Eribulin improved overall survival (OS) in ≥3 line treatment of MBC pts. In a large retrospective study, short disease-free interval (DFI) and prior taxane therapy have been associated with worse OS in pts receiving first-line chemotherapy for HER2[-] MBC. The aim of MERIBEL trial is to evaluate the efficacy and safety of eribulin as first-line therapy for HER2[-] MBC pts with these poor prognostic factors.
Phase II, multicenter, single arm, trial. Eribulin (1.23 mg/m2) as single-agent was administered on days 1 and 8 of 21 day cycles until progression or unacceptable toxicity. Principal selection criteria: (1) HER2[-] pts without prior chemotherapy for MBC; (2) prior taxane therapy (≥4 cycles) for early BC; (3) less than 36 months* (mo) between the last taxane cycle and relapse; (4) RECIST v1.1 evaluable disease; (5) no symptomatic brain involvement. (*) Amendment to 48 mo. Primary outcome was time to progression (TTP). Secondary endpoints included OS, progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR) and toxicity. We included 53 women from 61 pts recruited between SEP/2013 to MAR/2015 across 12 sites and 2 countries.
Median age 51 years [range 23-83]; 50.9% were ECOG 0; 45.3% were triple-negative; 84.9% received prior anthracyclines. Median DFI was 15.7 mo [0.1-46.5]; and 52.8% had visceral metastases (11.3% with ≥3 involved organ sites). Median follow-up was 12.7 mo [0.2 – 30.5]. Median TTP was 4.1 mo [95%CI 2.2-6], median PFS was 4.3 mo [2.2-6.5], and median OS has not been reached yet. The 1-year TTP, PFS and OS rates were 16.2%, 24.3%, and 65.9%, respectively. The ORR was 20.8% and CBR, 26.4%. Eribulin all grades and 3/4 adverse events (AEs) were reported in 96.2% and 71.7% of the pts, respectively. The most common grade 3/4 AEs were neutropenia (28.3%), leukopenia (17%), peripheral neuropathy (5.7%) and asthenia (5.7%). One patient experienced febrile neutropenia. Percentages of pts with AEs leading to treatment discontinuation, reduction, or delay were 15.1%, 9.4%, and 26.4%, respectively.
Eribulin is effective and safe as first-line therapy for aggressive taxane-resistant HER2[-] MBC pts.
Clinical trial identification
Legal entity responsible for the study
Medica Scientia Innovation Research - MEDSIR ARO
J. Cortes Castan: Javier Cortés has been member on advisory boards of Roche, Celgene, AstraZeneca and Celestial and has received honoraria from Roche, Novartis and Eisai.
A. Llombart-Cussac: Antonio Llombart-Cussac has received honoraria for lectures and advisory boards from Roche, GlaxoSmithKline, Novartis, Celgene, Eisai and AstraZeneca and research funding from GlaxoSmithKline, Sanofi and Puma Biotechnology
All other authors have declared no conflicts of interest.