title: Epirubicin increases long-term survival in adjuvant chemotherapy of patients with poor-prognosis, node-positive, early breast cancer: 10-year follow-up results of the French Adjuvant Study Group 05 randomized trial.
abstract: OBJECTIVE
  The French Adjuvant Study Group 05 (FASG-05) showed that fluorouracil 500 mg/m2, cyclophosphamide 500 mg/m2, and epirubicin 100 mg/m2 (FEC 100) was superior to the same regimen with epirubicin 50 mg/m2 (FEC 50) in terms of disease-free survival (DFS) and overall survival (OS) in adjuvant treatment of early breast cancer. We report 10-year data on efficacy, and long-term side effects for FASG-05.
  
  
  METHODS
  We randomly assigned 565 patients to treatment with FEC 50 or FEC 100 after surgery. Postmenopausal patients also received tamoxifen for 3 years, and almost all patients (96%) also received radiotherapy.
  
  
  RESULTS
  Median follow-up was 110 months. The 10-year DFS was 45.3% (95% CI, 41.9% to 48.7%) with FEC 50 and 50.7% (95% CI, 47.3% to 54.1%) with FEC 100 (Wilcoxon P = .036; log-rank P = .08). The 10-year OS was 50.0% (95% CI, 46.7% to 53.3%) with FEC 50 and 54.8% (95% CI, 51.3% to 58.3%) with FEC 100 (Wilcoxon P = .038; log-rank P = .05). Delayed cardiac toxicity (before relapse) occurred in four patients (1.5%) in the FEC 50 arm and three patients (1.1%) in the FEC 100 arm. Cardiac toxicity after relapse occurred in six (4.3%) and five (4.1%) patients treated with FEC 50 and FEC 100, respectively.
  
  
  CONCLUSIONS
  Treatment with adjuvant FEC 100 demonstrated superior DFS and OS versus FEC 50 at 10 years of follow-up. This survival advantage was not offset by long-term complications such as cardiac toxicity and second malignancy. Given the risk-benefit ratio, FEC 100 is a more optimal regimen for long-term survival in patients with poor prognosis.
authors.affiliation: Département d'Oncologie Médicale, Centre Oscar Lambret, 3 rue Frédéric Combemale, 59020 Lille Cedex, France. j-bonneterre@o-lambret.fr
authors.forename: Jacques
authors.initials: J
authors.lastname: Bonneterre
authors.forename: Henri
authors.initials: H
authors.lastname: Roché
authors.forename: Pierre
authors.initials: P
authors.lastname: Kerbrat
authors.forename: Alain
authors.initials: A
authors.lastname: Brémond
authors.forename: Pierre
authors.initials: P
authors.lastname: Fumoleau
authors.forename: Moïse
authors.initials: M
authors.lastname: Namer
authors.forename: Marie-Josèphe
authors.initials: MJ
authors.lastname: Goudier
authors.forename: Simon
authors.initials: S
authors.lastname: Schraub
authors.forename: Pierre
authors.initials: P
authors.lastname: Fargeot
authors.forename: Isabelle
authors.initials: I
authors.lastname: Chapelle-Marcillac
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006321:Heart / Q000187:drug effects; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D016609:Neoplasms, Second Primary; D011379:Prognosis
chemical_list: D015251:Epirubicin; D003520:Cyclophosphamide; D005472:Fluorouracil