A multicenter phase III prospective randomized trial of high-dose epirubicin in combination with cyclophosphamide (EC) versus docetaxel followed by EC in node-positive breast cancer. GOIM (Gruppo Oncologico Italia Meridionale) 9902 study

P. Vici, M. Brandi, F. Giotta, P. Foggi, F. Schittulli, L. Di lauro, N. Gebbia, B. Massidda, G. Filippelli, D. Giannarelli, A. Di benedetto, M. Mottolese, G. Colucci, M. Lopez

Research output: Contribution to journalArticle

Abstract

Background: The Gruppo Oncologico Italia Meridionale 9902 trial compared four cycles of high-dose epirubicin plus cyclophosphamide (EC) with four cycles of docetaxel (Taxotere, D) followed by four cycles of EC as adjuvant treatment of node-positive breast cancer. Patients and methods: Patients were randomly assigned to EC (E 120 mg/m. 2, C 600 mg/m. 2, arm A) for four cycles or four cycles of D (100 mg/m. 2) followed by four cycles of EC (arm B), both regimens every 21 days. Hormone receptor-positive patients were given hormonal therapy for 5 years. Primary end point was 5-year disease-free survival (DFS). Secondary objectives were overall survival (OS) and safety. Results: There were 750 patients enrolled. With a median follow-up of 64 months, 5-year DFS was 73.4% in both arms, and 5-year OS was 89.5% versus 90.7% in arm A and B [hazard ratio was 0.99 (95% confidence interval for DFS 0.75-1.31; P = 0.95)], respectively. Grade 3-4 toxicity was more common in arm B. Conclusions: This study did not show advantages from the addition of docetaxel to high-dose EC as adjuvant chemotherapy in node-positive breast cancer. The small sample size and low number of DFS events may have limited the ability to observe statistically significant difference between the two arms.

Original languageEnglish
Pages (from-to)1121-1129
Number of pages9
JournalAnnals of Oncology
Volume23
Issue number5
DOIs
Publication statusPublished - May 2012

Keywords

  • Adjuvant chemotherapy
  • Docetaxel
  • Early breast cancer

ASJC Scopus subject areas

  • Oncology
  • Hematology

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