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

Abstract

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 2e5 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 and

A nationwide, multicenter retrospective study on the effectiveness and safety of eribulin in Korean breast cancer patients (REMARK)

“…Based on the findings of two phase III studies, EMBRACE [ 13 ] and 301 [ 14 ], eribulin was approved in many countries, including Korea, for the treatment of advanced or metastatic breast cancer in patients who have been previously treated with at least two lines of chemotherapy, including an anthracycline and a taxane [ 15 , 16 ]. Eribulin was also recently approved in China for the treatment of locally advanced or metastatic breast cancer, based on the results of the 304 study [ 17 ].…”

“…Pooled analysis of EMBRACE and 301 demonstrated a significant improvement in OS among patients with HER2-negative and triple-negative disease treated with eribulin [ 11 ]. In the recent 304 study, a multicenter, open-label, randomized phase III trial, which evaluated eribulin versus vinorelbine in 530 Chinese patients with locally recurrent or metastatic breast cancer previously treated with chemotherapy regimens, including an anthracycline and a taxane, eribulin demonstrated a statistically significant extension in PFS (primary endpoint) over vinorelbine according to independent imaging review (hazard ratio: 0.80; 95% confidence interval [CI]: 0.65–0.98; p = 0.036) [ 17 ].…”

“…While these studies were the basis of approval for eribulin, they consisted primarily of Western patients and the only clinical study data of Asian patients were from Japanese metastatic breast cancer patients and, more recently, one study (304 study) in Chinese patients [ [13] , [14] , [15] , [16] , [17] , [18] , [19] , [20] , [21] ]. To address the shortage of data from Asian patients, a phase IV clinical study, ESKIMO, was conducted in Korean patients [ 22 ].…”

Effectiveness and healthcare costs of eribulin versus capecitabine among metastatic breast cancer patients in Taiwan

“…With regards to HR status, among the HR-population in the Study 301, although the OS and PFS of the Eribulin group were longer than those of the capecitabine group, the difference did not reach statistical significance (p = 0.05 and 0.82, respectively) [ 25 ]. Moreover, in two other clinical trials (eribulin vs. physician choice in one; eribulin vs. vinorelbine in the other), the efficacy of eribulin in patients with positive hormone receptor is similar to that in patients with negative hormone receptor status [ 26 , 27 ]. In a further analysis, we explored the potential effect of HR and HER2 status using multiple regression analysis, but no statistical significance was observed.…”

First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: Efficacy and safety in the GINECO phase II ESMERALDA study

“…The microtubule inhibitor eribulin is an established therapy for MBC in later lines, based on results of the EMBRACE [15] and Study 301 [16] randomized phase III trials and, more recently, a randomized phase III trial versus vinorelbine in Chinese patients with anthracycline-and taxane-pretreated MBC [17]. Most data for eribulin have been generated in patients with heavily pretreated MBC.…”