title: 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.
abstract: OBJECTIVE
  This phase III randomized trial (ClinicalTrials.gov identifier: NCT00337103) compared eribulin with capecitabine in patients with locally advanced or metastatic breast cancer (MBC).
  
  
  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.
  
  
  CONCLUSIONS
  In this phase III study, eribulin was not shown to be superior to capecitabine with regard to OS or PFS.
authors.affiliation: 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, Université Libre 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.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Kaufman
authors.affiliation: 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, Université Libre 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.
authors.forename: Ahmad
authors.initials: A
authors.lastname: Awada
authors.affiliation: 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, Université Libre 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.
authors.forename: Chris
authors.initials: C
authors.lastname: Twelves
authors.affiliation: 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, Université Libre 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.
authors.forename: Louise
authors.initials: L
authors.lastname: Yelle
authors.affiliation: 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, Université Libre 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.
authors.forename: Edith A
authors.initials: EA
authors.lastname: Perez
authors.affiliation: 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, Université Libre 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.
authors.forename: Galina
authors.initials: G
authors.lastname: Velikova
authors.affiliation: 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, Université Libre 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.
authors.forename: Martin S
authors.initials: MS
authors.lastname: Olivo
authors.affiliation: 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, Université Libre 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.
authors.forename: Yi
authors.initials: Y
authors.lastname: He
authors.affiliation: 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, Université Libre 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.
authors.forename: Corina E
authors.initials: CE
authors.lastname: Dutcus
authors.affiliation: 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, Université Libre 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.
authors.forename: Javier
authors.initials: J
authors.lastname: Cortes
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000627:therapeutic use; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005663:Furans / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007659:Ketones / Q000009:adverse effects / Q000627:therapeutic use*; D008875:Middle Aged; D043823:Taxoids / Q000627:therapeutic use; D055815:Young Adult; D000095662:Polyether Polyketides
chemical_list: D018943:Anthracyclines; D000964:Antimetabolites, Antineoplastic; D000069287:Capecitabine; D003841:Deoxycytidine; D005472:Fluorouracil; D005663:Furans; D007659:Ketones; D043823:Taxoids; C490954:eribulin; D000095662:Polyether Polyketides