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 regimen s in patients with metastatic breast cancer. Combinations of an anthracycli ne, cyclophosphamide and 5 fluorouracil are still standard in such patients . The aim of this study was to investigate the two different schedules of e pirubicin in a standard dose FEC regimen with respect to response and toxic ity. Materials and methods: Patients were randomly assigned to receive a day 1 8 schedule (5FU and CTX 500 mg/m(2) day 1, epirubicin 40 mg/m(2) day 1 and 8) or a day 1 schedule (5FU, CTX 500 mg/m(2) and epirubicin 80 mg/m(2) 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 f or the day 1 schedule. Myelosuppression was severe in the day 1 + 8 schedul e. 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 metastat ic breast cancer.