title: Subgroup Analyses from a Phase 3, Open-Label, Randomized Study of Eribulin Mesylate Versus Capecitabine in Pretreated Patients with Advanced or Metastatic Breast Cancer.
abstract: OBJECTIVE
  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/m(2) on days 1 and 8 or twice-daily oral capecitabine 1250 mg/m(2) 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.
  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).
authors.affiliation: Section of Clinical Cancer Research, Leeds Institute of Cancer and Pathology and St James's Institute of Oncology, Leeds, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: Twelves
authors.affiliation: Medical Oncology Clinic, Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium.
authors.forename: Ahmad
authors.initials: A
authors.lastname: Awada
authors.affiliation: Vall D'Hebron University Institute of Oncology, Barcelona, Spain.; Oncology Department, Ramon y Cajal University Hospital, Madrid, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Cortes
authors.affiliation: Department of Medicine, University of Montreal, Montreal, QC, Canada.
authors.forename: Louise
authors.initials: L
authors.lastname: Yelle
authors.affiliation: Department of Oncology, Leeds Institute of Cancer and Pathology, and St James's Institute of Oncology, University of Leeds, Leeds, UK.
authors.forename: Galina
authors.initials: G
authors.lastname: Velikova
authors.affiliation: Oncology PCU, Department of Clinical Development, Eisai Inc., Woodcliff Lake, NJ, USA.
authors.forename: Martin S
authors.initials: MS
authors.lastname: Olivo
authors.affiliation: Formerly of Department of Medical Affairs, Eisai Inc., Woodcliff Lake, NJ, USA.
authors.forename: James
authors.initials: J
authors.lastname: Song
authors.affiliation: Department of Clinical Development, Oncology, Eisai Inc., Woodcliff Lake, NJ, USA.
authors.forename: Corina E
authors.initials: CE
authors.lastname: Dutcus
authors.affiliation: Section of Hematology/Oncology, Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Kaufman
keywords: advanced/metastatic breast cancer; capecitabine; eribulin; human epidermal growth factor receptor 2; subgroup analyses; survival