Phase II, Multicenter, Single-arm Trial of Eribulin as First-line Therapy for Patients With Aggressive Taxane-pretreated HER2-Negative Metastatic Breast Cancer: The MERIBEL Study.

Abstract:

BACKGROUND:Eribulin has efficacy in patients with progression after ≥ 1 chemotherapeutic regimen for metastatic breast cancer (MBC). A short disease-free interval (DFI) and previous use of taxanes in the neoadjuvant or adjuvant setting have been associated with worse outcomes for patients receiving first-line chemotherapy for HER2-negative MBC. The aim of the present trial was to evaluate the efficacy and safety of eribulin as first-line therapy for patients with HER2-negative MBC with these poor prognostic factors. PATIENTS AND METHODS:Eribulin monotherapy was administered until disease progression or unacceptable toxicity. The principal selection criteria were HER2 negativity without previous chemotherapy for MBC, the previous use of taxanes for early-stage breast cancer, and a DFI of < 36 months (subsequently amended to 48 months). The primary endpoint was the investigator-assessed time to progression. The secondary endpoints included overall survival, progression-free survival, objective response rate, clinical benefit rate, duration of response, and toxicity profile. A total of 53 patients were enrolled and received ≥ 1 dose of eribulin. RESULTS:The median patient age was 47 years (range, 23-82.8 years). The median DFI was 15.7 months (range, 0.1-46.4 months). The median investigator-assessed time to progression was 4.1 months (range, 0.2-27.8 months; 95% confidence interval, 3.2-6.2 months). The objective response and clinical benefit rate was 20.8% and 26.4%, respectively. All-grade and grade 3/4 adverse events developed in 96.2% and 69.8% of patients, respectively. The most common treatment-related adverse events were neutropenia, leukopenia, alopecia, nausea, and anemia. CONCLUSION:Eribulin is effective and safe as first-line therapy for aggressive taxane-pretreated HER2-negative MBC.

journal_name

Clin Breast Cancer

journal_title

Clinical breast cancer

authors

Ortega V,Antón A,Garau I,Afonso N,Calvo L,Fernández Y,Martínez-García M,Blanco E,Zamora P,García M,Illarramendi JJ,Rodríguez Sánchez CA,Sampayo M,Aguirre E,Pérez-García JM,Cortés J,Llombart-Cussac A

doi

10.1016/j.clbc.2018.12.012

subject

Has Abstract

pub_date

2019-04-01 00:00:00

pages

105-112

issue

2

eissn

1526-8209

issn

1938-0666

pii

S1526-8209(17)30144-1

journal_volume

19

pub_type

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