Watanabe Junichiro
Breast Oncology, Shizuoka Cancer Center Hospital, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777 Japan.
Springerplus. 2015 Oct 19;4:625. doi: 10.1186/s40064-015-1422-8. eCollection 2015.
Despite being routinely prescribed worldwide for several years, data regarding the safety, efficacy, and survival benefit of eribulin in clinical settings for the treatment of metastatic breast cancer (MBC) are limited. This retrospective observational study investigated the survival benefit of eribulin compared with conventional chemotherapy regimens in Japanese women with MBC. Women with estrogen receptor (ER)-positive human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) MBC, including unresectable locally advanced breast cancer, treated at a single institution were included in this study. The primary efficacy measure assessed overall survival (OS), and safety was evaluated as the number of grade 3 and 4 adverse events. Of the 293 patients analyzed, 66 received eribulin (eribulin arm) and 227 received conventional chemotherapeutic agents excluding eribulin (noneribulin arm). The median OS from MBC diagnosis in the eribulin arm was 72.1 months (95 % CI 13.3-168.3) compared with 43.3 months (95 % CI 9.1-202.0) in the noneribulin arm [hazard ratio (HR): 0.67, 95 % CI 0.47-0.96; P = 0.025]. No significant differences were noted in OS between eribulin used as a first-/second-line or third-/>third-line treatment for MBC. No patient discontinued eribulin therapy due to AEs. In the eribulin arm, grade 4 neutropenia and grade 3 febrile neutropenia were observed in 8 (12.1 %) and 4 (6.1 %) patients, respectively. Eribulin therapy has a survival benefit in Japanese women with ER+/HER2- MBC in routine clinical practice, with no unexpected grade 3/4 AEs. Interestingly, eribulin might be beneficial as any line therapy for ER+/HER2- MBC.
尽管在全球范围内多年来一直被常规处方使用,但关于艾日布林在转移性乳腺癌(MBC)临床治疗中的安全性、疗效和生存获益的数据仍然有限。这项回顾性观察性研究调查了艾日布林与传统化疗方案相比,在日本MBC女性患者中的生存获益情况。本研究纳入了在单一机构接受治疗的雌激素受体(ER)阳性、人表皮生长因子受体2(HER2)阴性(ER+/HER2-)的MBC女性患者,包括不可切除的局部晚期乳腺癌患者。主要疗效指标评估总生存期(OS),安全性评估为3级和4级不良事件的数量。在分析的293例患者中,66例接受艾日布林治疗(艾日布林组),227例接受不包括艾日布林的传统化疗药物治疗(非艾日布林组)。艾日布林组从MBC诊断开始的中位OS为72.1个月(95%CI 13.3 - 168.3),而非艾日布林组为43.3个月(95%CI 9.1 - 202.0)[风险比(HR):0.67,95%CI 0.47 - 0.96;P = 0.025]。在将艾日布林用作MBC的一线/二线或三线/三线以上治疗时,OS未观察到显著差异。没有患者因不良事件而停止艾日布林治疗。在艾日布林组中,分别有8例(12.1%)和4例(6.1%)患者出现4级中性粒细胞减少和3级发热性中性粒细胞减少。在常规临床实践中,艾日布林治疗对日本ER+/HER2- MBC女性患者有生存获益,且没有意外的3/4级不良事件。有趣的是,艾日布林作为ER+/HER2- MBC的任何线治疗可能都是有益的。