A randomized study of individually tailored toxicity-based dosage of fluorouracil-epirubicin-cyclophosphamide chemotherapy (FEC) for early breast cancer.

1017 Background: Dosage of chemotherapy based on body surface area (BSA) does not consider differences in drug clearance and sensitivity, which could result in over- or under-treatment. Several retrospective studies have demonstrated a worse outcome in patients not achieving leucopenia during adjuvant chemotherapy. The SBG 2000−1 trial is the first adjuvant randomized trial designed to compare individually dosed chemotherapy based on grade of leucopenia to standard dosed chemotherapy based on BSA only. Methods: Patients with early breast cancer were included and received the first cycle at a standard dose of FEC (fluorouracil 600 mg/m2, epirubicin 60 mg/m2, cyclophophamide 600 mg/m2). Patients with nadir leucopenia grade 0−2 after first cycle were randomized between either 6 tailored FEC with increased doses (E 75−90 mg/m2, C 900−1200 mg/m2) or continuos treatment with 6 standard FEC. Patients with nadir leucopenia grade 3−4 after the first cycle were not randomized but represented a second control group ...