Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer

• Published in: Breast cancer : basic and clinical research Vol. 2016; no. 10; pp. 77 - 84
• Main Authors: Twelves, Chris, Awada, Ahmad, Cortes, Javier, Yelle, Louise, Velikova, Galina, Olivo, Martin S., Song, James, Dutcus, Corina E., Kaufman, Peter A.
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publishing 01.01.2016; SAGE Publications; Sage Publications Ltd; Libertas Academica
• Subjects: Breast cancer; Chemotherapy; Epidermal growth factor; Metastasis; Original Research; capecitabine; subgroup analyses; advanced/metastatic breast cancer; human epidermal growth factor receptor 2; eribulin; survival
• ISSN: 1178-2234; 1178-2234
• DOI: 10.4137/BCBCR.S39615

Purpose and Methods Our secondary analyses compared survival with eribulin versus capecitabine in various patient subgroups from a phase 3, open-label, randomized study. Eligible women aged ≥18 years with advanced/metastatic breast cancer and ≤3 prior chemotherapies (≤2 for advanced/metastatic disease), including an anthracycline and taxane, were randomized 1:1 to intravenous eribulin mesylate 1.4 mg/m2 on days 1 and 8 or twice-daily oral capecitabine 1250 mg/m2 on days 1–14 (21-day cycles). Results In the intent-to-treat population (eribulin 554 and capecitabine 548), overall survival appeared longer with eribulin than capecitabine in various subgroups, including patients with human epidermal growth factor receptor 2-negative (15.9 versus 13.5 months, respectively), estrogen receptor-negative (14.4 versus 10.5 months, respectively), and triple-negative (14.4 versus 9.4 months, respectively) disease. Progression-free survival was similar between the treatment arms. Conclusions Patients with advanced/metastatic breast cancer and human epidermal growth factor receptor 2-, estrogen receptor-, or triple-negative disease may gain particular benefit from eribulin as first-, second-, and third-line chemotherapies. Trial Registration (Primary Study) This study reports the subgroup analyses of eribulin versus capecitabine from a phase 3, open-label, randomized study (www.clinicaltrials.gov; ClinicalTrials.gov identifier: NCT00337103).