Phase II clinical study of eribulin monotherapy in Japanese patients with metastatic breast cancer who had well-defined taxane resistance

• DOI: 10.1007/s10549-016-3808-x
• Publication Date: 2016-04-28T17:21:46Z
• Authors: Kenichi Inoue; Tsuyoshi Saito; Katsuhiko Okubo; Kei Kimizuka; Hirofumi Yamada; Takashi Sakurai; Kazuo Ishizuna; Satoshi Hata; Toshihiro Kai; Masafumi Kurosumi
• Keywords: Eribulin; Taxane; Tolerability; Clinical endpoint

No clinical evidence on the efficacy and safety of eribulin monotherapy has been obtained by a prospective study in patients with metastatic breast cancer (MBC) who had well-defined taxane resistance. The present Phase II, multicenter, single-arm, open-label aimed to obtain evidence. Japanese female patients, aged 33–74 years metastasis taxane-resistant histopathologically confirmed cancer, received mesylate 1.4 mg/m2 (equivalent 1.23 [expressed as free base]) 2- 5-min intravenous infusion days 1 8 each 21-day cycle. primary endpoint was benefit rate (CBR) [complete response (CR), partial (PR), long-term stable disease (LSD) ≥24 weeks]. A total 51 underwent chemotherapy cycles (median 4; range 1–42 cycles). CBR 39.2 % (CR 2.0 %; PR 23.5 LSD 13.7 %), progressive 49.0 %. median progression-free survival overall were 3.6 months [95 confidence interval (CI) 2.6–4.6 months] 11.7 (95 CI 9.2–14.2 months), respectively. Grade 3 or greater adverse events leukopenia (23.5 neutropenia (35.3 anemia (5.9 febrile (7.8 %). incidences grade 4 peripheral sensory neuropathy 0 %, Eribulin showed clinically manageable tolerability profile dose adjustments symptomatic treatment. effective well tolerated heavily pretreated MBC resistance, thus providing potential therapeutic option settings.