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Poster display session

1449 - Factors associated with prolonged time to treatment failure with fulvestrant 500 mg in patients with postmenopausal estrogen receptor-positive advanced/metastatic breast cancer (JBCRG-C06; Safari): A subgroup analysis


11 Sep 2017


Poster display session


Cytotoxic Therapy;  Breast Cancer


Hidetoshi Kawaguchi


Annals of Oncology (2017) 28 (suppl_5): v74-v108. 10.1093/annonc/mdx365


H. Kawaguchi1, K. Aogi2, N. Masuda3, T. Nakayama4, Y. Ito5, S. Ohtani6, N. Sato7, T. Takano8, S. Saji9, E. Tokunaga10, Y. Hasegawa11, M. Hattori12, T. Fujisawa13, S. Morita14, H. Yamashita15, T. Yamashita16, Y. Yamamoto17, D. Yotsumoto18, M. Toi19, S. Ohno20

Author affiliations

  • 1 Department Of Breast Surgery, Matsuyama Red Cross Hospital, 790-8524 - Matsuyama/JP
  • 2 Division Of Breast Surgery, Shikoku Cancer Center, 791-0280 - Matsuyama/JP
  • 3 Department Of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, 540-0006 - Osaka/JP
  • 4 Department Of Breast And Endocrine Surgery, Osaka International Cancer Institute, 537-0025 - Osaka/JP
  • 5 Breast Medical Oncology Department, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 6 Department Of Breast Surgery, Hiroshima City Hospital, 730-0011 - Hiroshima/JP
  • 7 Department Of Breast Oncology, Niigata Cancer Center Hospital, 951-8566 - Niigata/JP
  • 8 Department Of Medical Oncology, Toranomon Hospital, 105-8470 - Tokyo/JP
  • 9 Department Of Medical Oncology, Fukushima Medical University, 960-1295 - Fukushima/JP
  • 10 Department Of Breast Oncology, Kyushu Cancer Center, 811-1395 - Fukuoka/JP
  • 11 Department Of Breast Surgery, Hirosaki Municipal Hospital, 036-8187 - Hirosaki/JP
  • 12 Breast Oncology, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 13 Department Of Breast Oncology, Gunma Prefectural Cancer Center, 373-8550 - Gunma/JP
  • 14 Biomedical Statistics And Bioinformatics, Graduate School of Medicine, Kyoto University, 606-8507 - Kyoto/JP
  • 15 Breast Surgery, Hokkaido University Graduate School of Medicine, 0600808 - Sapporo/JP
  • 16 Department Of Breast And Endocrine Surgery, Kanagawa Cancer Center, 241-8515 - Yokohama/JP
  • 17 Department Of Breast And Endocrine Surgery, Kumamoto University, Graduate School of Medical Sciencies, 860-8556 - Kumamoto/JP
  • 18 Department Of Breast Surgical Oncology, Hakuaikai Medical Corporation, Sagara Hospital, 892-0833 - Kagoshima/JP
  • 19 Department Of Breast Surgery, Kyoto University-Graduate school of medicine, 606-8507 - Kyoto/JP
  • 20 Breast Oncology Center, The Cancer Institute Hospital Of JFCR, 135-8550 - Tokyo/JP


Abstract 1449


This subanalysis of a retrospective, multicenter, cohort study of fulvestrant 500 mg (F500) in advanced/metastatic breast cancer (AMBC) patients in Japan (UMIN000015168) sought to identify clinical factors associated with prolonged time to treatment failure (TTF).


We analyzed ER+/human epidermal growth factor receptor 2 (HER2)-negative and ER+/HER2-positive patients who received F500 as 2nd- or later-line treatment. Factors investigated were age (≥65/≤65 years), treatment line (≥4th/3rd/2nd), time from AMBC diagnosis to F500 use (


We registered 1072 patients who received F500 between November 2011 and December 2014 at 16 sites in Japan. In the ER+/HER2− group (n = 828), median TTF was 5.4 months. By univariate analysis, higher age, earlier F500 use and no prior chemotherapy were associated with significantly longer TTF. By multivariate analysis, higher age, longer time from AMBC diagnosis to F500 use, no prior palliative chemotherapy and F500 treatment line were correlated with prolonged TTF (Table). In the ER+/HER2+ group (n = 132), treatment line was correlated with TTF (median 4.6 months) in the univariate analysis (P = 0.042); no factors significantly correlated with TTF in the multivariate analysis.Table:

302P Factors correlated with TTF in ER+/HER2− AMBC patients

ER+/HER2−Hazard ratio95% confidence intervalP
Age (≥65/


In ER+/HER2− patients who received F500 as a ≥ 2nd-line treatment, treatment line, advanced age, no prior palliative chemotherapy and a longer time from AMBC diagnosis to F500 use were associated with longer TTF.

Clinical trial identification


Legal entity responsible for the study

Japan Breast Cancer Research Group (JBCRG)


Japan Breast Cancer Research Group (JBCRG) and AstraZeneca


H. Kawaguchi: Leadership Position/Advisory Role: Chugai, AstraZeneca. Consulting fee/honorarium: Chugai, AstraZeneca, Eisai, Kyowa Kirin, Novartis, Taiho. K. Aogi: Personal fees as honoraria: Chugai, Eisai, Sanofi, SRL, AstraZeneca, Taiho, Novartis, Daiichi Sankyo, Mochida, Ono, Otsuka, and Eli Lilly Japan, and the institution received research funds from Chugai, Eisai and Sanofi. N. Masuda: Personal fees as honoraria: Chugai Pharmaceutical and AstraZeneca, and the institution received research funds from Chugai Pharmaceutical and Eisai. T. Nakayama: Lecture\'s Fee: AstraZeneca, Chugai Pharmaceutical Co., Ltd. Novartis Pharma K.K. Y. Ito: Research Funds: MSD, AstraZeneca, Novartis, Parexel, Chugai, Lilly. T. Takano: Research Funds: Chugai, Takeda, Novartis. S. Saji: Honoraria from AstraZeneca, Chugai Pharmaceutical, Eisai, Novartis Pharma, and research funds from AstraZeneca and Chugai Pharmaceutical. S. Morita: Lecture\'s Fee and Consulting fee/honorarium: AstraZeneca. H. Yamashita: Research Funds: Taiho Pharmaceutical, Daiichi Sankyo, Chugai Pharmaceutical, Takeda Pharmaceutical. T. Yamashita: Consulting fee/honorarium: Chugai, Eisai, Novartis Pharma, Taiho, Nippon Kayaku, AstraZeneca, Takeda, Kyowa Kirin, Pfizer. Y. Yamamoto: Consulting fee/honorarium: Chugai, AstraZeneca, Novartis, Esai, KyowaHakko-Kirin, Taiho, Nipponkayaku, Takeda. S. Ohno: Consulting fee/honorarium: Chugai, AstraZeneca, Eisai, Novartis. All other authors have declared no conflicts of interest.

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