OBJECTIVE: To evaluate the efficacy and safety of combination of docetaxel plus epirubicin (TE) versus docetaxel plus cisplatin (TP) as first-line chemotherapy for locally advanced or metastatic breast cancer. METHODS:Eighty-eight patients were randomized into two groups with a ratio of 2:1, either to receive TE or TP regimen. The patients received docetaxel 75 mg/m2 plus epirubicin 60 mg/m2 (TE group) or docetaxel 75 mg/m2 plus cisplatin 75 mg/m2 (TP group) administrated intravenously. Both regimens were once repeated 3 weeks later. The efficacy, time to progression and safety were evaluated at the end of the second cycle. RESULTS:Complete response was achieved in 5% of TE group and 3.6% of TP. Overall (complete plus partial) response rates in TE and TP group were 48.3% and 60.7%, respectively (P = 0.2788). Disease control rates (CR + PR + SD) for TE and TP groups were 83.6% and 80%, respectively (P = 0.4899). The median time to progression (TTP) was 10 months for TE versus 8 months for TP groups (P = 0.7119). The major grade III or IV toxicities were neutropenia (66.7% in TE; 53.6% in TP, P = 0.2373); and alopecia (30.0% in TE; 10.7% in TP, P = 0.0508). CONCLUSION: Both TE and TP regimens as first-line chemotherapy were similarly effective, safe and tolerable in the treatment for locally advanced or metastatic breast cancer.
RCT Entities:
OBJECTIVE: To evaluate the efficacy and safety of combination of docetaxel plus epirubicin (TE) versus docetaxel plus cisplatin (TP) as first-line chemotherapy for locally advanced or metastatic breast cancer. METHODS: Eighty-eight patients were randomized into two groups with a ratio of 2:1, either to receive TE or TP regimen. The patients received docetaxel 75 mg/m2 plus epirubicin 60 mg/m2 (TE group) or docetaxel 75 mg/m2 plus cisplatin 75 mg/m2 (TP group) administrated intravenously. Both regimens were once repeated 3 weeks later. The efficacy, time to progression and safety were evaluated at the end of the second cycle. RESULTS: Complete response was achieved in 5% of TE group and 3.6% of TP. Overall (complete plus partial) response rates in TE and TP group were 48.3% and 60.7%, respectively (P = 0.2788). Disease control rates (CR + PR + SD) for TE and TP groups were 83.6% and 80%, respectively (P = 0.4899). The median time to progression (TTP) was 10 months for TE versus 8 months for TP groups (P = 0.7119). The major grade III or IV toxicities were neutropenia (66.7% in TE; 53.6% in TP, P = 0.2373); and alopecia (30.0% in TE; 10.7% in TP, P = 0.0508). CONCLUSION: Both TE and TP regimens as first-line chemotherapy were similarly effective, safe and tolerable in the treatment for locally advanced or metastatic breast cancer.