Author/Editor     Therasse, P; Mauriac, L; Welnicka-Jaskiewicz, M; Bruning, P; Čufer, T; Bonnefoi, H; Tomiak, E; Pritchard, KI; Hamilton, A; Piccart, MJ
Title     Final results of a randomized phase III trial comparing cyclophosphamide, epirubicin, and fluorouracil with a dose-intensified epirubicin and cyclophosphamide + filgrastim as neoadjuvant treatment in locally advanced breast cancer: an EORTC-NCIC-SAKK multicenter study
Type     članek
Source     J Clin Oncol
Vol. and No.     Letnik 21, št. 5
Publication year     2003
Volume     str. 843-50
Language     eng
Abstract     Purpose: To compare the efficacy of a standard anthracycline-based regimen to a dose-intensified anthracycline regimen in locally advanced breast cancer. Patients and methods: Locally advanced breast cancer patients were randomly assigned onto a study comparing cyclophosphamide (C; 75 mg/m(2) orally days 1 to 14), epirubicin (E; 60 mg/m(2) intravenously [IV] days 1, 8), and fluorouracil (F; 500 mg/m(2) IV days 1, 8) six cycles every 28 days versus E (120 mg/m(2) IV day 1), C (830 mg/m(2) IV day 1), and granulocyte colony-stimulating factor (filgrastim; 5 micro g/kg/d subcutaneously days 2 to 13) six cycles every 14 days. The study was designed to detect a 15% improvement; that is, from 50% to 65% in median progression-free survival (PFS) in favor of the dose-intensified regimen. Results: A total of 448 patients were enrolled over a period of 3 years. The median dose intensity delivered for C and E reached, respectively, 85% and 87% of that planned in the CEF arm and 96% and 95% of that planned in the EC arm. The dose-intensified arm was slightly more emetogenic and generated more grade 3 to 4 anemia but less febrile neutropenia episodes. After a median follow-up of 5.5 years, 277 events have been reported. The median PFS was 34 and 33.7 months for CEF and EC, respectively (P =.68), and the 5-year survival rate was 53% and 51% for CEF and EC, respectively (P =.94). Conclusion: Dose-intensified EC does not provide a measurable therapeutic benefit over CEF as neoadjuvant chemotherapy for unselected locally advanced breast cancer patients.
Descriptors     BREAST NEOPLASMS
ANTINEOPLASTIC AGENTS, COMBINED
CYCLOPHOSPHAMIDE
EPIRUBICIN
FILGRASTIM
AGE FACTORS
COSTS AND COST ANALYSIS
DISEASE PROGRESSION
DISEASE-FREE SURVIVAL
DOSE-RESPONSE RELATIONSHIP, DRUG
FLUOROURACIL
QUALITY OF LIFE
SURVIVAL ANALYSIS
TREATMENT OUTCOME