Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane

• Published in: Journal of clinical oncology Vol. 33; no. 6; pp. 594 - 601
• Main Authors: Kaufman, Peter A, Awada, Ahmad, Twelves, Chris, Yelle, Louise, Perez, Edith A, Velikova, Galina, Olivo, Martin S, He, Yi, Dutcus, Corina E, Cortes, Javier
• Format: Journal Article
• Language: English
• Published: United States American Society of Clinical Oncology 20.02.2015
• Subjects: Adult; Aged; Aged, 80 and over; Anthracyclines - therapeutic use; Antimetabolites, Antineoplastic - therapeutic use; Breast Neoplasms - drug therapy; Capecitabine; Deoxycytidine - adverse effects; Deoxycytidine - analogs & derivatives; Deoxycytidine - therapeutic use; Female; Fluorouracil - adverse effects; Fluorouracil - analogs & derivatives; Fluorouracil - therapeutic use; Furans - adverse effects; Furans - therapeutic use; Humans; Ketones - adverse effects; Ketones - therapeutic use; Middle Aged; ORIGINAL REPORTS; Taxoids - therapeutic use; Young Adult
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2013.52.4892

This phase III randomized trial (ClinicalTrials.gov identifier: NCT00337103) compared eribulin with capecitabine in patients with locally advanced or metastatic breast cancer (MBC). Women with MBC who had received prior anthracycline- and taxane-based therapy were randomly assigned to receive eribulin or capecitabine as their first-, second-, or third-line chemotherapy for advanced/metastatic disease. Stratification factors were human epidermal growth factor receptor-2 (HER2) status and geographic region. Coprimary end points were overall survival (OS) and progression-free survival (PFS). Median OS times for eribulin (n = 554) and capecitabine (n = 548) were 15.9 and 14.5 months, respectively (hazard ratio [HR], 0.88; 95% CI, 0.77 to 1.00; P = .056). Median PFS times for eribulin and capecitabine were 4.1 and 4.2 months, respectively (HR, 1.08; 95% CI, 0.93 to 1.25; P = .30). Objective response rates were 11.0% for eribulin and 11.5% for capecitabine. Global health status and overall quality-of-life scores over time were similar in the treatment arms. Both treatments had manageable safety profiles consistent with their known adverse effects; most adverse events were grade 1 or 2. In this phase III study, eribulin was not shown to be superior to capecitabine with regard to OS or PFS.