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Medline ® Abstract for Reference 35

of 'Systemic treatment of metastatic breast cancer in women: Chemotherapy'

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.
Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, Olivo MS, He Y, Dutcus CE, Cortes J
J Clin Oncol. 2015;33(6):594. Epub 2015 Jan 20.
PURPOSE: This phase III randomized trial (ClinicalTrials.gov identifier: NCT00337103) compared eribulin with capecitabine in patients with locally advanced or metastatic breast cancer (MBC).
PATIENTS AND METHODS: 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).
RESULTS: 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.
CONCLUSION: In this phase III study, eribulin was not shown to be superior to capecitabine with regard to OS or PFS.
Peter A. Kaufman, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Edith A. Perez, Mayo Clinic, Jacksonville, FL; Martin S. Olivo, Yi He, and Corina E. Dutcus, Eisai, Woodcliff Lake, NJ; Ahmad Awada, Medical Oncology Clinic, Jules Bordet Institute, UniversitéLibre de Bruxelles, Brussels, Belgium; Chris Twelves and Galina Velikova, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, Leeds, United Kingdom; Louise Yelle, University of Montreal, Montreal, Quebec, Canada; and Javier Cortes, Vall D'Hebron University Institute of Oncology, Barcelona, Spain. Peter.A.Kaufman@hitchcock.org.