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Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial 期刊论文

编号：

d297aae9-f8a0-40be-9ed3-fb254cfcaac5
作者：

Yuan, Peng(袁芃)#^[1,2]Hu, Xichun(胡夕春)#^[3]Sun, Tao^[4];Li, Wei(李薇)^[5]Zhang, Qingyuan^[6];Cui, Shude^[7];Cheng, Ying^[8];Ouyang, Quchang^[9];Wang, Xiaojia^[10];Chen, Zhendong^[11];Hiraiwa, Masahide^[12];Saito, Kenichi^[12];Funasaka, Setsuo^[12];Xu, Binghe(徐兵河)*^[1,2]
语种：

英文
期刊：

EUROPEAN JOURNAL OF CANCER ISSN：0959-8049 2019 年 112 卷 (57 - 65) ; MAY
收录：
关键词：

Progression-free survival Tolerability Locally recurrent or metastatic breast cancer Eribulin
摘要：

Introduction: The objective of this study was to evaluate the efficacy and safety of eribulin monotherapy, relative to vinorelbine, in Chinese women with locally recurrent/metastatic breast cancer (MBC).
Methods: This phase III open-label, randomised, parallel-group, multicentre clinical trial enrolled patients with locally recurrent or MBC who had had 2-5 prior chemotherapy regimens, including an anthracycline and taxane) from September 26, 2013, to May 19, 2015. Women were randomised 1:1 to receive eribulin (1.4 mg/m(2), intravenously, on day 1 andday 8) or vinorelbine (25 mg/m(2), intravenously, on day 1, day 8 and day 15) every 21 days. The primary end-point was progression-free survival (PFS). Secondary end-points included objective response rate (ORR), duration of response and overall survival (OS).
Results: Five hundred thirty women were randomised to receive eribulin (n = 264) or vinorelbine (n = 266). Improvement in PFS was observed with eribulin compared with vinorelbine (hazard ratio [HR]: 0.80, 95% confidence interval [CI]: 0.65-0.98, P = 0.036); median PFS was 2.8 months in both treatment arms. The median OS was 13.4 months with eribulin and 12.5 months with vinorelbine (HR: 1.03, 95% CI: 0.80-1.31, P = 0.838). The ORR was 30.7% (95% CI: 25.2%-36.6%) with eribulin and 16.9% (95% CI: 12.6%-22.0%) with vinorelbine (P < 0.001). Treatment-emergent adverse events leading to treatment discontinuation were less frequent with eribulin (7.2%) than with vinorelbine (14.0%).
Conclusions: Eribulin achieved statistically significantly superior PFS (and response rate) compared with vinorelbine in previously treated women with locally recurrent or MBC. Eribulin appeared to be better tolerated than vinorelbine, with no new safety signals observed. (C) 2019 The Author(s). Published by Elsevier Ltd.
推荐引用方式
GB/T 7714：

Yuan Peng,Hu Xichun,Sun Tao, et al. Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial [J].EUROPEAN JOURNAL OF CANCER,2019,112:57-65.
APA：

Yuan Peng,Hu Xichun,Sun Tao,Li Wei,&Xu Binghe.(2019).Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial .EUROPEAN JOURNAL OF CANCER,112:57-65.
MLA：

Yuan Peng, et al. "Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: A randomised clinical trial" .EUROPEAN JOURNAL OF CANCER 112(2019):57-65.
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