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 |