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Journal of Clinical Oncology, Vol 21, Issue 5 (March), 2003: 843-850
© 2003 American Society for Clinical Oncology

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

P. Therasse, L. Mauriac, M. Welnicka-Jaskiewicz, P. Bruning, T. Cufer, H. Bonnefoi, E. Tomiak, K. I. Pritchard, A. Hamilton, M.J. Piccart

From the European Organization for Research and Treatment of Cancer (EORTC) Data Center, Brussels, Belgium; Institut Bergonie, Bordeaux, France; Medical Academy, Gdansk, Poland; Antoni van Leeuwenhoekhuis, Amsterdam, The Netherlands; Institute of Oncology, Ljubljana, Slovenia; Hopitaux Universitaires de Genève, Geneva, Switzerland; Ottawa Regional Cancer Center, Ottawa; Toronto-Sunnybrook Regional Cancer Center, Toronto, Canada; Institut J. Bordet, Brussels, Belgium.

Address reprint requests to P. Therasse, MD, EORTC Data Center, Ave E. Mounier, 83/11, 1200 Brussels, Belgium; email: pth{at}eortc.be.

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/m2 orally days 1 to 14), epirubicin (E; 60 mg/m2 intravenously [IV] days 1, 8), and fluorouracil (F; 500 mg/m2 IV days 1, 8) six cycles every 28 days versus E (120 mg/m2 IV day 1), C (830 mg/m2 IV day 1), and granulocyte colony-stimulating factor (filgrastim; 5 µg/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.


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