Phase III randomized multicenter study on the effects of adjuvant CMF in patients with node-negative, rapidly proliferating breast cancer: Twelve-year results and retrospective subgroup analysis

Dino Amadori, Oriana Nanni, Annalisa Volpi, Donata Casadei Giunchi, Maurizio Marangolo, Lorenzo Livi, Alberto Ravaioli, Andrea Paolo Rossi, Angelo Gambi, Stefano Luzi Fedeli, Davide Perroni, Emanuela Scarpi, Aldo Becciolini, Rosella Silvestrini

Research output: Contribution to journalArticle

Abstract

The randomized multicenter study on rapidly proliferating breast cancer, assessed according to thymidine labelling index (TLI), was activated at the end of the 1980s. The present work investigated whether and to what degree the short-term advantages observed from adjuvant CMF (cyclophosphamide, methotrexate, 5-fluorouracil) were maintained at a longer follow-up. Two hundred and eighty-one patients with node-negative and high TLI tumors were randomized to receive six cycles of CMF or no further treatment. At a median follow-up of 12 years, CMF produced a 25% and 20% relative reduction in relapse and death cumulative incidence, respectively. A breakdown analysis identified a subgroup of patients with intermediate proliferating tumors for whom a 70% and 73% reduction in relapse and death was observed in the intention-to-treat population. An even higher reduction of 80% and 84% in relapse and death was seen for the patients who had received the full CMF dose. We identified a subgroup of patients with intermediate proliferating tumors in whom the high benefit obtained from adjuvant CMF was maintained at a long-term follow up.

Original languageEnglish
Pages (from-to)259-264
Number of pages6
JournalBreast Cancer Research and Treatment
Volume108
Issue number2
DOIs
Publication statusPublished - Mar 2008

Keywords

  • Adjuvant CMF
  • High-risk node-negative breast cancer
  • Randomized study
  • Tumor Proliferative activity

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Amadori, D., Nanni, O., Volpi, A., Casadei Giunchi, D., Marangolo, M., Livi, L., Ravaioli, A., Rossi, A. P., Gambi, A., Luzi Fedeli, S., Perroni, D., Scarpi, E., Becciolini, A., & Silvestrini, R. (2008). Phase III randomized multicenter study on the effects of adjuvant CMF in patients with node-negative, rapidly proliferating breast cancer: Twelve-year results and retrospective subgroup analysis. Breast Cancer Research and Treatment, 108(2), 259-264. https://doi.org/10.1007/s10549-007-9593-9