5-Fluorouracil, epirubicin and cyclophosphamide versus epirubicin and paclitaxel in node-positive early breast cancer: a phase-III randomized GONO-MIG5 trial

Lucia Del Mastro, Alessia Levaggi, Andrea Michelotti, Giovanna Cavazzini, Francesca Adami, Tiziana Scotto, Margherita Piras, Saverio Danese, Ornella Garrone, Antonio Durando, Valeria Accortanzo, Claudia Bighin, Loredana Miglietta, Simona Pastorino, Paolo Pronzato, Federico Castiglione, Elisabetta Landucci, PierFranco F. Conte, Paolo Bruzzi

Research output: Contribution to journalArticlepeer-review

Abstract

The study was designed to compare an anthracycline-containing regimen to a regimen combining both anthracycline and paclitaxel as adjuvant therapy for high-risk breast cancer patients. In this multicenter, randomized phase-III trial, node-positive early breast cancer patients were randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, day 1, every 3 weeks) or 4 cycles of EP (epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, day 1, every 3 weeks). The primary endpoint was overall survival (OS). Secondary endpoints included toxicity and event-free survival (EFS). From 1996 to 2001, 1055 patients were enrolled. At a median follow-up of 12.8 years, 335 deaths had been recorded. The 10-year OS was 73 % (95 % CI 69–77) in the FEC arm and 74 % (95 % CI 70–78) in the EP arm (p = 0.405). The 10-year EFS was 51 % (95 % CI 45–56) in the FEC arm and 49 % (95 % CI 44–55) in the EP arm (p = 0.572). No difference in the hazard of death was observed (HR for EP 0.85, 95 % CI 0.68–1.06, p = 0.15). Patients treated with FEC experienced more frequently nausea and vomiting, stomatitis, and leukopenia as compared to patients treated with EP. Toxicities which occurred more frequently with EP were anemia, fever, myalgias, and neurotoxicity. Our study failed to demonstrate a superiority of an adjuvant treatment with four EP as compared to six FEC in node-positive breast cancer patients.

Original languageEnglish
Pages (from-to)117-126
Number of pages10
JournalBreast Cancer Research and Treatment
Volume155
Issue number1
DOIs
Publication statusPublished - Jan 1 2016

Keywords

  • Adjuvant chemotherapy
  • Anthracycline
  • Early breast cancer
  • Node positive
  • Paclitaxel

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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