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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

From the Centre Oscar Lambret, Lille; Institut Claudius Régaud, Toulouse; Centre Eugène Marquis, Rennes; Centre Léon Bérard, Lyon; Centre René Gauducheau, Nantes; Centre Antoine Lacassagne, Nice; Centre Hospitalier de Bretagne Sud, Lorient; Centre Paul Strauss, Strasbourg; Centre Georges-François Leclercq, Dijon; Pfizer, Saint-Quentin en Yvelines, France

Address reprint requests to Jacques Bonneterre, MD, Département d'Oncologie Médicale, Centre Oscar Lambret, 3 rue Frédéric Combemale, 59020 Lille Cedex, France; e-mail: j-bonneterre{at}o-lambret.fr

PURPOSE: 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.

PATIENTS AND 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.

CONCLUSION: 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.

Supported by grants from Pfizer, France. We are indebted to Dr Elisabeth Luporsi (Centre Alexis Vautrin, Nancy, France) for her statistical contribution.

Presented in part at the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003 and St Gallen Breast Cancer Conference, St Gallen, Switzerland, March 12-15, 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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