(ChemotherapyAdvisor) – In patients with operable breast cancer treated with capecitabine plus docetaxel followed by fluorouracil, epirubicin, and cyclophosphamide (FEC), no difference in efficacy was observed when compared with those treated with weekly paclitaxel followed by FEC, a study published in the Journal of Clinical Oncology online February 13 has found.
The Phase 3 study randomly assigned 601 patients with clinical stages I to IIIC breast cancer to weekly paclitaxel 80mg/m2 for 12 weeks followed by fluorouracil 500mg/m2, epirubicin 100mg/m2, and cyclophosphamide 500mg/m2 every 3 weeks for 4 cycles or docetaxel 75mg/m2 on day 1 plus capecitabine 1,500 mg/m2 days 1–14 every 3 weeks for 4 cycles followed by FEC for 4 cycles. Patients were stratified by preoperative vs. adjuvant chemotherapy.
At a median follow-up of 50 month, no improvement in relapse-free survival was observed between the two arms; 90.7% for weekly paclitaxel followed by FEC vs. 87.5% for capecitabine/docetaxel plus FEC. Pathologic complete response rate for patients who received treatment preoperatively was 16.4% for the weekly paclitaxel arm vs. 19.8% for capecitabine/docetaxel. Rates of breast-conserving surgery were similar between the two groups. Patients who received capecitabine/docetaxel had a significantly higher incidence of stomatitis, hand-foot syndrome, and neutropenic infection.