Subgroup analysis of patients with HER2-negative metastatic breast cancer in the second-line setting from a phase 3, open-label, randomized study of eribulin mesilate versus capecitabine

Breast Cancer. 2018 May;25(3):370-374. doi: 10.1007/s12282-017-0826-4. Epub 2018 Jan 4.

Abstract

This post hoc subgroup analysis of a large phase 3 study compared the efficacy and safety of eribulin versus capecitabine in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who received second-line treatment. In the phase 3 study, women with advanced/metastatic breast cancer and ≤ 3 prior chemotherapies were randomized 1:1 to eribulin mesilate 1.4 mg/m2 intravenously on days 1 and 8, or twice-daily oral capecitabine 1.25 g/m2 on days 1-14 (21-day cycles). This analysis included 392 patients. Median overall survival was longer in patients receiving eribulin compared with capecitabine (16.1 vs 13.5 months, respectively; HR 0.77, P = 0.026). Median progression-free survival and response rates were similar between arms. Both treatments had manageable safety profiles.

Keywords: Capecitabine; Eribulin; Metastatic breast cancer; Overall survival; Subgroup analysis.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Antimitotic Agents / therapeutic use*
  • Breast / pathology
  • Breast Neoplasms / drug therapy*
  • Breast Neoplasms / mortality
  • Breast Neoplasms / pathology
  • Capecitabine / therapeutic use*
  • Disease-Free Survival
  • Female
  • Furans / therapeutic use*
  • Humans
  • Ketones / therapeutic use*
  • Middle Aged
  • Receptor, ErbB-2 / metabolism
  • Treatment Outcome

Substances

  • Antimetabolites, Antineoplastic
  • Antimitotic Agents
  • Furans
  • Ketones
  • Capecitabine
  • ERBB2 protein, human
  • Receptor, ErbB-2
  • eribulin