Clinical Evaluation of Eribulin Mesilate in Chinese Women with Metastatic Breast Cancer
Yuan P, et al. European Journal of Cancer, 2019, 112, 57-65.
In a randomized phase III clinical trial, eribulin mesilate was evaluated against vinorelbine for efficacy and safety in Chinese women with locally recurrent or metastatic breast cancer (MBC) previously treated with 2-5 chemotherapy regimens, including anthracyclines and taxanes. A total of 530 patients were randomized 1:1 to receive eribulin mesilate (1.4 mg/m² IV on days 1 and 8 of a 21-day cycle) or vinorelbine (25 mg/m² IV on days 1, 8, and 15). The primary endpoint was progression-free survival (PFS), with secondary endpoints including objective response rate (ORR), duration of response, and overall survival (OS). Eribulin demonstrated a superior ORR (30.7% vs. 16.9%, P < 0.001) and significantly improved PFS (HR = 0.80, P = 0.036) versus vinorelbine, despite similar median PFS durations. Notably, eribulin showed a lower incidence of treatment-emergent adverse event-related discontinuation (7.2% vs. 14.0%). These findings underscore eribulin mesilate's clinical utility as an effective and tolerable monotherapy for heavily pretreated MBC.
