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Poster lunch

1483 - Phase II trial of Eribulin and S-1 combination therapy for advanced or recurrent breast cancer (97P)


18 Nov 2017


Poster lunch


Cytotoxic Therapy;  Breast Cancer


Tsutomu Iwasa


Annals of Oncology (2017) 28 (suppl_10): x26-x34. 10.1093/annonc/mdx654


T. Iwasa1, J. Tsurutani1, Y. Mizuno2, Y. Kojima3, T. Takashima4, N. Matsunami5, T. Morimoto6, J. Yamamura7, S. Ohtani8, Y. Tanabe9, S. Watanabe1, R. Kato1, H. Tanino10, S. Tokunaga11, H. Abe12, S.T. Tsuyuki13, F. Hara14, T. Takano9, Y. Komoike15, K. Nakagawa16

Author affiliations

  • 1 Medical Oncology, Kindai University Fuculty of Medicine, 5898511 - Osaka-Sayama/JP
  • 2 Breast Surgery, Yokkaichi Municipal Hospital, 510-8567 - Yokkaichi/JP
  • 3 Breast And Endocrine Surgery, St. Marianna University School of Medicine, Kawasaki/JP
  • 4 Surgical Oncology, Osaka City University Medical School, 545-8585 - Osaka/JP
  • 5 Breast Surgery, Osaka Rosai Hospital, Osaka/JP
  • 6 Breast Surgery, Yao Municipal Hospital, Yao/JP
  • 7 Department Of Surgery, Sakai City Medical Center, 5938304 - Sakai/JP
  • 8 Department Of Breast Surgery, Hiroshima City Hiroshima Citizens Hospital, Hiroshima/JP
  • 9 Medical Oncology, Toranomon Hospital, 105-8470 - Tokyo/JP
  • 10 Breast Surgery, Kobe University Hospital, Kobe/JP
  • 11 Medical Oncology, Osaka City General Hospital, Osaka City/JP
  • 12 Breast Center, Bell Land General Hospital, Sakai/JP
  • 13 Breast Surgery, Osaka Red Cross Hospital, Osaka/JP
  • 14 Department Of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama/JP
  • 15 Breast And Endocrine Surgery, Kindai University Fuculty of Medicine, 5898511 - Osaka-Sayama/JP
  • 16 Medical Oncology, Kindai University, 5898511 - Osaka-Sayama/JP


Abstract 1483


Eribulin is a non-taxane microtubule dynamics inhibitor that has been proven to prolong overall survival in patients with breast cancer. S-1, an oral anticancer drug, has demonstrated non-inferiority in overall survival (OS) to taxane as first-line chemotherapy for metastatic breast cancer (MBC). We previouly reported phase I trial results for the combination of these drugs with an overall response rate of 41.7% and median progression free survival (PFS) of 7.6 months. George W et.al (J Clin Oncol 2003) suggested that estrogen receptor negativity, the presence of three or more sites of disease, a short disease-free interval (1 to 24 months), and prior systemic therapy all predicted for impaired overall survival in their multivariate analysis. Considering these factors, we conducted a multicenter phase II study of this combination to further evaluate its safety and efficacy.


Recurrent or advanced breast cancer patients previously treated with anthracycline or taxanes were enrolled from September 2014 to May 2016. Patients received Eribulin 1.4 mg/m2 day1 and day8 intravenously and S-1 50 mg/m2 from day1 to day14 orally. Primary objective was to investigate safety and efficacy. Secondary objectives were to evaluate PFS, OS and clinical benefit rate (CBR) using Response Criteria in Solid Tumors (RECIST).


Thirty-two patients were enrolled this trial and 30 patients were evaluable. Objective response rate was 36.7%. There were 3 [10%] complete responses, 8 [26.7%] partial responses and 11 [36.7%] stable diseases. This combination therapy had a manageable safety profiles consistent with the known adverse effects of both drugs. The most common grade3-4 adverse events were neutropenia (22 [73.3%] of 32 patients), leukopenia (13 [43.3%] of 32 patients), febrile neutropenia (3 [9.4%] of 32 patients) and peripheral neuropathy (4 [12.5%] of 32 patients). CBR was 46.7%. The median overall survival and the median PFS was not reached.


We showed tolerability and clinical activity in this combination therapy in a subset of patients with poor prognosis. Eribulin in combination with S-1 may represent a promising treatment option for advanced or recurrent breast cancer patients.

Clinical trial identification

Legal entity responsible for the study





All authors have declared no conflicts of interest.

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