Randomized phase II study of FEC day 1 + 8 and FEC day 1 in patients with advanced breast cancer

Background. Dose-intensive chemotherapy regimens without stem cell support have not resulted in an improved survival compared to standard dose regimens in patients with metastatic breast cancer. Combinations of an anthracycline, cyclophosphamide and 5 fluorouracil are still standard in such patients. The aim of this study was to investigate the two different schedules of epirubicin in a standard dose FEC regimen with respect to response and toxicity. Materials and methods. Patients were randomly assigned to receive a day 1 + 8 schedule (5FU and CTX 500 mg/m² day 1, epirubicin 40 mg/m² day 1 and 8) or a day 1 schedule (5FU, CTX 500 mg/m² and epirubicin 80 mg/m² day 1), q day 21, both given without hematopoietic growth factors. A total of 104 eligible patients were analyzed, 52 in each arm. Results and conclusions. A significantly higher relative dose-intensity was found for the day 1 schedule compared to the day 1 + 8 schedule. Although the trial was not set up to reliably detect a difference in response rate, this difference in relative dose-intensity in favour of the day 1 schedule does not suggest any improvement in response rate or duration of response for the day 1 schedule. Myelosuppression was severe in the day 1 + 8 schedule. We conclude that a day 1 + 8 FEC schedule has no advantage over a day 1 FEC schedule without hematopoietic growth factors in patients with metastatic breast cancer.