Epirubicin-Based Chemotherapy in Metastatic Breast Cancer Patients: Role of Dose-Intensity and Duration of Treatment

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Abstract
PURPOSE: To determine whether the duration and the dose of epirubicin modify the long-term outcome of patients with metastatic breast cancer (MBC). PATIENTS AND METHODS: Four hundred seventeen anthracycline-naive MBC patients were randomized to receive one of the following regimens: arm A: 11 cycles of fluorouracil 500 mg/m2, epirubicin 75 mg/m2, and cyclophosphamide 500 mg/m2 (FEC 75) every 21 days; arm B: four cycles of FEC 100 (same regimen but with epirubicin 100 mg/m2) then eight cycles of FEC 50 (epirubicin 50 mg/m2); and arm C: four cycles of FEC 100 then restart the same regimen at disease progression in case of prior response or stabilization. RESULTS: Hematologic toxicity was similar. Nausea/vomiting and stomatitis were significantly less frequent in arm A as was left ventricular ejection fraction decrease in arm C (A = six patients, B = five patients, and C = one patient). Six patients died of infections (A = four patients and C = two patients). After four cycles, the objective response rate (O...

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