title: 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.
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.
authors.affiliation: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Via Maroncelli 34/36, 47014 Meldola, Italy. segronco@ausl.fo.it
authors.forename: Dino
authors.initials: D
authors.lastname: Amadori
authors.forename: Oriana
authors.initials: O
authors.lastname: Nanni
authors.forename: Annalisa
authors.initials: A
authors.lastname: Volpi
authors.forename: Donata
authors.initials: D
authors.lastname: Casadei Giunchi
authors.forename: Maurizio
authors.initials: M
authors.lastname: Marangolo
authors.forename: Lorenzo
authors.initials: L
authors.lastname: Livi
authors.forename: Alberto
authors.initials: A
authors.lastname: Ravaioli
authors.forename: Andrea Paolo
authors.initials: AP
authors.lastname: Rossi
authors.forename: Angelo
authors.initials: A
authors.lastname: Gambi
authors.forename: Stefano
authors.initials: S
authors.lastname: Luzi Fedeli
authors.forename: Davide
authors.initials: D
authors.lastname: Perroni
authors.forename: Emanuela
authors.initials: E
authors.lastname: Scarpi
authors.forename: Aldo
authors.initials: A
authors.lastname: Becciolini
authors.forename: Rosella
authors.initials: R
authors.lastname: Silvestrini
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D049109:Cell Proliferation / Q000187:drug effects; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D007558:Italy; D053208:Kaplan-Meier Estimate; D008198:Lymph Nodes / Q000473:pathology; D008727:Methotrexate / Q000008:administration & dosage; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate