Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies

Breast Cancer Res Treat. 2014 Dec;148(3):553-61. doi: 10.1007/s10549-014-3144-y. Epub 2014 Nov 8.

Abstract

Data from two phase 3 studies of eribulin were pooled in analyses initially requested by the European Medicines Agency to assess whether specific patient subgroups, previously treated with an anthracycline and a taxane, benefited from eribulin. Study 305/EMBRACE included women after two-to-five lines of chemotherapy for advanced breast cancer who were randomized to eribulin mesylate (1.4 mg/m(2) on days 1 and 8 every 21 days) or treatment of physician's choice. In Study 301, patients who had received up to two prior chemotherapy regimens for advanced disease were randomized to eribulin (as above) or capecitabine (1.25 g/m(2) b.i.d. on days 1-14 every 21 days). In the pooled population, overall survival (OS), progression-free survival and response rates were analysed in the intent-to-treat population and selected subgroups. Overall, 1,062 patients were randomized to eribulin and 802 patients to control. Median OS was 15.2 months with eribulin versus 12.8 months with control (hazard ratio [HR] 0.85; 95% CI 0.77, 0.95; P = 0.003). In all subgroups assessed, OS data favoured eribulin; significant improvements occurred in some subgroups, notably in women with human epidermal growth factor receptor 2 (HER2)-negative disease (HR 0.82; P = 0.002), although the effect in those with HER2-negative but hormone-receptor-positive disease did not reach statistical significance; benefits were also seen, among others, in those with estrogen-receptor-negative and triple-negative disease. Eribulin improves OS in various patient subgroups with advanced/metastatic breast cancer who had previously received an anthracycline and a taxane. Women with HER2-negative disease are among those who may obtain benefit from eribulin.

Publication types

  • Clinical Trial, Phase III
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anthracyclines / administration & dosage*
  • Anthracyclines / adverse effects
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / genetics
  • Breast Neoplasms / pathology
  • Bridged-Ring Compounds / administration & dosage*
  • Bridged-Ring Compounds / adverse effects
  • Capecitabine
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / analogs & derivatives
  • Disease-Free Survival
  • Female
  • Fluorouracil / administration & dosage
  • Fluorouracil / analogs & derivatives
  • Furans / administration & dosage*
  • Furans / adverse effects
  • Humans
  • Ketones / administration & dosage*
  • Ketones / adverse effects
  • Middle Aged
  • Neoplasm Metastasis
  • Receptor, ErbB-2 / genetics
  • Taxoids / administration & dosage*
  • Taxoids / adverse effects

Substances

  • Anthracyclines
  • Bridged-Ring Compounds
  • Furans
  • Ketones
  • Taxoids
  • Deoxycytidine
  • taxane
  • Capecitabine
  • ERBB2 protein, human
  • Receptor, ErbB-2
  • eribulin
  • Fluorouracil