BMC Cancer (Oct 2019)

Multicentre, phase II study of eribulin in combination with S-1 in patients with advanced breast cancer

  • Tsutomu Iwasa,
  • Junji Tsurutani,
  • Satomi Watanabe,
  • Ryoji Kato,
  • Yutaka Mizuno,
  • Yasuyuki Kojima,
  • Tsutomu Takashima,
  • Nobuki Matsunami,
  • Takashi Morimoto,
  • Jun Yamamura,
  • Shoichiro Ohtani,
  • Yuko Tanabe,
  • Tetsuhiro Yoshinami,
  • Toshimi Takano,
  • Yoshifumi Komoike,
  • Kazuhiko Nakagawa

DOI
https://doi.org/10.1186/s12885-019-6200-5
Journal volume & issue
Vol. 19, no. 1
pp. 1 – 8

Abstract

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Abstract Background We previously reported the synergistic effect of S-1 and eribulin in preclinical models. In addition, our phase I study revealed the recommended dose for the phase II study of the combination therapy in advanced breast cancer (ABC) patients pre-treated with anthracycline and taxane. Our current study reports on the efficacy and safety of the combined use of eribulin and S-1 in patients with ABC and poor prognosis. Methods Patients with breast cancer who received prior anthracycline- and/or taxane-based therapy were assigned to receive a combination therapy of eribulin (1.4 mg/m2 on days 1 and 8, every 21 days) and S-1 (65 mg/m2, on days 1 to 14, every 21 days) for advanced/metastatic disease. All patients had at least one clinicopathological factor such as being oestrogen receptor negative, Human Epidermal Growth Factor Receptor 2 (HER2) receptor negative, presence of visceral involvement, presence of three or more metastatic sites, or having a disease-free interval shorter than 2 years. The primary endpoint was the independent-reviewer assessed objective response rate (ORR). Secondary endpoints were clinical benefit rate, disease control rate, progression-free survival (PFS), and overall survival (OS). Results This study enrolled 33 patients. Confirmed ORR was 33.3% (95% CI: 17.3 to 52.8). Median PFS was 7.5 months (95% CI: 4.0 to 14.3). Median OS time was not reached during the current experimental periods. The most common grade 3/4 adverse event was neutropenia (68.8%). Conclusions The combination of eribulin and S-1 is safe and effective for treatment in patients with ABC and poor prognosis. Trial registration Current Controlled Trials UMIN000015049, date of registration: September 5th 2014.

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