Randomised phase III trial of FEC120 vs EC-docetaxel in patients with high-risk node-positive primary breast cancer: Final survival analysis of the ADEBAR study

W. Janni, N. Harbeck, B. Rack, D. Augustin, J. Jueckstock, A. Wischnik, K. Annecke, C. Scholz, J. Huober, T. Zwingers, T. W.P. Friedl, M. Kiechle

Research output: Contribution to journalArticlepeer-review

10 Scopus citations

Abstract

Background:Taxane-containing adjuvant chemotherapy has been established as standard treatment in node-positive breast cancer. This study compared efficacy and tolerability of epirubicin (E)/cyclophosphamide (C) followed by docetaxel (Doc) with a dose-dense 5-fluorouracil (F)+E+ C regimen.Methods:The ADEBAR study was a randomised phase III trial for women with primary invasive breast cancer and ≥4 metastatic axillary lymph nodes (n=1364). Treatment consisted of four 21-day cycles of E plus C, followed by four 21-day cycles of Doc (EC-Doc), or six 28-day cycles of E plus F plus C (FEC120).Results:Disease-free survival (DFS) was similar in the two treatment arms as shown by multivariate Cox regression adjusted for other prognostic factors (EC-Doc vs FEC120, hazard ratio (HR): 1.087; 95% confidence interval (CI): 0.878-1.346, P=0.444). In addition, there was no significant difference in overall survival (OS) between the two groups (HR: 0.974; 95% CI: 0.750-1.264, P=0.841). Haematologic toxicity was more common in FEC120 recipients; non-haematologic toxicities occurred more frequently in the EC-Doc arm. The serious adverse event rate was significantly higher in the FEC120 group (29.7% vs 22.5%).Conclusions:EC-Doc provides a feasible and effective alternative therapy option to FEC120 with a different safety profile in this high-risk breast cancer cohort.

Original languageEnglish
Pages (from-to)863-871
Number of pages9
JournalBritish Journal of Cancer
Volume114
Issue number8
DOIs
StatePublished - 12 Apr 2016
Externally publishedYes

Keywords

  • ADEBAR trial
  • FEC120 vs EC-Doc
  • efficacy
  • high-risk primary breast cancer
  • safety

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