada A, Chia S, Jagiełło-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Cortés J, De Laurentiis M, Arteaga CL, Jiang Z, Jonat W, Le Mouhaër S, Sankaran B, Bourdeau L, El-Hashimy M, Sellami D, Baselga J

    European journal of cancer (Oxford, England : 1990)   103 巻   頁: 147 - 154   2018年11月

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  126. A randomized, open-label, phase III trial of pertuzumab retreatment in HER2-positive locally advanced/metastatic Breast cancer patients previously treated with pertuzumab, trastuzumab and chemotherapy: The Japan Breast cancer research group-M05 PRECIOUS study

    Yamamoto Y, Iwata H, Ueno T, Taira N, Kashiwaba M, Takahashi M, Tada H, Tsugawa K, Toyama T, Niikura N, Hara F, Fujisawa T, Yoshinami T, Saji S, Takano T, Masuda N, Morita S, Toi M, Ohno S

    Japanese Journal of Clinical Oncology   48 巻 ( 9 ) 頁: 855 - 859   2018年9月

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    記述言語:日本語   出版者・発行元:Japanese Journal of Clinical Oncology  

    The PRECIOUS study (UMIN000018202) is being conducted as a multicenter, randomized, open-label Phase III study to determine if retreatment with pertuzumab is more effective than conventional treatment in HER2-positive locally advanced (LA)/metastatic Breast cancer (MBC) patients previously treated with pertuzumab, trastuzumab and chemotherapy. Patients are randomized 1:1 into chemotherapy plus trastuzumab with or without pertuzumab groups. The latest regimen before enrollment did not include pertuzumab, and the number of previous chemotherapy regimens for LA/MBC did not exceed three. The primary endpoint is investigator-assessed progression-free survival. Secondary endpoints include independent reviewer-assessed progression-free survival, progression-free survival in patients treated with trastuzumab emtansine as the latest regimen, response rate, response duration, overall survival, safety and health-related quality of life. Target accrual is 370 patients, allowing the observation of 325 events, yielding an 80% power for detection of a hazard ratio of 0.739 with a one-sided 5% level of significance.

    DOI: 10.1093/jjco/hyy097

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  127. Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: a pooled analysis of randomised PALOMA clinical studies.

    Rugo HS, Turner NC, Finn RS, Joy AA, Verma S, Harbeck N, Masuda N, Im SA, Huang X, Kim S, Sun W, Iyer S, Schnell P, Bartlett CH, Johnston S

    European journal of cancer (Oxford, England : 1990)   101 巻   頁: 123 - 133   2018年9月

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  128. Bi-weekly eribulin therapy for metastatic breast cancer: a multicenter phase II prospective study (JUST-STUDY).

    Ohtani S, Nakayama T, Yoshinami T, Watanabe KI, Hara F, Sagara Y, Kawaguchi H, Higaki K, Matsunami N, Hasegawa Y, Takahashi M, Mizutani M, Morimoto T, Sato M, Itoh M, Morita S, Masuda N

    Breast cancer (Tokyo, Japan)   25 巻 ( 4 ) 頁: 438 - 446   2018年7月

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  129. Neoadjuvant endocrine therapy with exemestane followed by response-guided combination therapy with low-dose cyclophosphamide in postmenopausal patients with estrogen receptor-positive breast cancer: A multicenter, open-label, phase II study.

    Sato N, Masuda N, Morimoto T, Ueno T, Kanbayashi C, Kaneko K, Yasojima H, Saji S, Sasano H, Morita S, Ohno S, Toi M

    Cancer medicine     2018年6月

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    記述言語:英語  

    DOI: 10.1002/cam4.1600

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  130. Case report of a dose-volume histogram analysis of rib fracture after accelerated partial breast irradiation: interim analysis of a Japanese prospective multi-institutional feasibility study.

    Yoshida K, Otani Y, Nose T, Yoden E, Asahi S, Tsukiyama I, Dokiya T, Saeki T, Fukuda I, Sekine H, Kumazaki Y, Takahashi T, Kotsuma T, Masuda N, Nakashima K, Matsumura T, Nakagawa S, Tachiiri S, Moriguchi Y, Itami J, Oguchi M

    Journal of contemporary brachytherapy   10 巻 ( 3 ) 頁: 274 - 278   2018年6月

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    記述言語:英語  

    DOI: 10.5114/jcb.2018.76983

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  131. A multicenter phase II trial of neoadjuvant letrozole plus low-dose cyclophosphamide in postmenopausal patients with estrogen receptor-positive breast cancer (JBCRG-07): therapeutic efficacy and clinical implications of circulating endothelial cells.

    Ueno T, Masuda N, Kamigaki S, Morimoto T, Akiyama F, Kurosumi M, Tsuda H, Mikami Y, Tanaka S, Morita S, Toi M

    Cancer medicine   7 巻 ( 6 ) 頁: 2442 - 2451   2018年6月

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    記述言語:英語  

    DOI: 10.1002/cam4.1516

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  132. Randomized phase II study of anastrozole plus tegafur-uracil as neoadjuvant therapy for ER-positive breast cancer in postmenopausal Japanese women (Neo-ACET BC).

    Nakayama T, Sagara Y, Takashima T, Matsunami N, Masuda N, Miyoshi Y, Taguchi T, Aono T, Ito T, Kagimura T, Noguchi S

    Cancer chemotherapy and pharmacology   81 巻 ( 4 ) 頁: 755 - 762   2018年4月

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  133. Combined effects of neoadjuvant letrozole and zoledronic acid on γδT cells in postmenopausal women with early-stage breast cancer.

    Sugie T, Suzuki E, Yamauchi A, Yamagami K, Masuda N, Gondo N, Sumi E, Ikeda T, Tada H, Uozumi R, Kanao S, Tanaka Y, Hamazaki Y, Minato N, Toi M

    Breast (Edinburgh, Scotland)   38 巻   頁: 114 - 119   2018年4月

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  134. Palbociclib in combination with letrozole as first-line treatment for advanced breast cancer: A Japanese phase II study.

    Masuda N, Nishimura R, Takahashi M, Inoue K, Ohno S, Iwata H, Mori Y, Hashigaki S, Muramatsu Y, Nagasawa T, Umeyama Y, Toi M

    Cancer science   109 巻 ( 3 ) 頁: 803 - 813   2018年3月

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    記述言語:英語  

    DOI: 10.1111/cas.13507

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  135. Phase I dose-finding study of eribulin and capecitabine for metastatic breast cancer: JBCRG-18 cape study.

    Hattori M, Ishiguro H, Masuda N, Yoshimura A, Ohtani S, Yasojima H, Morita S, Ohno S, Iwata H

    Breast cancer (Tokyo, Japan)   25 巻 ( 1 ) 頁: 108 - 117   2018年1月

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  136. Durable complete response in HER2-positive breast cancer: a multicenter retrospective analysis.

    Niikura N, Shimomura A, Fukatsu Y, Sawaki M, Ogiya R, Yasojima H, Fujisawa T, Yamamoto M, Tsuneizumi M, Kitani A, Watanabe J, Matsui A, Takahashi Y, Takashima S, Shien T, Tamura K, Saji S, Masuda N, Tokuda Y, Iwata H

    Breast cancer research and treatment   167 巻 ( 1 ) 頁: 81 - 87   2018年1月

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  137. Correction to: Phase I dose-finding study of eribulin and capecitabine for metastatic breast cancer: JBCRG-18 cape study.

    Hattori M, Ishiguro H, Masuda N, Yoshimura A, Ohtani S, Yasojima H, Morita S, Ohno S, Iwata H

    Breast cancer (Tokyo, Japan)   25 巻 ( 1 ) 頁: 126   2018年1月

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  138. Factors associated with prolonged time to treatment failure with fulvestrant 500 mg in patients with post-menopausal estrogen receptor-positive advanced breast cancer: a sub-group analysis of the JBCRG-C06 Safari study.

    Kawaguchi H, Masuda N, Nakayama T, Aogi K, Anan K, Ito Y, Ohtani S, Sato N, Saji S, Takano T, Tokunaga E, Nakamura S, Hasegawa Y, Hattori M, Fujisawa T, Morita S, Yamaguchi M, Yamashita H, Yamashita T, Yamamoto Y, Yotsumoto D, Toi M, Ohno S

    Current medical research and opinion   34 巻 ( 1 ) 頁: 49 - 54   2018年1月

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  139. Survival Outcomes of Retreatment with Trastuzumab and Cytotoxic Chemotherapy for HER2-Positive Recurrent Patients With Breast Cancer Who Had Been Treated with Neo/adjuvant Trastuzumab Plus Multidrug Chemotherapy: A Japanese Multicenter Observational Study.

    Yamashiro H, Sawaki M, Masuda N, Okumura Y, Takano T, Tokunaga E, Saito T, Sagara Y, Yamazaki K, Kawaguchi Y, Lee T, Ozaki S, Yamagami K, Yamamoto N, Kuroi K, Suwa H, Ohtani S, Ito T, Yasuno S, Morita S, Ohno S, Toi M

    Breast cancer : basic and clinical research   12 巻   頁: 1178223418786243   2018年

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  140. Impact of clinical response to neoadjuvant endocrine therapy on patient outcomes: a follow-up study of JFMC34-0601 multicentre prospective neoadjuvant endocrine trial.

    Ueno T, Saji S, Masuda N, Kuroi K, Sato N, Takei H, Yamamoto Y, Ohno S, Yamashita H, Hisamatsu K, Aogi K, Iwata H, Yamanaka T, Sasano H, Toi M

    ESMO open   3 巻 ( 2 ) 頁: e000314   2018年

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  141. Nab-paclitaxel plus carboplatin as an effective and safe chemotherapy regimen for pulmonary carcinosarcoma with interstitial lung disease: A case report

    Niwa H, Otani S, Nakada N, Sasaki J, Saka H, Masuda N

    Respiratory Medicine Case Reports   23 巻   頁: 131 - 135   2018年

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    記述言語:日本語   出版者・発行元:Respiratory Medicine Case Reports  

    Carcinosarcoma is a rare histological type of non-small cell carcinoma (NSCLC), and its prognosis has been reported to be worse compared with other NSCLCs. Nanoparticle albumin-bound paclitaxel (nab-PTX) + carboplatin (CBDCA) achieves a favorable response rate in patients with non-small cell lung cancer (NSCLC). We administered nab-PTX + CBDCA to a 68-year-old man with postoperative recurrent carcinosarcoma with interstitial lung disease (ILD). A partial response was evident after four cycles of chemotherapy. To the best of our knowledge, the present study is the first to report the safety and efficacy of nab-PTX + CBDCA for treating carcinosarcoma with ILD.

    DOI: 10.1016/j.rmcr.2018.01.006

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  142. Capecitabine for primary breast cancer.

    Toi M, Masuda N, Lee SJ

    Oncotarget   8 巻 ( 67 ) 頁: 110739 - 110740   2017年12月

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  143. Comparison of immune microenvironments between primary tumors and brain metastases in patients with breast cancer.

    Ogiya R, Niikura N, Kumaki N, Yasojima H, Iwasa T, Kanbayashi C, Oshitanai R, Tsuneizumi M, Watanabe KI, Matsui A, Fujisawa T, Saji S, Masuda N, Tokuda Y, Iwata H

    Oncotarget   8 巻 ( 61 ) 頁: 103671 - 103681   2017年11月

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  144. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy.

    Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology   35 巻 ( 25 ) 頁: 2875 - 2884   2017年9月

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  145. Palbociclib Combined with Fulvestrant in Premenopausal Women with Advanced Breast Cancer and Prior Progression on Endocrine Therapy: PALOMA-3 Results.

    Loibl S, Turner NC, Ro J, Cristofanilli M, Iwata H, Im SA, Masuda N, Loi S, André F, Harbeck N, Verma S, Folkerd E, Puyana Theall K, Hoffman J, Zhang K, Bartlett CH, Dowsett M

    The oncologist   22 巻 ( 9 ) 頁: 1028 - 1038   2017年9月

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  146. Adjuvant Capecitabine for Breast Cancer.

    Toi M, Masuda N, Ohashi Y

    The New England journal of medicine   377 巻 ( 8 ) 頁: 791 - 2   2017年8月

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    記述言語:英語  

    DOI: 10.1056/NEJMc1708487

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  147. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation.

    Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P

    The New England journal of medicine   377 巻 ( 6 ) 頁: 523 - 533   2017年8月

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    記述言語:英語  

    DOI: 10.1056/NEJMoa1706450

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  148. PALOMA-3: Phase III Trial of Fulvestrant With or Without Palbociclib in Premenopausal and Postmenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer That Progressed on Prior Endocrine Therapy-Safety and Efficacy in Asian Patients.

    Iwata H, Im SA, Masuda N, Im YH, Inoue K, Rai Y, Nakamura R, Kim JH, Hoffman JT, Zhang K, Giorgetti C, Iyer S, Schnell PT, Bartlett CH, Ro J

    Journal of global oncology   3 巻 ( 4 ) 頁: 289 - 303   2017年8月

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  149. Erratum to: Post-relapse survival in patients with the early and late distant recurrence in estrogen receptor-positive HER2-negative breast cancer (Breast Cancer, (2017), 24, 3, (473-482), 10.1007/s12282-016-0730-3)

    Ogiya A, Yamazaki K, Horii R, Shien T, Horimoto Y, Masuda N, Inao T, Hosoda M, Ishida N, Osako T, Takahashi M, Endo Y, Miyoshi Y, Yasojima H, Tomioka N, Yamashita H

    Breast Cancer   24 巻 ( 4 ) 頁: 642   2017年7月

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    記述言語:日本語   出版者・発行元:Breast Cancer  

    Unfortunately, in the original publication of this article, the P value of “ER (%), median (range)” was misplaced to previous row “Tumor grade 3” in Table 4. The original article was corrected.

    DOI: 10.1007/s12282-017-0771-2

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  150. Uncertainty of cosmetic evaluation after accelerated partial breast irradiation: interim analysis of a Japanese prospective multi-institutional feasibility study.

    Yoden E, Nose T, Otani Y, Asahi S, Tsukiyama I, Dokiya T, Saeki T, Fukuda I, Sekine H, Shikama N, Kumazaki Y, Takahashi T, Yoshida K, Kotsuma T, Masuda N, Nakashima K, Matsumura T, Nakagawa S, Tachiiri S, Moriguchi Y, Itami J, Oguchi M

    Japanese journal of radiology   35 巻 ( 7 ) 頁: 381 - 388   2017年7月

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  151. Buparlisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal, hormone receptor-positive, HER2-negative, advanced breast cancer (BELLE-2): a randomised, double-blind, placebo-controlled, phase 3 trial.

    Baselga J, Im SA, Iwata H, Cortés J, De Laurentiis M, Jiang Z, Arteaga CL, Jonat W, Clemons M, Ito Y, Awada A, Chia S, Jagiełło-Gruszfeld A, Pistilli B, Tseng LM, Hurvitz S, Masuda N, Takahashi M, Vuylsteke P, Hachemi S, Dharan B, Di Tomaso E, Urban P, Massacesi C, Campone M

    The Lancet. Oncology   18 巻 ( 7 ) 頁: 904 - 916   2017年7月

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  152. Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy.

    Masuda N, Lee SJ, Ohtani S, Im YH, Lee ES, Yokota I, Kuroi K, Im SA, Park BW, Kim SB, Yanagita Y, Ohno S, Takao S, Aogi K, Iwata H, Jeong J, Kim A, Park KH, Sasano H, Ohashi Y, Toi M

    The New England journal of medicine   376 巻 ( 22 ) 頁: 2147 - 2159   2017年6月

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    記述言語:英語  

    DOI: 10.1056/NEJMoa1612645

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  153. Tumor thickness and histological features as predictors of invasive foci within preoperatively diagnosed ductal carcinoma in situ.

    Mori K, Takeda M, Kodama Y, Kiyokawa H, Yasojima H, Mizutani M, Otani Y, Morikawa N, Masuda N, Mano M

    Human pathology   64 巻   頁: 145 - 155   2017年6月

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  154. Widespread subdural metastasis from breast cancer progressing rapidly with cerebral herniation: A case report.

    Okita Y, Masuda N, Mizutani M, Kodama Y, Mori K, Mano M, Nakagawa T, Nakajima S, Fujinaka T

    Molecular and clinical oncology   6 巻 ( 6 ) 頁: 960 - 962   2017年6月

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    記述言語:英語  

    DOI: 10.3892/mco.2017.1233

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  155. First-line bevacizumab plus paclitaxel in Japanese patients with HER2-negative metastatic breast cancer: subgroup results from the randomized Phase III MERiDiAN trial.

    Masuda N, Takahashi M, Nakagami K, Okumura Y, Nakayama T, Sato N, Kanatani K, Tajima K, Kashiwaba M

    Japanese journal of clinical oncology   47 巻 ( 5 ) 頁: 385 - 392   2017年5月

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    記述言語:英語  

    DOI: 10.1093/jjco/hyx001

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  156. Post-relapse survival in patients with the early and late distant recurrence in estrogen receptor-positive HER2-negative breast cancer

    Ogiya A, Yamazaki K, Horii R, Shien T, Horimoto Y, Masuda N, Inao T, Hosoda M, Ishida N, Osako T, Takahashi M, Endo Y, Miyoshi Y, Yasojima H, Tomioka N, Yamashita H

    Breast Cancer   24 巻 ( 3 ) 頁: 473 - 482   2017年5月

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    記述言語:日本語   出版者・発行元:Breast Cancer  

    Background: Few studies have been performed on post-relapse survival in patients with the early and late distant recurrence in estrogen receptor (ER)-positive, HER2-negative breast cancer. Methods: A total of 205 patients with the early distant recurrence and 134 patients with the late distant recurrence of ER-positive, HER2-negative breast cancer who had undergone breast surgery or neoadjuvant chemotherapy between January 2000 and December 2004 were registered from nine institutions. Prognostic factors for post-relapse survival in patients with the early and late recurrence were analyzed. Results: Post-relapse survival was significantly longer in patients with the late recurrence than in patients with the early recurrence. Predictive factors for post-relapse survival in patients with the early recurrence were lack of adjuvant chemotherapy, a long disease-free interval, and long durations of endocrine therapies and chemotherapies after relapse. In patients with the late recurrence, post-relapse survival was significantly improved for those individuals with one metastatic organ at relapse and individuals who were treated with the first-line and subsequent endocrine therapies for prolonged periods. Moreover, ER expression in primary breast tumors of late recurrence patients was significantly higher with a duration of the first-line endocrine therapy >6 months than in those with a duration ≤6 months. Conclusion: Predictors for prognosis after relapse differed between patients with the early and late distant recurrence. Endocrine responsiveness after relapse is a key factor for improved post-relapse survival, and it is thus important to establish whether metastatic tumors are endocrine-resistant in ER-positive, HER2-negative recurrent breast cancer.

    DOI: 10.1007/s12282-016-0730-3

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  157. Randomized phase II study of nab-paclitaxel as first-line chemotherapy in patients with HER2-negative metastatic breast cancer

    Tamura K, Inoue K, Masuda N, Takao S, Kashiwaba M, Tokuda Y, Iwata H, Yamamoto N, Aogi K, Saeki T, Nakayama T, Sato N, Toyama T, Ishida T, Arioka H, Saito M, Ohno S, Yamauchi H, Yamada K, Watanabe J, Ishiguro H, Fujiwara Y

    Cancer Science   108 巻 ( 5 ) 頁: 987 - 994   2017年5月

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    記述言語:日本語   出版者・発行元:Cancer Science  

    Weekly administration of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) has been shown to be a safe and effective treatment for metastatic breast cancer (MBC) in clinical studies. We conducted a multicenter, randomized, open-label phase II study to compare the efficacy and safety of weekly nab-paclitaxel and docetaxel in Japanese patients with human epidermal growth factor receptor 2-negative MBC. The primary endpoint was progression-free survival (PFS). Patients were randomized to receive nab-paclitaxel (150 mg/m2 nab-paclitaxel once per week for 3 of 4 weeks; n = 100) or docetaxel (75 mg/m2 docetaxel every 3 weeks; n = 100). The median PFS by independent radiologist assessment was 9.8 months (90% confidence interval [CI]: 8.5–11.2) for nab-paclitaxel and 11.2 months (90% CI: 8.4–13.8) for docetaxel (hazard ratio: 1.25, P = 0.363), and the median overall survival was 42.4 months and 34.0 months, respectively. The overall response rate was 56.1% for nab-paclitaxel and 52.5% for docetaxel. Adverse events in both treatment arms were similar to previous reports. Neutropenia was the most common adverse event in both arms, with 35.0% of patients in the nab-paclitaxel arm and 89.0% in the docetaxel arm experiencing grade 4 neutropenia. Grade 3 peripheral sensory neuropathy occurred in 22.0% of patients in the nab-paclitaxel and 5.0% in the docetaxel arm. In this study, although weekly nab-paclitaxel 150 mg/m2 did not show superiority in PFS compared with docetaxel, efficacy outcomes were similar in patients treated with weekly nab-paclitaxel and docetaxel.

    DOI: 10.1111/cas.13221

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  158. Safety Evaluation of Trastuzumab Emtansine in Japanese Patients with HER2-Positive Advanced Breast Cancer.

    Watanabe J, Ito Y, Saeki T, Masuda N, Takano T, Takao S, Nakagami K, Tsugawa K, Nakagawa S, Kanatani K, Nakayama T

    In vivo (Athens, Greece)   31 巻 ( 3 ) 頁: 493 - 500   2017年5月

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    記述言語:英語  

    DOI: 10.21873/invivo.11088

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  159. Circulating tumor cells as a prognostic marker for efficacy in the randomized phase III JO21095 trial in Japanese patients with HER2-negative metastatic breast cancer.

    Iwata H, Masuda N, Yamamoto D, Sagara Y, Sato N, Yamamoto Y, Saito M, Fujita T, Oura S, Watanabe J, Tsukabe M, Horiguchi K, Hattori S, Matsuura Y, Kuroi K

    Breast cancer research and treatment   162 巻 ( 3 ) 頁: 501 - 510   2017年4月

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  160. Comparison of an AC-taxane versus AC-free regimen and paclitaxel versus docetaxel in patients with lymph node-positive breast cancer: Final results of the National Surgical Adjuvant Study of Breast Cancer 02 trial, a randomized comparative phase 3 study.

    Watanabe T, Kuranami M, Inoue K, Masuda N, Aogi K, Ohno S, Iwata H, Mukai H, Uemura Y, Ohashi Y

    Cancer   123 巻 ( 5 ) 頁: 759 - 768   2017年3月

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    記述言語:英語  

    DOI: 10.1002/cncr.30421

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  161. Evaluation of ALDH1 expression in ipsilateral breast cancer recurrence.

    Shien T, Tanaka T, Tanabe M, Okumura Y, Masuda N, Yoshida A, Arima N, Komoike Y, Tanaka S, Iwase T, Taguchi T, Nakatsukasa K, Inaji H, Ishitobi M, Collaborative Study Group of, Scientific Research of the, Japanese Breast Cancer Society

    Oncology letters   13 巻 ( 3 ) 頁: 1071 - 1077   2017年3月

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    記述言語:英語  

    DOI: 10.3892/ol.2016.5538

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  162. A randomized, open-label, phase III trial comparing amrubicin versus docetaxel in patients with previously treated non-small-cell lung cancer

    Yoshioka H, Katakami N, Okamoto H, Iwamoto Y, Seto T, Takahashi T, Sunaga N, Kudoh S, Chikamori K, Harada M, Tanaka H, Saito H, Saka H, Takeda K, Nogami N, Masuda N, Harada T, Kitagawa H, Horio H, Yamanaka T, Fukuoka M, Yamamoto N, Nakagawa K

    Annals of Oncology   28 巻 ( 2 ) 頁: 285 - 291   2017年2月

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    記述言語:日本語   出版者・発行元:Annals of Oncology  

    Background: Amrubicin is approved for treating non-small-cell lung cancer (NSCLC) and small-cell lung cancer. However, no direct comparisons between amrubicin and docetaxel, a standard treatment for NSCLC, have been reported. Patients and methods: We conducted a randomized phase III trial of Japanese NSCLC patients after one or two chemotherapy regimens. Patients were randomized to amrubicin (35mg/m2 on days 1-3 every 3 weeks) or docetaxel (60mg/m2 on day 1 every 3 weeks). Outcomes included progression-free survival, overall survival, tumor responses, and safety. Results: Between October 2010 and June 2012, 202 patients were enrolled across 32 institutions. Median progression-free survival (3.6 versus 3.0 months; P=0.54) and overall survival (14.6 versus 13.5 months; P=0.86) were comparable in the amrubicin and docetaxel groups, respectively. The overall response rate was 14.4% (14/97) and 19.6% (19/97) in the amrubicin and docetaxel groups, respectively (P=0.45). The disease control rate was 55.7% in both groups. Adverse events occurred in all patients, and included grade ≥ 3 neutropenia occurred in 82.7% and 78.8% of patients in the amrubicin and docetaxel groups, respectively, grade ≥ 3 leukopenia occurred in 63.3% and 70.7%, and grade ≥ 3 febrile neutropenia occurred in 13.3% and 18.2% of patients in the amrubicin and docetaxel groups, respectively. Of eight cardiac-related events in the amrubicin group, three were considered related to amrubicin and resolved without treatment discontinuation. Conclusions: This was the first phase III study to compare amrubicin and docetaxel in patients with pretreated NSCLC. Amrubicin did not significantly improve the primary endpoint of PFS compared with docetaxel.

    DOI: 10.1093/annonc/mdw621

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  163. Efficacy and safety of low-dose capecitabine plus docetaxel versus single-agent docetaxel in patients with anthracycline-pretreated HER2-negative metastatic breast cancer: results from the randomized phase III JO21095 trial.

    Yamamoto D, Sato N, Rai Y, Yamamoto Y, Saito M, Iwata H, Masuda N, Oura S, Watanabe J, Hattori S, Matsuura Y, Kuroi K

    Breast cancer research and treatment   161 巻 ( 3 ) 頁: 473 - 482   2017年2月

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  164. Bevacizumab plus paclitaxel versus placebo plus paclitaxel as first-line therapy for HER2-negative metastatic breast cancer (MERiDiAN): A double-blind placebo-controlled randomised phase III trial with prospective biomarker evaluation.

    Miles D, Cameron D, Bondarenko I, Manzyuk L, Alcedo JC, Lopez RI, Im SA, Canon JL, Shparyk Y, Yardley DA, Masuda N, Ro J, Denduluri N, Hubeaux S, Quah C, Bais C, O'Shaughnessy J

    European journal of cancer (Oxford, England : 1990)   70 巻   頁: 146 - 155   2017年1月

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  165. Gemcitabine and Vinorelbine Combination Chemotherapy in Taxane-Pretreated Patients with Metastatic Breast Cancer: A Phase II Study of the Kinki Multidisciplinary Breast Oncology Group (KMBOG) 1015.

    Yamamura J, Masuda N, Yamamoto D, Tsuyuki S, Yamaguchi M, Tanaka S, Tsurutani J, Tokunaga S, Yoshidome K, Mizutani M, Aono T, Ooe A, Tanino H, Matsunami N, Yasojima H, Nakayama T, Nishida Y

    Chemotherapy   62 巻 ( 5 ) 頁: 307 - 313   2017年

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    記述言語:英語  

    DOI: 10.1159/000475879

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  166. Safety and pharmacokinetics of ramucirumab in combination with docetaxel in Japanese patients with locally advanced or metastatic breast cancer: a Phase Ib study.

    Masuda N, Iwata H, Aogi K, Xu Y, Ibrahim A, Gao L, Dalal R, Yoshikawa R, Sasaki Y

    Japanese journal of clinical oncology   46 巻 ( 12 ) 頁: 1088 - 1094   2016年12月

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    記述言語:英語  

    DOI: 10.1093/jjco/hyw127

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  167. Clinicopathological factors predicting early and late distant recurrence in estrogen receptor-positive, HER2-negative breast cancer

    Yamashita H, Ogiya A, Shien T, Horimoto Y, Masuda N, Inao T, Osako T, Takahashi M, Endo Y, Hosoda M, Ishida N, Horii R, Yamazaki K, Miyoshi Y, Yasojima H, Tomioka N, Collaborative Study Group of, Scientific Research of the, Japanese Breast Cancer Society

    Breast Cancer   23 巻 ( 6 ) 頁: 830 - 843   2016年11月

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    記述言語:日本語   出版者・発行元:Breast Cancer  

    Background: Most studies analyzing prognostic factors for late relapse have been performed in postmenopausal women who received tamoxifen or aromatase inhibitors as adjuvant endocrine therapy for estrogen receptor (ER)-positive breast cancer. Methods: A total of 223 patients (108 premenopausal and 115 postmenopausal) with early distant recurrence and 149 patients (62 premenopausal and 87 postmenopausal) with late distant recurrence of ER-positive, HER2-negative breast cancer who were given their initial treatment between 2000 and 2004 were registered from nine institutions. For each late recurrence patient, approximately two matched control patients without relapse for more than 10 years were selected. Clinicopathological factors and adjuvant therapies were compared among the three groups by menopausal status and age. Results: Factors predicting early recurrence in premenopausal women were large tumor size, high lymph node category and high tumor grade, whereas predictors for late recurrence were large tumor size and high lymph node category. In postmenopausal women under 60 years of age, factors predicting early recurrence were bilateral breast cancer, large tumor size, high lymph node category, low PgR expression and high Ki67 labeling index (LI), while predictors for late recurrence were large tumor size and high lymph node category. On the other hand, in postmenopausal women aged 60 years or older, factors predicting early recurrence were bilateral breast cancer, large tumor size, high lymph node category, high tumor grade, low ER expression and high Ki67 LI, whereas predictors for late recurrence were high lymph node category, low ER expression and short duration of adjuvant endocrine therapy. Conclusion: Predictors of early and late distant recurrence might differ according to menopausal status and age.

    DOI: 10.1007/s12282-015-0649-0

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  168. [A Case of Recurrent Breast Cancer with Adrenal Metastasis Resected Using Laparoscopic Surgery].

    Murakami H, Ohtani Y, Kinoshita T, Tanaka K, Yasojima H, Mizutani M, Nakamori S, Sekimoto M, Mori K, Mano M, Masuda N

    Gan to kagaku ryoho. Cancer & chemotherapy   43 巻 ( 12 ) 頁: 2035 - 2037   2016年11月

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    記述言語:日本語  

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  169. A Japanese prospective multi-institutional feasibility study on accelerated partial breast irradiation using interstitial brachytherapy: clinical results with a median follow-up of 26 months.

    Nose T, Otani Y, Asahi S, Tsukiyama I, Dokiya T, Saeki T, Fukuda I, Sekine H, Shikama N, Kumazaki Y, Takahashi T, Yoshida K, Kotsuma T, Masuda N, Yoden E, Nakashima K, Matsumura T, Nakagawa S, Tachiiri S, Moriguchi Y, Itami J, Oguchi M

    Breast cancer (Tokyo, Japan)   23 巻 ( 6 ) 頁: 861 - 868   2016年11月

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  170. [A Case of Recurrent Breast Cancer with Adrenal Metastasis Resected Using Laparoscopic Surgery].

    Murakami H, Ohtani Y, Kinoshita T, Tanaka K, Yasojima H, Mizutani M, Nakamori S, Sekimoto M, Mori K, Mano M, Masuda N

    Gan to kagaku ryoho. Cancer & chemotherapy   43 巻 ( 12 ) 頁: 2035 - 2037   2016年11月

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    記述言語:日本語  

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  171. Differences in expression of the cancer stem cell marker aldehyde dehydrogenase 1 among estrogen receptor-positive/human epidermal growth factor receptor type 2-negative breast cancer cases with early, late, and no recurrence

    Miyoshi Y, Shien T, Ogiya A, Ishida N, Yamazaki K, Horii R, Horimoto Y, Masuda N, Yasojima H, Inao T, Osako T, Takahashi M, Tomioka N, Endo Y, Hosoda M, Doihara H, Miyoshi S, Yamashita H

    Breast Cancer Research   18 巻 ( 1 ) 頁: 73   2016年7月

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    記述言語:日本語   出版者・発行元:Breast Cancer Research  

    Background: The significance of the expression of aldehyde dehydrogenase 1 (ALDH1), a cancer stem cell marker, for predicting the recurrence of estrogen receptor (ER)-positive/human epidermal growth factor receptor type 2 (HER2)-negative breast cancer is still poorly understood. The value of ALDH1 in predicting the time of recurrence remains unknown. Methods: In total, 184 patients with early distant recurrence, 134 patients with late distant recurrence, and 321 control patients without recurrence for more than 10 years after starting initial treatment for ER-positive/HER2-negative breast cancer, registered in 9 institutions, were analyzed. We assessed relationships between ALDH1 and other clinicopathological features, and ALDH1 expression was compared among the three groups. The relationship between ALDH1 expression and overall survival after recurrence was also evaluated in each group. Results: The rates of ALDH1 expression positivity (more than 1 %) in the early, late, and no recurrence groups were 18.4 %, 13.4 %, and 8.4 %, respectively. ALDH1 expression correlated significantly with lymph node metastases (p = 0.048) and the Ki-67 labeling index (p < 0.001) in the early recurrence group. Multivariate analysis revealed ALDH1 expression to be significantly higher in the early recurrence group than in the no recurrence group (adjusted OR 2.140, 95 % CI 1.144-4.003, p = 0.016). Moreover, there was a significant difference in ALDH1 expression between the early and no recurrence groups receiving adjuvant endocrine therapy and chemotherapy (adjusted OR 4.625, 95 % CI 1.881-12.474, p < 0.001). However, there was no difference in ALDH1 expression between the late and no recurrence groups in univariate analysis (OR 1.507, 95 % CI 0.738-2.998, p = 0.253). In multivariate analysis, ALDH1 was not a factor independently predicting overall survival after the detection of recurrence (adjusted OR 1.451, 95 % CI 0.985-2.085, p = 0.059). Conclusions: Among patients with ER-positive/HER2-negative breast cancer, ALDH1 expression was more common in those with early recurrence, and this expression was found to be associated with a more aggressive breast cancer phenotype than that in the patients without recurrence. Further study is needed to clarify the prognostic significance of the heterogeneity of cancer stem cells and to confirm their role in resistance to chemotherapy.

    DOI: 10.1186/s13058-016-0731-3

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  172. Extended Clavien-Dindo classification of surgical complications: Japan Clinical Oncology Group postoperative complications criteria.

    Katayama H, Kurokawa Y, Nakamura K, Ito H, Kanemitsu Y, Masuda N, Tsubosa Y, Satoh T, Yokomizo A, Fukuda H, Sasako M

    Surgery today   46 巻 ( 6 ) 頁: 668 - 85   2016年6月

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  173. A multicenter Phase II study evaluating the efficacy, safety and pharmacokinetics of trastuzumab emtansine in Japanese patients with heavily pretreated HER2-positive locally recurrent or metastatic breast cancer.

    Kashiwaba M, Ito Y, Takao S, Doihara H, Rai Y, Kanatani K, Takashima S, Masuda N

    Japanese journal of clinical oncology   46 巻 ( 5 ) 頁: 407 - 14   2016年5月

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    記述言語:英語  

    DOI: 10.1093/jjco/hyw013

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  174. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial.

    Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D

    The Lancet. Oncology   17 巻 ( 4 ) 頁: 425 - 439   2016年4月

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  175. Clinical significance of the expression of autophagy-associated marker, beclin 1, in breast cancer patients who received neoadjuvant endocrine therapy.

    Ueno T, Saji S, Sugimoto M, Masuda N, Kuroi K, Sato N, Takei H, Yamamoto Y, Ohno S, Yamashita H, Hisamatsu K, Aogi K, Iwata H, Imoto S, Sasano H, Toi M

    BMC cancer   16 巻   頁: 230   2016年3月

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  176. Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

    Chan A, Delaloge S, Holmes FA, Moy B, Iwata H, Harvey VJ, Robert NJ, Silovski T, Gokmen E, von Minckwitz G, Ejlertsen B, Chia SKL, Mansi J, Barrios CH, Gnant M, Buyse M, Gore I, Smith J, Harker G, Masuda N, Petrakova K, Zotano AG, Iannotti N, Rodriguez G, Tassone P, Wong A, Bryce R, Ye Y, Yao B, Martin M, ExteNET Study Group

    The Lancet. Oncology   17 巻 ( 3 ) 頁: 367 - 377   2016年3月

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  177. Correlative Analysis of Genetic Alterations and Everolimus Benefit in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From BOLERO-2.

    Hortobagyi GN, Chen D, Piccart M, Rugo HS, Burris HA, Pritchard KI, Campone M, Noguchi S, Perez AT, Deleu I, Shtivelband M, Masuda N, Dakhil S, Anderson I, Robinson DM, He W, Garg A, McDonald ER, Bitter H, Huang A, Taran T, Bachelot T, Lebrun F, Lebwohl D, Baselga J

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology   34 巻 ( 5 ) 頁: 419 - 26   2016年2月

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  178. Evaluation of the Clinical Utility of the ICG Fluorescence Method Compared with the Radioisotope Method for Sentinel Lymph Node Biopsy in Breast Cancer.

    Sugie T, Kinoshita T, Masuda N, Sawada T, Yamauchi A, Kuroi K, Taguchi T, Bando H, Yamashiro H, Lee T, Shinkura N, Kato H, Ikeda T, Yoshimura K, Ueyama H, Toi M

    Annals of surgical oncology   23 巻 ( 1 ) 頁: 44 - 50   2016年1月

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  179. Stratifying the outcome after neoadjuvant treatment using pathological response classification by the Japanese Breast Cancer Society.

    Mukai H, Arihiro K, Shimizu C, Masuda N, Miyagi Y, Yamaguchi T, Yoshida T

    Breast cancer (Tokyo, Japan)   23 巻 ( 1 ) 頁: 73 - 77   2016年1月

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  180. Clinicopathological Factors Related to the Prognosis of Metastatic Breast Cancer Patients after Development of Brain Metastasis.

    Yamamura J, Masuda N, Yasojima H, Mizutani M, Kuriyama K, Nakamori S, Sekimoto M, Mano M, Tanaka E, Nonaka M

    Breast care (Basel, Switzerland)   10 巻 ( 6 ) 頁: 387 - 92   2015年12月

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    記述言語:英語  

    DOI: 10.1159/000442192

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  181. Safety, pharmacokinetics and efficacy findings in an open-label, single-arm study of weekly paclitaxel plus lapatinib as first-line therapy for Japanese women with HER2-positive metastatic breast cancer.

    Inoue K, Kuroi K, Shimizu S, Rai Y, Aogi K, Masuda N, Nakayama T, Iwata H, Nishimura Y, Armour A, Sasaki Y

    International journal of clinical oncology   20 巻 ( 6 ) 頁: 1102 - 9   2015年12月

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  182. Comparison of different definitions of pathologic complete response in operable breast cancer: a pooled analysis of three prospective neoadjuvant studies of JBCRG.

    Kuroi K, Toi M, Ohno S, Nakamura S, Iwata H, Masuda N, Sato N, Tsuda H, Kurosumi M, Akiyama F

    Breast cancer (Tokyo, Japan)   22 巻 ( 6 ) 頁: 586 - 95   2015年11月

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  183. Unmet Information Needs and Quality of Life in Young Breast Cancer Survivors in Japan.

    Miyashita M, Ohno S, Kataoka A, Tokunaga E, Masuda N, Shien T, Kawabata K, Takahashi M

    Cancer nursing   38 巻 ( 6 ) 頁: E1 - 11   2015年11月

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  184. Dose response of pegfilgrastim in Japanese breast cancer patients receiving six cycles of docetaxel, doxorubicin, and cyclophosphamide therapy: a randomized controlled trial.

    Masuda N, Tokuda Y, Nakamura S, Shimazaki R, Ito Y, Tamura K

    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer   23 巻 ( 10 ) 頁: 2891 - 8   2015年10月

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  185. Phase I trial of afatinib plus vinorelbine in Japanese patients with advanced solid tumors, including breast cancer

    Mukai Hirofumi, Masuda Norikazu, Ishiguro Hiroshi, Mitsuma Ayako, Shibata Takashi, Yamamura Jun, Toi Masakazu, Watabe Aiko, Sarashina Akiko, Uttenreuther-Fischer Martina, Ando Yuichi

    CANCER CHEMOTHERAPY AND PHARMACOLOGY   76 巻 ( 4 ) 頁: 739 - 750   2015年10月

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    記述言語:日本語   出版者・発行元:Cancer Chemotherapy and Pharmacology  

    Purpose: This phase I trial assessed afatinib, an irreversible ErbB family blocker, plus vinorelbine in Japanese patients with advanced solid tumors not amenable to standard treatment. Methods: Primary objectives were evaluation of safety and the maximum tolerated dose (MTD) of once-daily (QD) afatinib plus weekly intravenous vinorelbine. Secondary objectives included pharmacokinetic assessments and preliminary efficacy. Dose finding utilized a 3 + 3 design, with a starting dose of afatinib 20 mg QD plus vinorelbine 25 mg/m2 weekly. Results: Seventeen patients were enrolled. Dose level 2 (afatinib 40 mg and vinorelbine 25 mg/m2) exceeded the MTD; dose-limiting toxicities (DLTs) were considered vinorelbine-related. Dose finding continued with modified dose levels; dose level 2a: afatinib 40 mg and a reduced dose of vinorelbine 20 mg/m2 and dose level 3: afatinib 40 mg and vinorelbine 25 mg/m2 allowing omission of vinorelbine for grade ≥2 neutropenia/thrombocytopenia and afatinib dose modification for adverse events (AEs). At dose level 3, 1/6 patients had a DLT (upper abdominal pain requiring afatinib dose reduction). Overall, the most frequent treatment-related AEs (any/grade 3 and 4) were: neutropenia (100/71 %), leukopenia (100/59 %), diarrhea (94/0 %), anemia (71/12 %) and stomatitis (65/0 %). Two patients with breast cancer achieved a partial response; eight patients (various cancer indications) had stable disease. Pharmacokinetic analyses suggested no relevant drug-drug interactions. Conclusions: Afatinib 40 mg QD plus vinorelbine 25 mg/m2 weekly was tolerated in Japanese patients when dose modifications for known AEs for either compound were allowed. Tumor shrinkage was also observed. This dose schedule was recommended for phase II/III trials in Japanese patients.

    DOI: 10.1007/s00280-015-2826-4

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  186. Intensive vs. Standard Post-Operative Surveillance in High-Risk Breast Cancer Patients (INSPIRE): Japan Clinical Oncology Group Study JCOG1204

    Hojo T, Masuda N, Mizutani T, Shibata T, Kinoshita T, Tamura K, Hara F, Fujisawa T, Inoue K, Saji S, Nakamura K, Fukuda H, Iwata H

    Japanese Journal of Clinical Oncology   45 巻 ( 10 ) 頁: 983 - 986   2015年10月

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    記述言語:日本語   出版者・発行元:Japanese Journal of Clinical Oncology  

    This Phase III trial aims to determine the superiority of intensive follow-up to standard follow-up in terms of overall survival in high-risk breast cancer patients, who are expected to have recurrence rates of over 30% within 5 years after surgery. Eligible patients are randomized either to the intensive follow-up group or to the standard follow-up group; the former will undergo physical examination, bone scintigraphy, chest computed tomography, abdominal computed tomography, brain magnetic resonance imaging/computed tomography and frequent tumor marker evaluations, whereas the latter will undergo physical examination at the same frequency and tumor markers will be evaluated once a year. Mammography once a year is planned for both groups. The primary endpoint is overall survival. Patient accrual was started in November 2013. A total of 1700 patients will be enrolled for 3 years and followed up for 7 years after closure of accrual. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000012429.

    DOI: 10.1093/jjco/hyv110

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  187. Prognostic significance of subtype and pathologic response in operable breast cancer; a pooled analysis of prospective neoadjuvant studies of JBCRG.

    Kuroi K, Toi M, Ohno S, Nakamura S, Iwata H, Masuda N, Sato N, Tsuda H, Kurosumi M, Akiyama F

    Breast cancer (Tokyo, Japan)   22 巻 ( 5 ) 頁: 486 - 95   2015年9月

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  188. Erratum to: Outcomes of trastuzumab therapy in HER2‑positive early breast cancer patients.

    Yamshiro H, Iwata H, Masuda N, Yamamoto N, Nishimura R, Ohtani S, Sato N, Takahashi M, Kamio T, Yamazaki K, Saito T, Kato M, Lee T, Ohno S, Kuroi K, Takano T, Takada M, Yasuno S, Morita S, Toi M

    International journal of clinical oncology   20 巻 ( 4 ) 頁: 723 - 4   2015年8月

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  189. Outcomes of trastuzumab therapy in HER2-positive early breast cancer patients.

    Yamshiro H, Iwata H, Masuda N, Yamamoto N, Nishimura R, Ohtani S, Sato N, Takahashi M, Kamio T, Yamazaki K, Saito T, Kato M, Lee T, Ohno S, Kuroi K, Takano T, Takada M, Yasuno S, Morita S, Toi M

    International journal of clinical oncology   20 巻 ( 4 ) 頁: 709 - 22   2015年8月

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  190. A Japanese prospective multi-institutional feasibility study on accelerated partial breast irradiation using interstitial brachytherapy: treatment planning and quality assurance.

    Otani Y, Nose T, Dokiya T, Saeki T, Kumazaki Y, Asahi S, Tsukiyama I, Fukuda I, Sekine H, Shikama N, Takahashi T, Yoshida K, Kotsuma T, Masuda N, Yoden E, Nakashima K, Matsumura T, Nakagawa S, Tachiiri S, Moriguchi Y, Itami J, Oguchi M

    Radiation oncology (London, England)   10 巻   頁: 126   2015年6月

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  191. Development of breast cancer therapy: biomarker-driven and response-guided approaches in a neoadjuvant setting.

    Toi M, Masuda N, Ishiguro H, Saji S, Ohno S, Chow LW

    The International journal of biological markers   30 巻 ( 2 ) 頁: e252 - 3   2015年4月

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    記述言語:英語  

    DOI: 10.5301/jbm.5000136

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  192. The present state and perception of young women with breast cancer towards breast reconstructive surgery.

    Nozawa K, Ichimura M, Oshima A, Tokunaga E, Masuda N, Kitano A, Fukuuchi A, Shinji O

    International journal of clinical oncology   20 巻 ( 2 ) 頁: 324 - 31   2015年4月

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  193. Phase III placebo-controlled, double-blind, randomized trial of pegfilgrastim to reduce the risk of febrile neutropenia in breast cancer patients receiving docetaxel/cyclophosphamide chemotherapy.

    Kosaka Y, Rai Y, Masuda N, Takano T, Saeki T, Nakamura S, Shimazaki R, Ito Y, Tokuda Y, Tamura K

    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer   23 巻 ( 4 ) 頁: 1137 - 43   2015年4月

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  194. Efficacy, safety, pharmacokinetics and biomarker findings in patients with HER2-positive advanced or metastatic breast cancer treated with lapatinib in combination with capecitabine: results from 51 Japanese patients treated in a clinical study.

    Iwata H, Fujii H, Masuda N, Mukai H, Nishimura Y, Katsura K, Ellis CE, Gagnon RC, Nakamura S

    Breast cancer (Tokyo, Japan)   22 巻 ( 2 ) 頁: 192 - 200   2015年3月

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  195. [Everolimus plus exemestane in postmenopausal patients with estrogen-receptor-positive advanced breast cancer - Japanese subgroup analysis of BOLERO -2].

    Ito Y, Masuda N, Iwata H, Mukai H, Horiguchi J, Tokuda Y, Kuroi K, Mori A, Ohno N, Noguchi S

    Gan to kagaku ryoho. Cancer & chemotherapy   42 巻 ( 1 ) 頁: 67 - 75   2015年1月

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  196. Prognostic factors of HER2-positive breast cancer patients who develop brain metastasis: a multicenter retrospective analysis.

    Hayashi N, Niikura N, Masuda N, Takashima S, Nakamura R, Watanabe K, Kanbayashi C, Ishida M, Hozumi Y, Tsuneizumi M, Kondo N, Naito Y, Honda Y, Matsui A, Fujisawa T, Oshitanai R, Yasojima H, Yamauchi H, Saji S, Iwata H

    Breast cancer research and treatment   149 巻 ( 1 ) 頁: 277 - 84   2015年1月

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  197. [Everolimus plus exemestane in postmenopausal patients with estrogen-receptor-positive advanced breast cancer - Japanese subgroup analysis of BOLERO -2].

    Ito Y, Masuda N, Iwata H, Mukai H, Horiguchi J, Tokuda Y, Kuroi K, Mori A, Ohno N, Noguchi S

    Gan to kagaku ryoho. Cancer & chemotherapy   42 巻 ( 1 ) 頁: 67 - 75   2015年1月

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    記述言語:日本語  

    PubMed

  198. The cell cycle profiling-risk score based on CDK1 and 2 predicts early recurrence in node-negative, hormone receptor-positive breast cancer treated with endocrine therapy.

    Kim SJ, Masuda N, Tsukamoto F, Inaji H, Akiyama F, Sonoo H, Kurebayashi J, Yoshidome K, Tsujimoto M, Takei H, Masuda S, Nakamura S, Noguchi S

    Cancer letters   355 巻 ( 2 ) 頁: 217 - 23   2014年12月

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  199. [Therapeutic effect of rebamipide for oral mucositis associated with FEC therapy for breast cancer].

    Enami A, Masuda N, Yamamura J, Mizutani M, Yasojima H, Shikata A, Masaoka M, Takada S, Bamba N, Yamamoto M, Abe M, Makihara K

    Gan to kagaku ryoho. Cancer & chemotherapy   41 巻 ( 11 ) 頁: 1407 - 12   2014年11月

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  200. Repeat lumpectomy for ipsilateral breast tumor recurrence (IBTR) after breast-conserving surgery: the impact of radiotherapy on second IBTR.

    Ishitobi M, Okumura Y, Nishimura R, Nakatsukasa K, Tanabe M, Yoshida A, Masuda N, Shien T, Tanaka S, Komoike Y, Arima N, Taguchi T, Inaji H, Collaborative Study Group of, Scientific Research of the, Japanese Breast Cancer Society

    Breast cancer (Tokyo, Japan)   21 巻 ( 6 ) 頁: 754 - 60   2014年11月

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  201. Efficacy of everolimus with exemestane versus exemestane alone in Asian patients with HER2-negative, hormone-receptor-positive breast cancer in BOLERO-2.

    Noguchi S, Masuda N, Iwata H, Mukai H, Horiguchi J, Puttawibul P, Srimuninnimit V, Tokuda Y, Kuroi K, Iwase H, Inaji H, Ohsumi S, Noh WC, Nakayama T, Ohno S, Rai Y, Park BW, Panneerselvam A, El-Hashimy M, Taran T, Sahmoud T, Ito Y

    Breast cancer (Tokyo, Japan)   21 巻 ( 6 ) 頁: 703 - 14   2014年11月

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  202. Clinicopathological features of young patients (&lt;35 years of age) with breast cancer in a Japanese Breast Cancer Society supported study.

    Kataoka A, Tokunaga E, Masuda N, Shien T, Kawabata K, Miyashita M

    Breast cancer (Tokyo, Japan)   21 巻 ( 6 ) 頁: 643 - 50   2014年11月

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  203. [Therapeutic effect of rebamipide for oral mucositis associated with FEC therapy for breast cancer].

    Enami A, Masuda N, Yamamura J, Mizutani M, Yasojima H, Shikata A, Masaoka M, Takada S, Bamba N, Yamamoto M, Abe M, Makihara K

    Gan to kagaku ryoho. Cancer & chemotherapy   41 巻 ( 11 ) 頁: 1407 - 12   2014年11月

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    記述言語:日本語  

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  204. Observational study of axilla treatment for breast cancer patients with 1-3 positive micrometastases or macrometastases in sentinel lymph nodes.

    Oba MS, Imoto S, Toh U, Wada N, Kawada M, Kitada M, Masuda N, Taguchi T, Minami S, Jinno H, Sakamoto J, Morita S, Japanese Society for Sentinel Node, Navigation Surgery

    Japanese journal of clinical oncology   44 巻 ( 9 ) 頁: 876 - 9   2014年9月

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    記述言語:英語  

    DOI: 10.1093/jjco/hyu090

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  205. Evaluating the 21-gene assay Recurrence Score® as a predictor of clinical response to 24 weeks of neoadjuvant exemestane in estrogen receptor-positive breast cancer

    Ueno T, Masuda N, Yamanaka T, Saji S, Kuroi K, Sato N, Takei H, Yamamoto Y, Ohno S, Yamashita H, Hisamatsu K, Aogi K, Iwata H, Sasano H, Toi M

    International Journal of Clinical Oncology   19 巻 ( 4 ) 頁: 607 - 613   2014年8月

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    記述言語:日本語   出版者・発行元:International Journal of Clinical Oncology  

    Background: The aim of this study was to investigate the association between the results of the Recurrence Score (RS) assay and the clinical response to neoadjuvant endocrine therapy in postmenopausal women with breast cancer. Methods: Core biopsy samples at baseline and post-treatment surgical samples were obtained from 80 and 77 of 116 patients, respectively, enrolled in the multicenter prospective study of neoadjuvant exemestane therapy (JFMC34-0601). The 21-gene assay was performed after appropriate manual microdissection. The estrogen receptor (ER), progesterone receptor, HER2 and Ki-67 were assayed by immunohistochemistry at a central laboratory. Clinical response was assessed based on the RECIST (Response Evaluation Criteria In Solid Tumors) guideline. Results: Sixty-four core biopsy samples and 52 resection samples met the RS quality requirements. The clinical response rate in those patients with a low RS result (low RS group; 19/32, 59.4 %) was significantly higher than that in those patients with a high RS result (high RS group; 3/15, 20.0 %) (P = 0.015) and similar to that in patients with an intermediate RS result (intermediate RS group; 10/17, 58.8 %). The rates of breast-conserving surgery (BCS) were 90.6 % (29/32) in the low RS group, 76.5 % (13/17) in the intermediate RS group and 46.7 % (7/15) in the high RS group. The odds ratio for BCS adjusted for continuous baseline Ki-67 was 0.114 [95 % confidence interval (CI) 0.014-0.721; P = 0.028] between the high and low RS groups. RS values in pre-treatment samples were highly correlated with those in post-treatment samples (Spearman correlation coefficient 0.745, 95 % CI 0.592-0.846). Conclusion: Our results demonstrate the predictive value of the RS for clinical response to neoadjuvant exemestane therapy in postmenopausal women with ER-positive breast cancer. © 2013 Japan Society of Clinical Oncology.

    DOI: 10.1007/s10147-013-0614-x

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  206. Treatment outcomes and prognostic factors for patients with brain metastases from breast cancer of each subtype: a multicenter retrospective analysis.

    Niikura N, Hayashi N, Masuda N, Takashima S, Nakamura R, Watanabe K, Kanbayashi C, Ishida M, Hozumi Y, Tsuneizumi M, Kondo N, Naito Y, Honda Y, Matsui A, Fujisawa T, Oshitanai R, Yasojima H, Tokuda Y, Saji S, Iwata H

    Breast cancer research and treatment   147 巻 ( 1 ) 頁: 103 - 12   2014年8月

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  207. Phase II study of S-1 in combination with trastuzumab for HER2-positive metastatic breast cancer

    Takashima T, Nakayama T, Yoshidome K, Kawajiri H, Kamigaki S, Tsurutani J, Arai T, Ito T, Komoike Y, Doi T, Masuda N, Miyauchi K, Miyoshi Y, Sakamoto J, Morita S, Taguchi T

    Anticancer Research   34 巻 ( 7 ) 頁: 3583 - 3588   2014年7月

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    記述言語:日本語   出版者・発行元:Anticancer Research  

    Aim: We undertook a prospective phase II study to evaluate the efficacy of S-1 plus trastuzumab combination regimen for human epidermal-growth factor receptor-2 (HER2)-positive metastatic breast cancer (MBC). Patients and Methods: HER2-positive MBC patients received oral administration of S-1 (80 mg/m2/day, days 1 to 28, every 6 weeks) and intravenous weekly trastuzumab (2 mg/kg), according to the results of a prior Phase I trial of our group. Results: A total of 28 patients were enrolled and received a median of 3.5 (range 1-10) cycles of treatment. Overall response rate and clinical benefit rate were 53.6% and 75.0%, respectively. Progression-free survival was 30 weeks. With regard to grade 3 and 4 adverse effects, leucopenia, neutropenia, increase in serum alanine aminotransferase, and diarrhea were observed. Conclusion: Combination of S-1 and trastuzumab was tolerable and had excellent efficacy with good response and disease control in this trial.

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  208. Phase II study of S-1 in combination with trastuzumab for HER2-positive metastatic breast cancer

    Takashima T., Nakayama T., Yoshidome K., Kawajiri H., Kamigaki S., Tsurutani J., Arai T., Ito T., Komoike Y., Doi T., Masuda N., Miyauchi K., Miyoshi Y., Sakamoto J., Morita S., Taguchi T.

    Anticancer Research   34 巻 ( 7 ) 頁: 3583 - 3588   2014年7月

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    記述言語:日本語   出版者・発行元:Anticancer Research  

    Aim: We undertook a prospective phase II study to evaluate the efficacy of S-1 plus trastuzumab combination regimen for human epidermal-growth factor receptor-2 (HER2)-positive metastatic breast cancer (MBC). Patients and Methods: HER2-positive MBC patients received oral administration of S-1 (80 mg/m2/day, days 1 to 28, every 6 weeks) and intravenous weekly trastuzumab (2 mg/kg), according to the results of a prior Phase I trial of our group. Results: A total of 28 patients were enrolled and received a median of 3.5 (range 1-10) cycles of treatment. Overall response rate and clinical benefit rate were 53.6% and 75.0%, respectively. Progression-free survival was 30 weeks. With regard to grade 3 and 4 adverse effects, leucopenia, neutropenia, increase in serum alanine aminotransferase, and diarrhea were observed. Conclusion: Combination of S-1 and trastuzumab was tolerable and had excellent efficacy with good response and disease control in this trial.

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  209. Phase II study of S-1 in combination with trastuzumab for HER2-positive metastatic breast cancer.

    Takashima T, Nakayama T, Yoshidome K, Kawajiri H, Kamigaki S, Tsurutani J, Arai T, Ito T, Komoike Y, Doi T, Masuda N, Miyauchi K, Miyoshi Y, Sakamoto J, Morita S, Taguchi T

    Anticancer research   34 巻 ( 7 ) 頁: 3583 - 8   2014年7月

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  210. Phase II study of S-1 in combination with trastuzumab for HER2-positive metastatic breast cancer.

    Takashima T, Nakayama T, Yoshidome K, Kawajiri H, Kamigaki S, Tsurutani J, Arai T, Ito T, Komoike Y, Doi T, Masuda N, Miyauchi K, Miyoshi Y, Sakamoto J, Morita S, Taguchi T

    Anticancer research   34 巻 ( 7 ) 頁: 3583 - 8   2014年7月

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  211. Phase II Study of S-1 in Combination with Trastuzumab for HER2-positive Metastatic Breast Cancer

    Takashima Tsutomu, Nakayama Takahiro, Yoshidome Katsuhide, Kawajiri Hidemi, Kamigaki Shunji, Tsurutani Junji, Arai Takashi, Ito Toshikazu, Komoike Yoshihumi, Doi Takako, Masuda Norikazu, Miyauchi Keisuke, Miyoshi Yasuo, Sakamoto Junichi, Morita Satoshi, Taguchi Tetsuya

    ANTICANCER RESEARCH   34 巻 ( 7 ) 頁: 3583 - 3588   2014年7月

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    記述言語:日本語  

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  212. Phase II Study of S-1 in Combination with Trastuzumab for HER2-positive Metastatic Breast Cancer

    Takashima Tsutomu, Nakayama Takahiro, Yoshidome Katsuhide, Kawajiri Hidemi, Kamigaki Shunji, Tsurutani Junji, Arai Takashi, Ito Toshikazu, Komoike Yoshihumi, Doi Takako, Masuda Norikazu, Miyauchi Keisuke, Miyoshi Yasuo, Sakamoto Junichi, Morita Satoshi, Taguchi Tetsuya

    ANTICANCER RESEARCH   34 巻 ( 7 ) 頁: 3583 - 3588   2014年7月

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  213. Randomized phase II study of weekly paclitaxel with and without carboplatin followed by cyclophosphamide/epirubicin/5-fluorouracil as neoadjuvant chemotherapy for stage II/IIIA breast cancer without HER2 overexpression.

    Ando M, Yamauchi H, Aogi K, Shimizu S, Iwata H, Masuda N, Yamamoto N, Inoue K, Ohono S, Kuroi K, Hamano T, Sukigara T, Fujiwara Y

    Breast cancer research and treatment   145 巻 ( 2 ) 頁: 401 - 9   2014年6月

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  214. Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): a randomised, double-blind, placebo-controlled phase 3 trial.

    André F, O'Regan R, Ozguroglu M, Toi M, Xu B, Jerusalem G, Masuda N, Wilks S, Arena F, Isaacs C, Yap YS, Papai Z, Lang I, Armstrong A, Lerzo G, White M, Shen K, Litton J, Chen D, Zhang Y, Ali S, Taran T, Gianni L

    The Lancet. Oncology   15 巻 ( 6 ) 頁: 580 - 91   2014年5月

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  215. Phase III randomized trial of toremifene versus tamoxifen for Japanese postmenopausal patients with early breast cancer.

    Kimura M, Tominaga T, Kimijima I, Takatsuka Y, Takashima S, Nomura Y, Kasumi F, Yamaguchi A, Masuda N, Noguchi S, Eshima N

    Breast cancer (Tokyo, Japan)   21 巻 ( 3 ) 頁: 275 - 83   2014年5月

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  216. [Effect of oral dexamethasone given 24 hours previously on docetaxel-induced edema: a retrospective study].

    Kato A, Masuda N, Makihara K, Ueno H, Hirohata K, Yamauchi K, Yasojima H, Mizutani M, Yamamura J, Komori K

    Gan to kagaku ryoho. Cancer & chemotherapy   41 巻 ( 2 ) 頁: 211 - 4   2014年2月

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  217. Everolimus plus exemestane as first-line therapy in HR⁺, HER2⁻ advanced breast cancer in BOLERO-2.

    Beck JT, Hortobagyi GN, Campone M, Lebrun F, Deleu I, Rugo HS, Pistilli B, Masuda N, Hart L, Melichar B, Dakhil S, Geberth M, Nunzi M, Heng DY, Brechenmacher T, El-Hashimy M, Douma S, Ringeisen F, Piccart M

    Breast cancer research and treatment   143 巻 ( 3 ) 頁: 459 - 67   2014年2月

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  218. [Effect of oral dexamethasone given 24 hours previously on docetaxel-induced edema: a retrospective study].

    Kato A, Masuda N, Makihara K, Ueno H, Hirohata K, Yamauchi K, Yasojima H, Mizutani M, Yamamura J, Komori K

    Gan to kagaku ryoho. Cancer & chemotherapy   41 巻 ( 2 ) 頁: 211 - 4   2014年2月

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  219. Primary chest wall abscess mimicking a breast tumor that occurred after blunt chest trauma: a case report.

    Yamaoka Y, Yamamura J, Masuda N, Yasojima H, Mizutani M, Nakamori S, Kanazawa T, Kuriyama K, Mano M, Sekimoto M

    Case reports in medicine   2014 巻   頁: 620876   2014年

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    DOI: 10.1155/2014/620876

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  220. Phase I trial of afatinib plus vinorelbine in Japanese patients with advanced solid tumors including breast cancer

    Masuda N., Mukai H., Ishiguro H., Mitsuma A., Shibata T., Yamamura J., Toi M., Watabe A., Sarashina A., Ebisawa R., Uttenreuther-Fischer M., Ando Y.

    CANCER RESEARCH   73 巻   2013年12月

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  221. Absence of pharmacokinetic drug-drug interaction of pertuzumab with trastuzumab and docetaxel.

    Cortés J, Swain SM, Kudaba I, Hauschild M, Patel T, Grincuka E, Masuda N, McNally V, Ross G, Brewster M, Marier JF, Trinh MM, Garg A, Nijem I, Visich J, Lum BL, Baselga J

    Anti-cancer drugs   24 巻 ( 10 ) 頁: 1084 - 92   2013年11月

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  222. Randomized trial of preoperative docetaxel with or without capecitabine after 4 cycles of 5-fluorouracil-epirubicin-cyclophosphamide (FEC) in early-stage breast cancer: Exploratory analyses identify Ki67 as a predictive biomarker for response to neoadjuvant chemotherapy

    Ohno S, Chow L.W.C, Sato N, Masuda N, Sasano H, Takahashi F, Bando H, Iwata H, Morimoto T, Kamigaki S, Nakayama T, Nakamura S, Kuroi K, Aogi K, Kashiwaba M, Yamashita H, Hisamatsu K, Ito Y, Yamamoto Y, Ueno T, Fakhrejahani E, Yoshida N, Toi M

    Breast Cancer Research and Treatment   142 巻 ( 1 ) 頁: 69 - 80   2013年11月

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    記述言語:日本語   出版者・発行元:Breast Cancer Research and Treatment  

    This randomized, multicenter study compared the efficacy of docetaxel with or without capecitabine following fluorouracil/epirubicin/cyclophosphamide (FEC) therapy in operable breast cancer and investigated the role of Ki67 as a predictive biomarker. Patients were randomized to 4 cycles of docetaxel/capecitabine (docetaxel: 75 mg/m2 on day 1; capecitabine: 1,650 mg/m2 on days 1-14 every 3 weeks) or docetaxel alone (75 mg/m2 on day 1 every 3 weeks) after completion of 4 cycles of FEC (5-fluorouracil 500 mg/m2, epirubicin 100 mg/m2 and cyclophosphamide 500 mg/m2 on day 1 every 3 weeks). The primary endpoint was the pathological complete response (pCR) rate. Predictive factor analysis was conducted using clinicopathological markers, including hormone receptors and Ki67 labeling index (Ki67LI). A total of 477 patients were randomized; the overall response in the docetaxel/capecitabine and docetaxel groups was 88.3 and 87.4 %, respectively. There were no significant differences in the pCR rate (docetaxel/capecitabine: 23 %; docetaxel: 24 %; p = 0.748), disease-free survival, or overall survival. However, patients with mid-range Ki67LI (10-20 %) showed a trend towards improved pCR rate with docetaxel/capecitabine compared to docetaxel alone. Furthermore, multivariate logistic regression analysis showed pre-treatment Ki67LI (odds ratio 1.031; 95 % CI 1.014-1.048; p = 0.0004) to be a significant predictor of pCR in this neoadjuvant treatment setting. Docetaxel/capecitabine (after 4 cycles of FEC) did not generate significant improvement in pCR compared to docetaxel alone. However, exploratory analyses suggested that assessment of pre-treatment Ki67LI may be a useful tool in the identification of responders to preoperative docetaxel/capecitabine in early-stage breast cancer. © 2013 The Author(s).

    DOI: 10.1007/s10549-013-2691-y

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  223. The efficacy and safety of FSK0808, filgrastim biosimilar: a multicenter, non-randomized study in Japanese patients with breast cancer.

    Sagara Y, Sato K, Fukuma E, Higaki K, Mizutani M, Osaki A, Takano T, Tokuda Y, Ohno S, Masuda N, Suzuki M, Saeki T

    Japanese journal of clinical oncology   43 巻 ( 9 ) 頁: 865 - 73   2013年9月

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    記述言語:英語  

    DOI: 10.1093/jjco/hyt091

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  224. A multicenter, phase II study of epirubicin/cyclophosphamide followed by docetaxel and concurrent trastuzumab as primary systemic therapy for HER-2 positive advanced breast cancer (the HER2NAT study).

    Aogi K, Saeki T, Nakamura S, Kashiwaba M, Sato N, Masuda N, Rai Y, Ohno S, Kuroi K, Nishimura R, Miyakoda K, Akiyama F, Kurosumi M, Ikeda T

    International journal of clinical oncology   18 巻 ( 4 ) 頁: 598 - 606   2013年8月

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  225. Probiotic Beverage with Soy Isoflavone Consumption for Breast Cancer Prevention: A Case-control Study.

    Toi M, Hirota S, Tomotaki A, Sato N, Hozumi Y, Anan K, Nagashima T, Tokuda Y, Masuda N, Ohsumi S, Ohno S, Takahashi M, Hayashi H, Yamamoto S, Ohashi Y

    Current nutrition and food science   9 巻 ( 3 ) 頁: 194 - 200   2013年8月

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  226. A randomized, double-blind, controlled study of exemestane versus anastrozole for the first-line treatment of postmenopausal Japanese women with hormone-receptor-positive advanced breast cancer

    Iwata H, Masuda N, Ohno S, Rai Y, Sato Y, Ohsumi S, Hashigaki S, Nishizawa Y, Hiraoka M, Morimoto T, Sasano H, Saeki T, Noguchi S

    Breast Cancer Research and Treatment   139 巻 ( 2 ) 頁: 441 - 451   2013年6月

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    記述言語:日本語   出版者・発行元:Breast Cancer Research and Treatment  

    The aromatase inhibitors exemestane and anastrozole are approved in Japan for first-line treatment of postmenopausal patients with advanced, hormone-receptor-positive breast cancer. This phase 3, randomized, double-blind study directly compared time to progression (TTP) for exemestane and anastrozole therapy in this patient population. Eligible patients were randomized to receive exemestane 25 mg or anastrozole 1 mg, each once daily. The primary endpoint was TTP based on assessment by an expert radiologic images review committee (ERIRC). Secondary endpoints included investigator-assessed TTP, time to treatment failure, overall survival, objective response rate, clinical benefit rate, and safety. A total 298 patients were randomized to receive exemestane (n = 149; mean age 63.4 years) or anastrozole (n = 149; mean age 64.0 years). Median ERIRC-assessed TTP was 13.8 and 11.1 months (hazard ratio = 1.007; 95 % confidence interval [CI]: 0.771, 1.317) and median investigator-assessed TTP was 13.8 and 13.7 months (hazard ratio = 1.059; 95 % CI: 0.816, 1.374) in the exemestane and anastrozole arms, respectively. Median overall survival was 60.1 months in the anastrozole arm and was not reached in the exemestane arm at data cutoff. The objective response rate was 43.9 % (95 % CI: 35.3, 52.8) and 39.1 % (95 % CI: 30.6, 48.1) in the exemestane and anastrozole arms, respectively. Treatment-related adverse events grade ≥3 occurred in 9.4 and 6.0 % of patients, and treatment-related serious adverse events occurred in 4.0 and 3.4 % of patients in the exemestane and anastrozole arms, respectively. In this study, the efficacy and safety profiles of exemestane were similar to those of anastrozole in Japanese patients with advanced, hormone-receptor-positive breast cancer; however, TTP non-inferiority of exemestane versus anastrozole was not confirmed. © 2013 The Author(s).

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  227. Breast cancer subtype and distant recurrence after ipsilateral breast tumor recurrence.

    Ishitobi M, Okumura Y, Arima N, Yoshida A, Nakatsukasa K, Iwase T, Shien T, Masuda N, Tanaka S, Tanabe M, Tanaka T, Komoike Y, Taguchi T, Nishimura R, Inaji H

    Annals of surgical oncology   20 巻 ( 6 ) 頁: 1886 - 92   2013年6月

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  228. Efficacy and safety of ixabepilone in taxane-resistant patients with metastatic breast cancer previously treated with anthracyclines: results of a phase II study in Japan.

    Aogi K, Rai Y, Ito Y, Masuda N, Watanabe J, Horiguchi J, Tokudome T, Takashima S

    Cancer chemotherapy and pharmacology   71 巻 ( 6 ) 頁: 1427 - 33   2013年6月

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  229. Novel effect of 2-aminoethoxydiphenylborate through inhibition of calcium sensitization induced by Rho kinase activation in human detrusor smooth muscle

    Shahab Nouval, Kajioka Shunichi, Takahashi Ryosuke, Hayashi Maya, Nakayama Shinsuke, Sakamoto Kazuyuki, Takeda Masahiro, Masuda Noriyuki, Naito Seiji

    EUROPEAN JOURNAL OF PHARMACOLOGY   708 巻 ( 1-3 ) 頁: 14 - 20   2013年5月

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    記述言語:日本語   出版者・発行元:European Journal of Pharmacology  

    Since the introduction of 2-aminoethoxydiphenylborate (2-APB) as a membrane permeable modulator of inositol (1,4,5)-trisphosphate receptors, subsequent studies have revealed additional actions of this chemical on multiple Ca 2+-permeable ionic channels in the plasma membrane. However, no reports have yet examined 2-APB as a modulator targeting contractile machinery in smooth muscle, independent of Ca2+ mobilization, namely Ca 2+ sensitization. Here, we assessed whether or not 2-APB affects intracellular signaling pathways of Ca2+ sensitization for contraction using α-toxin permeabilized human detrusor smooth muscle. Although contractions were induced by application of Ca2+-containing bath solutions, 2-APB had little effect on contractions induced by 1 μM Ca2+ alone but significantly reversed the carbachol-induced augmentation of Ca2+-induced contraction in the presence of guanosine triphosphate (carbachol-induced Ca2+ sensitization). The rho kinase inhibitor Y-27632 and protein kinase C inhibitor GF-109203X also reversed the carbachol-mediated Ca2+ sensitization. Additional application of 2-APB caused a small but significant further attenuation of the contraction in the presence of GF-109203X but not in the presence of Y-27632. Like carbachol, the rho kinase activator; sphingosylphosphorylcholine, protein kinase C activator; phorbol 12,13 dibutyrate, and myosin light chain phosphatase inhibitor; calyculin-A all induced Ca2+ sensitization. However, the inhibitory activity of 2-APB was limited with sphingosylphosphorylcholine- induced Ca2+ sensitization. This study revealed a novel inhibitory effect of 2-APB on smooth muscle contractility through inhibition of the rho kinase pathway. © 2013 Elsevier B.V.

    DOI: 10.1016/j.ejphar.2013.03.006

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  230. Phase II study of bi-weekly irinotecan for patients with previously treated HER2-negative metastatic breast cancer : KMBOG0610B

    HAYASHI Hidetoshi, TSURUTANI Junji, SATOH Taro, MASUDA Norikazu, OKAMOTO Wataru, MORINAGA Ryotaro, TERASHIMA Masaaki, MIYAZAKI Masaki, OKAMOTO Isamu, NISHIDA Yukihiro, TOMINAGA Shusei, TOKUNAGA Yukihiko, YAMAGUCHI Masahide, SAKAMOTO Junichi, NAKAYAMA Takahiro, NAKAGAWA Kazuhiko

      20 巻 ( 2 ) 頁: 131 - 136   2013年4月

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  231. Phase II study of bi-weekly irinotecan for patients with previously treated HER2-negative metastatic breast cancer : KMBOG0610B

    HAYASHI Hidetoshi, TSURUTANI Junji, SATOH Taro, MASUDA Norikazu, OKAMOTO Wataru, MORINAGA Ryotaro, TERASHIMA Masaaki, MIYAZAKI Masaki, OKAMOTO Isamu, NISHIDA Yukihiro, TOMINAGA Shusei, TOKUNAGA Yukihiko, YAMAGUCHI Masahide, SAKAMOTO Junichi, NAKAYAMA Takahiro, NAKAGAWA Kazuhiko

      20 巻 ( 2 ) 頁: 131 - 136   2013年4月

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  232. Phase II study of bi-weekly irinotecan for patients with previously treated HER2-negative metastatic breast cancer: KMBOG0610B

    Hayashi Hidetoshi, Tsurutani Junji, Satoh Taro, Masuda Norikazu, Okamoto Wataru, Morinaga Ryotaro, Terashima Masaaki, Miyazaki Masaki, Okamoto Isamu, Nishida Yukihiro, Tominaga Shusei, Tokunaga Yukihiko, Yamaguchi Masahide, Sakamoto Junichi, Nakayama Takahiro, Nakagawa Kazuhiko

    BREAST CANCER   20 巻 ( 2 ) 頁: 131 - 136   2013年4月

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    記述言語:日本語   出版者・発行元:Breast Cancer  

    Background: A trial was conducted to evaluate the feasibility, efficacy, and safety of biweekly administration of irinotecan, a novel topoisomerase I inhibitor, for patients with metastatic breast cancer (MBC) previously treated with either anthracycline-based or taxane-based chemotherapy. Methods: Eligible patients were HER2-negative, had a performance status of 0 to 2, and had been treated previously with either anthracyclines or taxanes for MBC. Patients received irinotecan intravenously at 150 mg/m2 on days 1 and 15 every 4 weeks. The primary end-point was feasibility, and the treatment was considered feasible if a patient was able to receive three administrations of irinotecan within the first 8 weeks, as pre-specified in the protocol. Results: Eighteen patients (median age 60 years) were enrolled. Fifteen patients received irinotecan more than 3 times within the first 8 weeks, with resulting feasibility of 83.3%. The median number of treatment cycles was 2 (range 1-16) during this period, and the relative dose intensity was 91.2%. Partial response was observed for one patient, so overall response rate was 5.6%. Nine patients (50.0%) had stable disease, and overall disease control was 50.0%. Median progression-free survival and overall survival periods were 3.2 and 9.6 months, respectively. The only grade 3/4 hematological toxicity was neutropenia (22.2%). Grade 3/4 non-hematological toxicities were anorexia (11.2%), diarrhea (11.2%), and fatigue (5.6%). No treatment-related death occurred. Conclusions: This study demonstrated that biweekly administration of 150 mg/m2 irinotecan was feasible for patients with MBC treated previously with anthracyclines or taxanes. © 2011 The Japanese Breast Cancer Society.

    DOI: 10.1007/s12282-011-0316-z

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  233. Low dose capecitabine plus weekly paclitaxel in patients with metastatic breast cancer: a multicenter phase II study KBCSG-0609

    Taguchi Tetsuya, Yamamoto Daigo, Masuda Norikazu, Oba Koji, Nakayama Takahiro, Nagata Takuya, Nomura Masaya, Yoshidome Katsuhide, Yoshino Hiroshi, Matsunami Nobuki, Miyashita Masaru, Furuya Yoshihiko, Ishida Takanori, Wakita Kazuyuki, Sakamoto Junichi, Noguchi Shinzaburo

    CANCER CHEMOTHERAPY AND PHARMACOLOGY   71 巻 ( 3 ) 頁: 741 - 747   2013年3月

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    記述言語:日本語   出版者・発行元:Cancer Chemotherapy and Pharmacology  

    Purpose: The combination of capecitabine and paclitaxel (XP) has demonstrated synergistic antitumor activity in preclinical models. The purpose of this phase II study was to evaluate the efficacy and safety of a monthly XP regimen in patients with metastatic breast cancer (MBC). Methods: Eligible patients had received one or fewer prior chemotherapy regimens for MBC. Patients received oral capecitabine of low dose (828 mg/m2 twice daily, days 1-21) plus paclitaxel (80 mg/m2, i.v., over 60 min, days 1, 8 and 15) every 28 days until disease progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR). Progression-free survival (PFS), overall survival (OS) and safety were secondary endpoints. An exploratory analysis of efficacy according to hormone receptor (HR) status was performed. Results: Forty-four patients were enrolled, and 43 patients were evaluable. ORR was 46.5 %. PFS and OS were 8.3 and 22.9 months, respectively. ORR was 45.5 % in patients with HR-positive tumors and 50 % in HR-negative cases. The most frequently observed grade 3/4 adverse events were neutropenia (27.9 %), leukopenia (11.6 %), hand-foot syndrome (HFS, 9.3 %) and fatigue (7.0 %). There were no discontinuations due to HFS. Conclusions: Monthly XP was an effective and well-tolerated regimen for the first- or second-line treatment for MBC. © 2013 Springer-Verlag Berlin Heidelberg.

    DOI: 10.1007/s00280-012-2068-7

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  234. Analysis of Ki-67 expression with neoadjuvant anastrozole or tamoxifen in patients receiving goserelin for premenopausal breast cancer.

    Iwata H, Masuda N, Sagara Y, Kinoshita T, Nakamura S, Yanagita Y, Nishimura R, Iwase H, Kamigaki S, Takei H, Tsuda H, Hayashi N, Noguchi S

    Cancer   119 巻 ( 4 ) 頁: 704 - 13   2013年2月

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    DOI: 10.1002/cncr.27818

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  235. Pain outcomes in patients with advanced breast cancer and bone metastases: results from a randomized, double-blind study of denosumab and zoledronic acid.

    Cleeland CS, Body JJ, Stopeck A, von Moos R, Fallowfield L, Mathias SD, Patrick DL, Clemons M, Tonkin K, Masuda N, Lipton A, de Boer R, Salvagni S, Oliveira CT, Qian Y, Jiang Q, Dansey R, Braun A, Chung K

    Cancer   119 巻 ( 4 ) 頁: 832 - 8   2013年2月

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    DOI: 10.1002/cncr.27789

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  236. Final results of a safety and efficacy trial of preoperative sequential chemoradiation therapy for the nonsurgical treatment of early breast cancer: Japan Clinical Oncology Group Study JCOG0306.

    Mukai H, Watanabe T, Mitsumori M, Tsuda H, Nakamura S, Masuda N, Yamamoto N, Shibata T, Sato A, Iwata H, Aogi K

    Oncology   85 巻 ( 6 ) 頁: 336 - 41   2013年

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    DOI: 10.1159/000355196

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  237. [Current situation and issues regarding preoperative chemotherapy for HER2-positive breast cancer].

    Mizutani M, Masuda N, Abe H, Yamamura J, Yasojima H, Kodama Y, Umeda T, Kurumi Y, Mano M, Tani T

    Gan to kagaku ryoho. Cancer & chemotherapy   39 巻 ( 13 ) 頁: 2521 - 6   2012年12月

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  238. [Current situation and issues regarding preoperative chemotherapy for HER2-positive breast cancer].

    Mizutani M, Masuda N, Abe H, Yamamura J, Yasojima H, Kodama Y, Umeda T, Kurumi Y, Mano M, Tani T

    Gan to kagaku ryoho. Cancer & chemotherapy   39 巻 ( 13 ) 頁: 2521 - 6   2012年12月

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    PubMed

  239. A randomized controlled trial comparing primary tumour resection plus systemic therapy with systemic therapy alone in metastatic breast cancer (PRIM-BC): Japan Clinical Oncology Group Study JCOG1017.

    Shien T, Nakamura K, Shibata T, Kinoshita T, Aogi K, Fujisawa T, Masuda N, Inoue K, Fukuda H, Iwata H

    Japanese journal of clinical oncology   42 巻 ( 10 ) 頁: 970 - 3   2012年10月

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    記述言語:英語  

    DOI: 10.1093/jjco/hys120

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  240. [Current activities and perspective of JBCRG (Japan Breast Cancer Research Group)].

    Masuda N, Toi M, Kuroi K

    Nihon rinsho. Japanese journal of clinical medicine   70 Suppl 7 巻   頁: 763 - 72   2012年9月

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  241. [Current activities and perspective of JBCRG (Japan Breast Cancer Research Group)].

    Masuda N, Toi M, Kuroi K

    Nihon rinsho. Japanese journal of clinical medicine   70 Suppl 7 巻   頁: 763 - 72   2012年9月

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    記述言語:日本語  

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  242. A phase III open-label study to assess safety and efficacy of palonosetron for preventing chemotherapy-induced nausea and vomiting (CINV) in repeated cycles of emetogenic chemotherapy.

    Aogi K, Sakai H, Yoshizawa H, Masuda N, Katakami N, Yanagita Y, Inoue K, Kuranami M, Mizutani M, Masuda N

    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer   20 巻 ( 7 ) 頁: 1507 - 14   2012年7月

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  243. Prognosis of early breast cancer patients treated with sentinel node biopsy: A prospective study from the Japanese society for sentinel node navigation surgery

    Imoto Shigeru, Aikou Takashi, Takei Hiroyuki, Wada Noriaki, Aihara Tomohiko, Inaba Masaaki, Motomura Kazuyoshi, Masuda Norikazu, Nagashima Takeshi, Jinno Hiromitsu, Miura Daishu, Saito Mari, Morita Satoshi, Sakamoto Junichi, Kitajima Masaki

    JOURNAL OF CLINICAL ONCOLOGY   30 巻 ( 15 )   2012年5月

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  244. Prognosis of early breast cancer patients treated with sentinel node biopsy: A prospective study from the Japanese society for sentinel node navigation surgery

    Imoto Shigeru, Aikou Takashi, Takei Hiroyuki, Wada Noriaki, Aihara Tomohiko, Inaba Masaaki, Motomura Kazuyoshi, Masuda Norikazu, Nagashima Takeshi, Jinno Hiromitsu, Miura Daishu, Saito Mari, Morita Satoshi, Sakamoto Junichi, Kitajima Masaki

    JOURNAL OF CLINICAL ONCOLOGY   30 巻 ( 15 )   2012年5月

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    記述言語:日本語  

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  245. [Current status and future perspectives for the treatment of triple-negative breast cancer in Japan].

    Masuda N, Yasojima H, Mizutani M, Yamamura J

    Gan to kagaku ryoho. Cancer & chemotherapy   39 巻 ( 4 ) 頁: 512 - 8   2012年4月

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  246. Neoadjuvant anastrozole versus tamoxifen in patients receiving goserelin for premenopausal breast cancer (STAGE): a double-blind, randomised phase 3 trial.

    Masuda N, Sagara Y, Kinoshita T, Iwata H, Nakamura S, Yanagita Y, Nishimura R, Iwase H, Kamigaki S, Takei H, Noguchi S

    The Lancet. Oncology   13 巻 ( 4 ) 頁: 345 - 52   2012年4月

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  247. [Current status and future perspectives for the treatment of triple-negative breast cancer in Japan].

    Masuda N, Yasojima H, Mizutani M, Yamamura J

    Gan to kagaku ryoho. Cancer & chemotherapy   39 巻 ( 4 ) 頁: 512 - 8   2012年4月

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    記述言語:日本語  

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  248. Randomized phase II study of primary systemic chemotherapy and trastuzumab for operable HER2 positive breast cancer.

    Nakamura S, Ando M, Masuda N, Aogi K, Ino H, Iwata H, Tokuda Y, Yamamoto N, Kasai H, Takeuchi M, Tsuda H, Akiyama F, Kurosumi M, Fujiwara Y

    Clinical breast cancer   12 巻 ( 1 ) 頁: 49 - 56   2012年2月

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  249. Relationship between body mass index and preoperative treatment response to aromatase inhibitor exemestane in postmenopausal patients with primary breast cancer

    Takada M, Saji S, Masuda N, Kuroi K, Sato N, Takei H, Yamamoto Y, Ohno S, Yamashita H, Hisamatsu K, Aogi K, Iwata H, Ueno T, Sasano H, Toi M

    Breast   21 巻 ( 1 ) 頁: 40 - 45   2012年2月

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    記述言語:日本語   出版者・発行元:Breast  

    Background: Some studies have shown that high body mass index (BMI) is associated with inferior outcome after adjuvant therapy with anastrozole in breast cancer patients. We aimed to investigate predictive effect of BMI on clinical response to neoadjuvant therapy with exemestane in postmenopausal patients with primary breast cancer. Patients and methods: The study group consisted of 109 patients from the JFMC 34-0601 neoadjuvant endocrine therapy trial. Patients were categorized into three groups according to BMI: low (BMI<22kg/m2), intermediate (22≤BMI<25kg/m2) and high (BMI≥25kg/m2). Statistical analyses were performed to explore the predictive effect of BMI on clinical response. Results: Higher BMI correlated with positive progesterone receptor status (p<0.01) and low Ki-67 index (p=0.03). Objective response rates (ORR) were 21.7% in low BMI, 56.0% in intermediate BMI and 60.6% in high BMI, respectively (p=0.01). In a multivariate analysis, low BMI was an independent negative predictor of clinical response. Conclusion: Low BMI was associated with a decreased ORR to neoadjuvant endocrine therapy with exemestane. Our results may suggest that the predictive effect of BMI varies according to the type of aromatase inhibitor and objective outcome. © 2011 Elsevier Ltd.

    DOI: 10.1016/j.breast.2011.07.015

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  250. Male breast cancer originating in an accessory mammary gland in the axilla: a case report.

    Yamamura J, Masuda N, Kodama Y, Yasojima H, Mizutani M, Kuriyama K, Mano M, Nakamori S, Sekimoto M

    Case reports in medicine   2012 巻   頁: 286210   2012年

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  251. Objective and longitudinal assessment of dermatitis after postoperative accelerated partial breast irradiation using high-dose-rate interstitial brachytherapy in patients with breast cancer treated with breast conserving therapy: reduction of moisture deterioration by APBI.

    Tanaka E, Yamazaki H, Yoshida K, Takenaka T, Masuda N, Kotsuma T, Yoshioka Y, Inoue T

    International journal of radiation oncology, biology, physics   81 巻 ( 4 ) 頁: 1098 - 104   2011年11月

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  252. First-line bevacizumab in combination with weekly paclitaxel for metastatic breast cancer: efficacy and safety results from a large, open-label, single-arm Japanese study.

    Aogi K, Masuda N, Ohno S, Oda T, Iwata H, Kashiwaba M, Fujiwara Y, Kamigaki S, Ito Y, Ueno T, Takashima S

    Breast cancer research and treatment   129 巻 ( 3 ) 頁: 829 - 38   2011年10月

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  253. Docetaxel followed by fluorouracil/epirubicin/cyclophosphamide as neoadjuvant chemotherapy for patients with primary breast cancer.

    Iwata H, Sato N, Masuda N, Nakamura S, Yamamoto N, Kuroi K, Kurosumi M, Tsuda H, Akiyama F, Ohashi Y, Toi M

    Japanese journal of clinical oncology   41 巻 ( 7 ) 頁: 867 - 75   2011年7月

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  254. Ki67 index changes, pathological response and clinical benefits in primary breast cancer patients treated with 24 weeks of aromatase inhibition

    TOI Masakazu, SAJI Shigehira, MASUDA Norikazu, KUROI Katsumasa, SATO Nobuaki, TAKEI Hiroyuki, YAMAMOTO Yutaka, OHNO Shinji, YAMASHITA Hiroko, HISAMATSU Kazufumi, AOGI Kenjiro, IWATA Hiroji, TAKADA Masahiro, UENO Takayuki, SAJI Shigetoyo, CHANPLAKORN Niramol, SUZUKI Takashi, SASANO Hironobu

    Cancer Sci   102 巻 ( 4 ) 頁: 858 - 865   2011年4月

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  255. Ki67 index changes, pathological response and clinical benefits in primary breast cancer patients treated with 24 weeks of aromatase inhibition

    TOI Masakazu, SAJI Shigehira, MASUDA Norikazu, KUROI Katsumasa, SATO Nobuaki, TAKEI Hiroyuki, YAMAMOTO Yutaka, OHNO Shinji, YAMASHITA Hiroko, HISAMATSU Kazufumi, AOGI Kenjiro, IWATA Hiroji, TAKADA Masahiro, UENO Takayuki, SAJI Shigetoyo, CHANPLAKORN Niramol, SUZUKI Takashi, SASANO Hironobu

    Cancer Sci   102 巻 ( 4 ) 頁: 858 - 865   2011年4月

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  256. Identification of recurrence-related microRNAs in the bone marrow of breast cancer patients.

    Ota D, Mimori K, Yokobori T, Iwatsuki M, Kataoka A, Masuda N, Ishii H, Ohno S, Mori M

    International journal of oncology   38 巻 ( 4 ) 頁: 955 - 62   2011年4月

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    DOI: 10.3892/ijo.2011.926

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  257. Ki67 index changes, pathological response and clinical benefits in primary breast cancer patients treated with 24weeks of aromatase inhibition

    Toi M, Saji S, Masuda N, Kuroi K, Sato N, Takei H, Yamamoto Y, Ohno S, Yamashita H, Hisamatsu K, Aogi K, Iwata H, Takada M, Ueno T, Saji S, Chanplakorn N, Suzuki T, Sasano H

    Cancer Science   102 巻 ( 4 ) 頁: 858 - 865   2011年4月

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    記述言語:日本語   出版者・発行元:Cancer Science  

    Aromatase inhibitor shows efficacy for hormone receptor positive postmenopausal breast cancer. We evaluated the activity of 24weeks of aromatase inhibition with exemestane for primary breast cancer in a neoadjuvant setting. Patients with stageII/IIIA invasive breast cancer with estrogen receptor (ER) and/or progesterone receptor (PgR)-positive status were eligible. Primary endpoints were objective response rate (ORR) and safety. A steroidal aromatase inhibitor exemestane of 25mg/day was administered for 16weeks with an 8-week extension. Secondary endpoints were rates of breast-conserving surgery (BCS), and change of Ki67 index and ER/PgR expression in central laboratory analyses. Between March 2006 and December 2007, 116 patients were enrolled. Among those, 102 patients completed 24weeks of administration. The ORR was 47% (55/116) at Week16 and 51% (59/116) at Week24, respectively. No serious toxicity was seen. ORR was associated with ER Allred scores but not with PgR scores. The significant reduction in Ki67 index was confirmed. No progression was experienced in tumors with less than 15% Ki67 index. Pathological response was observed in 28 (30%) of 94 evaluated cases. No statistical correlation between pre-treatment Ki67 index and pathological response was detected; however, a trend of correlation was found between the post-treatment preoperative endocrine prognostic index (PEPI), a prognostic score and the pathological response. At diagnosis, 59 patients (51%) would have required mastectomy but 40 patients were converted to BCS, showing an increase in the rate of BCS (77%). The 24-week aromatase inhibition provided preferable clinical benefits with significant reduction in Ki67 index. More precise mechanisms of the response need to be investigated. © 2011 Japanese Cancer Association.

    DOI: 10.1111/j.1349-7006.2011.01867.x

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  258. Predictive factors for the effectiveness of neoadjuvant chemotherapy and prognosis in triple-negative breast cancer patients.

    Masuda H, Masuda N, Kodama Y, Ogawa M, Karita M, Yamamura J, Tsukuda K, Doihara H, Miyoshi S, Mano M, Nakamori S, Tsujinaka T

    Cancer chemotherapy and pharmacology   67 巻 ( 4 ) 頁: 911 - 7   2011年4月

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  259. Monthly versus 3-monthly goserelin acetate treatment in pre-menopausal patients with estrogen receptor-positive early breast cancer.

    Masuda N, Iwata H, Rai Y, Anan K, Takeuchi T, Kohno N, Takei H, Yanagita Y, Noguchi S

    Breast cancer research and treatment   126 巻 ( 2 ) 頁: 443 - 51   2011年4月

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  260. Objective assessment of dermatitis following post-operative radiotherapy in patients with breast cancer treated with breast-conserving treatment.

    Yoshida K, Yamazaki H, Takenaka T, Tanaka E, Kotsuma T, Fujita Y, Masuda N, Kuriyama K, Yoshida M, Nishimura T

    Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]   186 巻 ( 11 ) 頁: 621 - 9   2010年11月

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  261. Clinical usefulness of high-dose toremifene in patients relapsed on treatment with an aromatase inhibitor

    YAMAMOTO Yutaka, MASUDA Norikazu, OHTAKE Tohru, YAMASHITA Hiroko, SAJI Shigehira, KIMIJIMA Izo, KASAHARA Yoshio, ISHIKAWA Takashi, SAWAKI Masataka, HOZUMI Yasuo, IWASE Hirotaka

    Breast Cancer   17 巻 ( 4 ) 頁: 254 - 260   2010年10月

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  262. Clinical usefulness of high-dose toremifene in patients relapsed on treatment with an aromatase inhibitor

    YAMAMOTO Yutaka, MASUDA Norikazu, OHTAKE Tohru, YAMASHITA Hiroko, SAJI Shigehira, KIMIJIMA Izo, KASAHARA Yoshio, ISHIKAWA Takashi, SAWAKI Masataka, HOZUMI Yasuo, IWASE Hirotaka

    Breast Cancer   17 巻 ( 4 ) 頁: 254 - 260   2010年10月

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    CiNii Research

  263. PHASE II STUDY OF IRINOTECAN (CPT-11) IN PATIENTS (PTS) WITH PREVIOUSLY TREATED METASTATIC BREAST CANCER (MBC): KMBOG0601

    Hayashi H, Tsurutani J, Satoh T, Sakamoto J, Masuda N, Tokunaga Y, Yamaguchi M, Tominaga S, Fukuoka M, Nakagawa K

    ANNALS OF ONCOLOGY   21 巻   頁: 121 - 121   2010年10月

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  264. PHASE II STUDY OF IRINOTECAN (CPT-11) IN PATIENTS (PTS) WITH PREVIOUSLY TREATED METASTATIC BREAST CANCER (MBC): KMBOG0601

    Hayashi H., Tsurutani J., Satoh T., Sakamoto J., Masuda N., Tokunaga Y., Yamaguchi M., Tominaga S., Fukuoka M., Nakagawa K.

    ANNALS OF ONCOLOGY   21 巻   頁: 121 - 121   2010年10月

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  265. Clinical usefulness of high-dose toremifene in patients relapsed on treatment with an aromatase inhibitor

    Yamamoto Yutaka, Masuda Norikazu, Ohtake Tohru, Yamashita Hiroko, Saji Shigehira, Kimijima Izo, Kasahara Yoshio, Ishikawa Takashi, Sawaki Masataka, Hozumi Yasuo, Iwase Hirotaka

    BREAST CANCER   17 巻 ( 4 ) 頁: 254 - 260   2010年10月

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    記述言語:日本語   出版者・発行元:Breast Cancer  

    Background: Aromatase inhibitors (AIs) have been employed as adjuvant therapy or as treatment for recurrent cases. However, when AI treatment fails, it is unclear which endocrine therapy is the most appropriate to introduce at this point and how effective it will be. In this study, we investigated the efficacy and safety of toremifene (TOR, Fareston®), a selective estrogen receptor modulator (SERM). Methods: Patients with recurrent or advanced breast cancer who had measurable or evaluable lesions, and were diagnosed as having progressive disease during AI treatment and subsequently given TOR at 120 mg/day (TOR120) as endocrine therapy were selected and analyzed retrospectively in relation to their medical history. Results: Of a total of 83 cases examined, 80 were evaluable. The objective response rate (ORR) was 15.0% (12/80), the clinical benefit (CB) rate was 45.0% (36/80), and median time to failure (TTF) was 7.8 months. TOR120 was also effective in the progressive disease cases relapsed on AI treatment. When TOR120 was used, as a first-, second- or third-line treatment, the CB rate was 57% (32/56); this fell to 17% (4/24) when TOR120 was used as a fourth-line or later treatment. There was no response in the five estrogen receptor (ER)-negative cases, compared with an ORR of 15% (10/67) in ER-positive cases. In cases with a human epidermal growth factor receptor 2 (HER2) score of 0, 1+, and 2+, the ORR was 11% (7/61), while there was no response in the five cases with scores of 3+. TOR120 was effective in cases previously treated with tamoxifen (TAM), with an ORR and CB rate of 12 and 29%, respectively. The last AI used was anastrozole in 30 cases and examestane in 46; the response rates to TOR120 were similar in both groups. With regard to adverse effects, hot flushes and/or night sweating was observed in 10 and 12 cases, respectively, but all of them were categorized as grade 1, and the treatment was rated excellent in acceptability. Conclusions: TOR120 was rated excellent in acceptability, and high efficacy was observed when it was used up to third-line treatment for AI-failure cases, although this study may show some selection bias because of the retrospective study. In addition, it was also considered effective for TAM-failure cases. © 2009 The Japanese Breast Cancer Society.

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  266. Randomized study of taxane versus TS-1 in women with metastatic or recurrent breast cancer (SELECT BC).

    Mukai H, Takashima T, Hozumi Y, Watanabe T, Murakami S, Masuda N, Mitsuyama S, Ohmura T, Yajima T, Ohashi Y

    Japanese journal of clinical oncology   40 巻 ( 8 ) 頁: 811 - 4   2010年8月

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  267. Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population.

    Toi M, Iwata H, Yamanaka T, Masuda N, Ohno S, Nakamura S, Nakayama T, Kashiwaba M, Kamigaki S, Kuroi K, Japan Breas, Cancer Research Group-Translational, Research Group

    Cancer   116 巻 ( 13 ) 頁: 3112 - 8   2010年7月

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  268. Effects of toremifene and tamoxifen on lipid profiles in post-menopausal patients with early breast cancer: interim results from a Japanese phase III trial.

    Tominaga T, Kimijima I, Kimura M, Takatsuka Y, Takashima S, Nomura Y, Kasumi F, Yamaguchi A, Masuda N, Noguchi S, Eshima N

    Japanese journal of clinical oncology   40 巻 ( 7 ) 頁: 627 - 33   2010年7月

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    DOI: 10.1093/jjco/hyq021

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  269. Phase III randomized adjuvant study of tamoxifen alone versus sequential tamoxifen and anastrozole in Japanese postmenopausal women with hormone-responsive breast cancer: N-SAS BC03 study.

    Aihara T, Takatsuka Y, Ohsumi S, Aogi K, Hozumi Y, Imoto S, Mukai H, Iwata H, Watanabe T, Shimizu C, Nakagami K, Tamura M, Ito T, Masuda N, Ogino N, Hisamatsu K, Mitsuyama S, Abe H, Tanaka S, Yamaguchi T, Ohashi Y

    Breast cancer research and treatment   121 巻 ( 2 ) 頁: 379 - 87   2010年6月

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  270. Phase I study of combination therapy with weekly paclitaxel and cyclophosphamide for advanced or recurrent breast cancer

    Masuda Norikazu, Nakayama Takahiro, Yamamura Jun, Kamigaki Shunji, Taguchi Tetsuya, Hatta Mai, Sakamoto Junichi

    CANCER CHEMOTHERAPY AND PHARMACOLOGY   66 巻 ( 1 ) 頁: 89 - 94   2010年5月

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    記述言語:日本語   出版者・発行元:Cancer Chemotherapy and Pharmacology  

    Purpose Although anthracycline is a key agent in breast cancer treatment, its use is associated with the risk of cardiotoxicity. Recently, the value of combination therapy with docetaxel and cyclophosphamide was reported. Because the characteristics of paclitaxel differ on weekly versus tri-weekly administration, such as in the induction of apoptosis and anti-angiogenic activity, establishment of a treatment regimen with a combination of paclitaxel and cyclophosphamide (PC) is warranted. We initiated a phase I study to determine the maximum tolerated dose (MTD) and recommended dose (RD) of combination therapy with PC for advanced or recurrent breast cancer. Patients and methods Eligible patients had advanced or recurrent breast cancer. Paclitaxel was given intravenously on days 1, 8, and 15 of every 3-week course, and cyclophosphamide on day 1, over a total of four courses. Paclitaxel was given at 80 mg/m2 for level 1 and 100 mg/m2 for level 2, and cyclophosphamide at 600 mg/m2 in both cases. Onset of dose-limiting toxicity was evaluated during the first course, and tolerability throughout the four courses. Results Four patients were enrolled in each of levels 1 and 2 from October 2006 to November 2007. The main toxicities were grade 3 neutropenia in four patients (50%) and sensory neuropathy in one (12.5%). An MTD was not attained, as neither a hematologic toxicity of grade 4 nor a non-hematologic toxicity of grade 3 or higher was observed during the first course at level 1 or 2. Response rate amongst assessable patients (one in level 1, two in level 2) was 66.7%. Conclusions Safety was well tolerated throughout the four courses at level 2, and this dosage level was therefore regarded as the RD. © Springer-Verlag 2009.

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  271. Oral combination chemotherapy with capecitabine and cyclophosphamide in patients with metastatic breast cancer: a phase II study.

    Tanaka M, Takamatsu Y, Anan K, Ohno S, Nishimura R, Yamamoto Y, Masuda N, Mitsuyama S, Tamura K, Kyushu Breast Cancer Study Group

    Anti-cancer drugs   21 巻 ( 4 ) 頁: 453 - 8   2010年4月

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  272. Predictive factors for anthracycline-based chemotherapy for human breast cancer.

    Miyoshi Y, Kurosumi M, Kurebayashi J, Matsuura N, Takahashi M, Tokunaga E, Egawa C, Masuda N, Kono S, Morimoto K, Kim SJ, Okishiro M, Yanagisawa T, Ueda S, Taguchi T, Tamaki Y, Noguchi S

    Breast cancer (Tokyo, Japan)   17 巻 ( 2 ) 頁: 103 - 9   2010年4月

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  273. Impact of 4-weekly capecitabine plus paclitaxel (XP) combination therapy for metastatic breast cancer: a multicenter phase II trial (KBCSG-0609)

    Yamamoto D, Taguchi T, Masuda N, Nakayama T, Nagata T, Nomura M, Yoshidome K, Yoshino H, Sakamoto J, Noguchi S

    EJC SUPPLEMENTS   8 巻 ( 3 ) 頁: 201 - 201   2010年3月

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  274. Impact of 4-weekly capecitabine plus paclitaxel (XP) combination therapy for metastatic breast cancer: a multicenter phase II trial (KBCSG-0609)

    Yamamoto D., Taguchi T., Masuda N., Nakayama T., Nagata T., Nomura M., Yoshidome K., Yoshino H., Sakamoto J., Noguchi S.

    EJC SUPPLEMENTS   8 巻 ( 3 ) 頁: 201 - 201   2010年3月

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  275. Differential survival following trastuzumab treatment based on quantitative HER2 expression and HER2 homodimers in a clinic-based cohort of patients with metastatic breast cancer.

    Toi M, Sperinde J, Huang W, Saji S, Winslow J, Jin X, Tan Y, Ohno S, Nakamura S, Iwata H, Masuda N, Aogi K, Morita S, Petropoulos C, Bates M

    BMC cancer   10 巻   頁: 56   2010年2月

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  276. Randomized phase III trial of trastuzumab monotherapy followed by trastuzumab plus docetaxel versus trastuzumab plus docetaxel as first-line therapy in patients with HER2-positive metastatic breast cancer: the JO17360 Trial Group.

    Inoue K, Nakagami K, Mizutani M, Hozumi Y, Fujiwara Y, Masuda N, Tsukamoto F, Saito M, Miura S, Eguchi K, Shinkai T, Ando M, Watanabe T, Masuda N, Ohashi Y, Sano M, Noguchi S

    Breast cancer research and treatment   119 巻 ( 1 ) 頁: 127 - 36   2010年1月

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  277. Phase II trial in Japan of sequential administration of weekly paclitaxel followed by FEC as neoadjuvant chemotherapy for locally advanced breast cancer [KBCSG0206 trial: Kinki Breast Cancer Study Group (KBCSG)].

    Taguchi T, Masuda N, Nakayama T, Motomura K, Tsukamoto F, Shimazu K, Nomura T, Morimoto T, Yamamoto H, Wakita K, Nakano Y, Yoneda K, Inaji H, Takatsuka Y, Noguchi S, Kinki Breas, Cancer Study Group, KBCSG

    Oncology   78 巻 ( 5-6 ) 頁: 302 - 8   2010年

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    DOI: 10.1159/000318169

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  278. Study of Low-Dose Capecitabine Monotherapy for Metastatic Breast Cancer

    Taguchi Tetsuya, Nakayama Takahiro, Masuda Norikazu, Yoshidome Katsuhide, Akagi Kenzou, Nishida Yukihiro, Yoshikawa Yukinobu, Ogino Nobuo, Abe Chigusa, Sakamoto Junichi, Noguchi Shinzaburo

    CHEMOTHERAPY   56 巻 ( 2 ) 頁: 166 - 170   2010年

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    記述言語:日本語   出版者・発行元:Chemotherapy  

    Background: Capecitabine is an established therapy for metastatic breast cancer. In Japan, a 4 weekly regimen is often used, but data for this schedule in the first-line setting are lacking. Methods: Metastatic breast cancer patients who had received no chemotherapy for recurrent disease received capecitabine 825 mg/m2 twice daily, on days 1-21 of a 28-day cycle until disease progression or unacceptable toxicity. The primary endpoint was response rate. Results: In 33 eligible patients, median age was 53 years (range 27-73). Prior adjuvant therapy included an anthracycline in 90% and a taxane in 40%. The response rate was 18%; a further 24% had stable disease for ≥6 months. Median progression-free and overall survival were 6.9 and 24.8 months, respectively. The only grade 3 events were neutropenia (6%) and hand-foot syndrome (15%). Conclusions: These preliminary results confirm previous data showing that a lower capecitabine dose is an active and well-tolerated first-line therapy for metastatic breast cancer. Copyright © 2010 S. Karger AG, Basel.

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  279. Longitudinal practical measurement of skin color and moisture during and after breast-conserving therapy: influence of neoadjuvant systemic therapy.

    Yamazaki H, Yoshida K, Kotsuma T, Kuriyama K, Masuda N, Nishimura T, Kobayashi K, Tsubokura T, Nishimura T

    Japanese journal of radiology   27 巻 ( 8 ) 頁: 309 - 15   2009年10月

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  280. Long-term outcome and pattern of relapse after neoadjuvant chemotherapy in patients with human epidermal growth factor receptor 2-positive primary breast cancer.

    Shimizu C, Masuda N, Yoshimura K, Tsuda H, Mano M, Ando M, Tamura K, Fujiwara Y

    Japanese journal of clinical oncology   39 巻 ( 8 ) 頁: 484 - 90   2009年8月

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  281. Prospective assessment of chemotherapy-induced peripheral neuropathy due to weekly paclitaxel in patients with advanced or metastatic breast cancer (CSP-HOR 02 study).

    Kuroi K, Shimozuma K, Ohashi Y, Hisamatsu K, Masuda N, Takeuchi A, Aranishi T, Morita S, Ohsumi S, Hausheer FH

    Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer   17 巻 ( 8 ) 頁: 1071 - 80   2009年8月

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  282. Computed radiography-based mammography with 50-microm pixel size: intra-individual comparison with film-screen mammography for diagnosis of breast cancers.

    Onishi H, Masuda N, Takechi K, Nakayama T, Tatsuta M, Mihara N, Takamura M, Inoue Y, Kuriyama K, Kotsuma Y, Furukawa H, Murakami T, Nakamura H

    Academic radiology   16 巻 ( 7 ) 頁: 836 - 41   2009年7月

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  283. Preoperative u-PAR gene expression in bone marrow indicates the potential power of recurrence in breast cancer cases.

    Mimori K, Kataoka A, Yamaguchi H, Masuda N, Kosaka Y, Ishii H, Ohno S, Mori M

    Annals of surgical oncology   16 巻 ( 7 ) 頁: 2035 - 41   2009年7月

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  284. Phase II study of capecitabine and trastuzumab combination chemotherapy in patients with HER2 overexpressing metastatic breast cancers resistant to both anthracyclines and taxanes.

    Ishida T, Kiba T, Takeda M, Matsuyama K, Teramukai S, Ishiwata R, Masuda N, Takatsuka Y, Noguchi S, Ishioka C, Fukushima M, Ohuchi N

    Cancer chemotherapy and pharmacology   64 巻 ( 2 ) 頁: 361 - 9   2009年7月

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  285. Molecular detection of lymph node metastases in breast cancer patients: results of a multicenter trial using the one-step nucleic acid amplification assay.

    Tamaki Y, Akiyama F, Iwase T, Kaneko T, Tsuda H, Sato K, Ueda S, Mano M, Masuda N, Takeda M, Tsujimoto M, Yoshidome K, Inaji H, Nakajima H, Komoike Y, Kataoka TR, Nakamura S, Suzuki K, Tsugawa K, Wakasa K, Okino T, Kato Y, Noguchi S, Matsuura N

    Clinical cancer research : an official journal of the American Association for Cancer Research   15 巻 ( 8 ) 頁: 2879 - 84   2009年4月

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  286. [Examination about the influence for daily life that nail and skin disorders induced by docetaxel in patients with breast cancer].

    Kohama K, Masuda N, Yamamura J, Ishitobi M, Masuda H, Ogawa M, Todaka K, Tanaka T, Ueno H, Nakamori S, Tsujinaka T

    Gan to kagaku ryoho. Cancer & chemotherapy   36 巻 ( 4 ) 頁: 615 - 8   2009年4月

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  287. [Examination about the influence for daily life that nail and skin disorders induced by docetaxel in patients with breast cancer].

    Kohama K, Masuda N, Yamamura J, Ishitobi M, Masuda H, Ogawa M, Todaka K, Tanaka T, Ueno H, Nakamori S, Tsujinaka T

    Gan to kagaku ryoho. Cancer & chemotherapy   36 巻 ( 4 ) 頁: 615 - 8   2009年4月

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    PubMed

  288. Evaluation of suspicious nipple discharge by magnetic resonance mammography based on breast imaging reporting and data system magnetic resonance imaging descriptors.

    Tokuda Y, Kuriyama K, Nakamoto A, Choi S, Yutani K, Kunitomi Y, Haneda T, Kawai M, Masuda N, Takeda M, Nakamura H

    Journal of computer assisted tomography   33 巻 ( 1 ) 頁: 58 - 62   2009年1月

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  289. A phase II study of palonosetron combined with dexamethasone to prevent nausea and vomiting induced by highly emetogenic chemotherapy

    Maemondo M, Masuda N, Sekine I, Kubota K, Segawa Y, Shibuya M, Imamura F, Katakami N, Hida T, Takeo S, Isobe H, Kikuchi Y, Ando M, Yokoyama A, Miyao H, Fujii H, Sakai H, Yoshimori K, Genma A, Takeda Y, Masahiro T, Arai H, Ogura T, Koizumi W, Eguchi K, Kitagawa C, Sawa T, Atagi S, Ogawara M, Nishimura T, Negoro S, Kiura K, Shigeoka Y, Ichinose Y, Senba H

    Annals of Oncology   20 巻 ( 11 ) 頁: 1860 - 1866   2009年

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    記述言語:日本語   出版者・発行元:Annals of Oncology  

    Background: This is a randomized, double-blind, dose-ranging study in patients receiving highly emetogenic chemotherapy (HEC) to evaluate the safety, efficacy, and pharmacokinetics of palonosetron, in combination with dexamethasone. Materials and methods: We randomized 233 patients to receive palonosetron as a single i.v. bolus dose of 0.075, 0.25, or 0.75 mg before administration of HEC. Dexamethasone (12-16 mg i.v. on day 1, 8 mg i.v. on day 2, and 4-8 mg i.v. on day 3) was administered for prophylactic antiemesis. Pharmacokinetics of palonosetron was analyzed in 24 patients. Results: In this study, all patients were given ≥50 mg/m2 cisplatin, which was considered to be HEC. No significant differences in complete response (CR: no emesis and no rescue medication) rates were found in the first 24 h between the 0.075-, 0.25-, and 0.75-mg groups (77.6%, 81.8%, and 79.5%, respectively). In the 120-h period of overall observation, CR rates increased in a dose-dependent manner. In the 0.75-mg group, we observed a significantly longer time to treatment failure than in the 0.075-mg group (median time >120 versus 82.0 h, P = 0.038). Palonosetron was tolerated well and did not show any dose-related increase in adverse effects. Conclusions: Palonosetron at doses of 0.25 and 0.75 mg was shown to be effective in preventing chemotherapy-induced nausea and vomiting with high CR rates of patients treated with HEC in Japan. All tested doses of palonosetron were tolerated well. © The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

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  290. Phase I study of combination therapy with weekly paclitaxel and cyclophosphatamide for advanced or recurrent breast cancer

    Nakayama T., Masuda N., Yamamura J., Kamigaki S., Taguchi T., Hatta M., Sakamoto J.

    BREAST CANCER RESEARCH   11 巻   頁: S15 - S15   2009年

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  291. Phase II study of preoperative sequential FEC and docetaxel predicts of pathological response and disease free survival

    Toi M, Nakamura S, Kuroi K, Iwata H, Ohno S, Masuda N, Kusama M, Yamazaki K, Hisamatsu K, Sato Y, Kashiwaba M, Kaise H, Kurosumi M, Tsuda H, Akiyama F, Ohashi Y, Takatsuka Y

    Breast Cancer Research and Treatment   110 巻 ( 3 ) 頁: 531 - 539   2008年8月

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    記述言語:日本語   出版者・発行元:Breast Cancer Research and Treatment  

    Purpose: This multicenter phase II study examined the impact of pathological effect on survival after preoperative chemotherapy in Japanese women with early stage breast cancer. Patients and methods: Prior to surgery, patients received four cycles of FEC (fluorouracil 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2 q3w) followed by four cycles of docetaxel (75 mg/m2 q3w). Primary endpoint was 3 year disease free survival (DFS) stratified by the absence or presence of Quasi-pCR (QpCR; absence of invasive tumor or only focal residual tumor cells). Secondary endpoints were predictors for QpCR, clinical response, breast conservation rate, and safety. Results: Between June 2002 and June 2004, 202 women were enrolled. Among 191 assessable patients, 25% achieved QpCR. With 40 months median follow-up, 3 year DFS was estimated at 91% for all patients. 3 year DFS for patients with QpCR was 98% vs. 89% without QpCR (hazard ratio 0.38 [95% Confidence Interval 0.09-0.84], P = 0.0134). HER2 status and response to FEC were independent predictors of QpCR. The overall clinical response was 75%; 85% of patients achieved breast conservation. Grade 3/4 neutropenia was the most common adverse event, observed in 44% and 35% of patients during FEC and docetaxel, respectively. Treatment related side effects were manageable; there were no treatment related fatalities. Conclusion: FEC followed by docetaxel is an active and manageable preoperative regimen for women with early stage breast cancer. QpCR following preoperative chemotherapy predicts favorable DFS. HER2 overexpression and clinical response to FEC predict QpCR. © 2007 Springer Science+Business Media, LLC.

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  292. Capecitabine and paclitaxel combination chemotherapy for inoperable or recurrent breast cancer: A phase I dose-finding study by the Kinki Breast Cancer Study Group

    Masuda N, Taguchi T, Nakayama T, Shiba E, Watatani M, Kurebayashi J, Takatsuka Y, Sakamoto J, Noguchi S

    Cancer Chemotherapy and Pharmacology   61 巻 ( 6 ) 頁: 989 - 995   2008年5月

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    記述言語:日本語   出版者・発行元:Cancer Chemotherapy and Pharmacology  

    Background: The combination of capecitabine and paclitaxel (XP) has demonstrated synergistic antitumor activity in preclinical models. Three-weekly XP regimens have demonstrated excellent efficacy in phase II and III trials in metastatic breast cancer. We conducted a dose-finding study to identify the recommended 4-weekly XP regimen in patients with inoperable or recurrent breast cancer for phase II evaluation. Methods: Eligible patients had inoperable or recurrent breast cancer previously treated with chemotherapy (but not capecitabine or paclitaxel) in the (neo)adjuvant or metastatic setting. Each 4-week treatment cycle consisted of escalating doses of capecitabine (628 or 829 mg/m2 twice daily [b.i.d.] on days 1-21) and paclitaxel (80 or 90 mg/m2 on days 1, 8, and 15). Dose-limiting toxicities (DLT) were evaluated during the first two cycles. Results: Nine patients were treated. At dose level 1 (capecitabine 628 mg/m2 b.i.d. plus paclitaxel 80 mg/m2), one patient experienced a DLT (grade 3 non-hematologic toxicity). There were no further DLTs at dose level 1 or 2. Although the MTD was not reached, dose level 2 (capecitabine 829 mg/m2 b.i.d., days 1-21, plus paclitaxel 80 mg/m2, days 1, 8, and 15, every 28 days) is recommended for phase II evaluation, taking into consideration the single-agent doses used in Japan and the doses identified in Western studies of 3-weekly XP. The overall response rate was 44%; all patients treated at dose level 2 achieved a partial response. Conclusions: This 4-weekly XP regimen was well tolerated, active in patients with pretreated advanced breast cancer, and could be given as outpatient treatment. These results are consistent with findings of phase II and III trials evaluating 3-weekly regimens, and indicate that further investigation of a 4-weekly XP regimen is warranted. © 2007 Springer-Verlag.

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  293. Clinical usefulness of high-dose toremifene for patients failed by treatment with aromatase inhibitor

    Iwase H, Yamamoto Y, Ohtake T, Masuda N, Yamashita H, Saji S, Kimijime I, Kasahara Y, Ishikawa T, Sawaki M

    EJC SUPPLEMENTS   6 巻 ( 7 ) 頁: 179 - 179   2008年4月

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  294. Clinical usefulness of high-dose toremifene for patients failed by treatment with aromatase inhibitor

    Iwase H., Yamamoto Y., Ohtake T., Masuda N., Yamashita H., Saji S., Kimijime I., Kasahara Y., Ishikawa T., Sawaki M.

    EJC SUPPLEMENTS   6 巻 ( 7 ) 頁: 179 - 179   2008年4月

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  295. Comparison of ticlopidine and cilostazol for the prevention of restenosis after percutaneous transluminal coronary angioplasty

    Nagaoka N., Matsubara T., Okazaki K., Masuda N., Shikaura K., Hotta N.

    Japanese Heart Journal   42 巻 ( 1 ) 頁: 43 - 54   2001年4月

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    記述言語:日本語   出版者・発行元:Japanese Heart Journal  

    Prevention of restenosis after percutaneous transluminal coronary angioplasty (PTCA) continues to be a significant problem. Recent controlled studies have demonstrated that cilostazol suppresses restenosis after PTCA. The effects of ticlopidine, another antiplatelet agent, were compared in terms of outcomes of patients randomized for treatment with the two drugs after PTCA. A total of 35 patients (47 lesions) were assigned prospectively and randomly to ticlopidine (17 patients, 24 lesions) and cilostazol (18 patients, 23 lesions) groups. Minimal luminal diameter (MLD) and percentage of stenosis to reference diameter were estimated before PTCA, just after the procedure and after 4 months follow-up. All patients underwent 4 months angiographic follow-up, at the end of which MLD was 2.03 ± 0.71 mm in the ticlopidine group and 2.05 ± 0.68 mm in the cilostazol group (p = 0.95), and the percentage of stenosis to reference diameter was 31.4 ± 16.7% and 30.0 ± 17.0%, respectively (p = 0.78). The restenosis rate was 12.5% in the ticlopidine group and 17.4% in the cilostazol group (p = 0.69), relatively low as compared to the 20% to 30% reported in previous studies. Adverse drug reactions during the follow-up period were observed in two of the ticlopidine group and none of the cilostazol group. We conclude that both ticlopidine and cilostazol are effective for the prevention of restenosis after PTCA, however the former may be associated with slight side effects.

    DOI: 10.1536/jhj.42.43

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  296. Comparison of ticlopidine and cilostazol for the prevention of restenosis after percutaneous transluminal coronary angioplasty

    Nagaoka N, Matsubara T, Okazaki K, Masuda N, Shikaura K, Hotta N

    JAPANESE HEART JOURNAL   42 巻 ( 1 ) 頁: 43 - 54   2001年1月

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  297. Comparison of ticlopidine and cilostazol for the prevention of restenosis after percutaneous transluminal coronary angioplasty

    Nagaoka N, Matsubara T, Okazaki K, Masuda N, Shikaura K, Hotta N

    JAPANESE HEART JOURNAL   42 巻 ( 1 ) 頁: 43 - 54   2001年1月

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    記述言語:日本語  

    Web of Science

  298. Single cell analysis of CAG repeat in brains of dentatorubral-pallidoluysian atrophy (DRPLA)

    Hashida H, Goto J, Suzuki T, Jeong S.Y, Masuda N, Ooie T, Tachiiri Y, Tsuchiya H, Kanazawa I

    Journal of the Neurological Sciences   190 巻 ( 1-2 ) 頁: 87 - 93   2001年

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    出版者・発行元:Journal of the Neurological Sciences  

    Somatic mosaicism of an expanded repeat is present in tissues of patients with triplet repeat diseases. Of the spinocerebellar ataxias associated with triplet repeat expansion, the most prominent heterogeneity of the expanded repeat is seen in dentatorubral-pallidoluysian atrophy (DRPLA). The common feature of this somatic mosaicism is the difference in the repeat numbers found in the cerebellum as compared to other tissues. The expanded allele in the cerebellum shows a smaller degree of expansion. We previously showed by microdissection analysis that the expanded allele in the granular layer in DRPLA cerebellum has less expansion than expanded alleles in the molecular layer and white matter. Whether this feature of lesser expansion in granule cells is common to other types of neurons is yet to be clarified. We used a newly developed excimer laser microdissection system to analyze somatic mosaicism in the brains of two patients, one with early- and another with late-onset DRPLA, and used single cell PCR to observe the cell-to-cell differences in repeat numbers. In the late onset patient, repeat expansion was more prominent in Purkinje cells than in granule cells, but less than that in the glial cells. In the early onset patient, repeat expansion in Purkinje cells was greater than in granule cells but did not differ from that in glial cells. These findings suggest that there is a difference in repeat expansion among neuronal subgroups and that the number of cell division cycles is not the only determinant of somatic mosaicism. © 2001 Published by Elsevier Science B.V.

    DOI: 10.1016/S0022-510X(01)00596-2

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    佐治 重衡, 増田 慎三, 戸井 雅和

    文光堂  2023年  ( ISBN:9784830622649

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  2. 乳癌薬物療法の要点と盲点

    佐治 重衡, 増田 慎三, 戸井 雅和

    文光堂  2023年  ( ISBN:9784830622649

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    記述言語:日本語

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  3. 治療戦略に役立つ : 臨床医・病理医のための乳腺病理の見かた・考え方

    増田 慎三, 堀井 理絵

    メジカルビュー社  2022年  ( ISBN:9784758318174

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    記述言語:日本語

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  4. 治療戦略に役立つ臨床医・病理医のための乳腺病理の見かた・考え方

    増田 慎三, 堀井 理絵

    メジカルビュー社  2022年  ( ISBN:9784758318174

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    記述言語:日本語

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  5. 治療戦略に役立つ : 臨床医・病理医のための乳腺病理の見かた・考え方

    増田 慎三, 堀井 理絵

    メジカルビュー社  2022年  ( ISBN:9784758318174

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    記述言語:日本語

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  6. 治療戦略に役立つ臨床医・病理医のための乳腺病理の見かた・考え方

    増田 慎三, 堀井 理絵

    メジカルビュー社  2022年  ( ISBN:9784758318174

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    記述言語:日本語

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  7. 乳がん薬物療法副作用マネジメント

    増田 慎三

    メジカルビュー社  2021年  ( ISBN:9784758318143

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  8. 乳がん薬物療法副作用マネジメント

    増田 慎三

    メジカルビュー社  2021年  ( ISBN:9784758318143

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    記述言語:日本語

    CiNii Books

  9. 乳がん薬物療法副作用マネジメント : プロのコツ

    増田 慎三

    メジカルビュー社  2017年  ( ISBN:9784758318006

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  10. 乳がん薬物療法副作用マネジメント : プロのコツ

    増田 慎三

    メジカルビュー社  2017年  ( ISBN:9784758318006

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    記述言語:日本語

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  11. Engineered cell manipulation for biomedical application

    明石 満, 赤木 隆美, 松崎 典弥, Zucolotto V

    Springer  2014年  ( ISBN:9784431551386

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    記述言語:英語

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  12. The periplasm

    Ehrmann Michael, American Society for Microbiology

    ASM Press  2007年  ( ISBN:1555813984

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    記述言語:英語

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  13. The periplasm

    Ehrmann Michael, American Society for Microbiology

    ASM Press  2007年  ( ISBN:1555813984

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    記述言語:英語

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