Phase II study of docetaxel plus epirubicin versus docetaxel plus cisplatin as first-line chemotherapy for treatment of advanced breast cancer (CHN TAX-618)

Abstract

10535 Background: The combination of docetaxel plus epirubicin (TE) have demonstrated a significant activity in advance breast cancer (ABC) as first-line chemotherapy. In the meantime, some emerging literatures suggest that docetaxel-cisplatin (TP) combination has a powerful synergistic interaction with less cardiotoxicity. The main objectives of this multicenter study are to evaluate the efficacy and safety of TE versus TP. Methods: From August 2003 to February 2005, 80 patients with at least one measurable lesion were randomized with ratio of 2:1 to receive TE or TP as as first-line chemotherapy. Dosages were as follows: docetaxel 75 mg/m2 plus epirubicin 60 mg/m2 or docetaxel 75 mg/m2 plus cisplatin 75 mg/m2 intravenously once every 3 weeks for a maximum of 6 cycles. Baseline characteristics were well balanced. Results: A total of 55 patients were assigned to TE (median age 48 yearas) and 25 patients were treated with TP (median age 50 yearas). The same of median 4 cycles treatment were administered for two arms. A complete clinical response was observed in 3.6% and 4.0% of patients treated with TE and TP, respectively (P = 1.00). Overall (complete and partial) clinical response rates for TE and TP were 48% and 56%, respectively (P =0.469). Disease control rates (CR + PR + SD) for TE and TP were 83.6% and 80%, respectively (P = 0.755). The median TTP were TE: 10.8months,TP: 11.2 months days (P = 0.247). Grade 3/4 toxicities included: nausea/vomiting (16.3% TE; 12.0% TP); diarrhea (1.8% TE; 0% TP); alopecia (32.7% TE; 12.0% TP); anemia (1.8% TE; 4.0%TP); neutropenia (65.5% TE; 4.8% TP); febrile neutropenia (3.6% TE; 0% TP). Conclusions: Both TE and TP were active and tolerant regimens for ABC. While there may have been a trend toward lower toxicities in favor of the docetaxel/cisplatin combination, although no significant difference was observed during our study. No significant financial relationships to disclose.

A phase II study of gemcitabine plus paclitaxel in patients with metastatic breast cancer and prior anthracycline treatment

“…In a recent randomized controlled trial of 88 Chinese patients with advanced breast cancer or MBC receiving either docetaxel-epirubicin or docetaxelcisplatin, neutropenia was reported in 67 and 54% of patients, respectively. 36 Because this was a single arm study, there was no appropriate comparative arm against which the efficacy and safety of gemcitabine-paclitaxel could be compared. However, the efficacy and safety of gemcitabinepaclitaxel in this group of Chinese MBC patients appears to be comparable to that of paclitaxel monotherapy 9 and the global phase III study population in terms of overall objective response, 12-month OS and toxicity profile.…”