Final results of a randomized phase III trial of docetaxel, carboplatin and 5FU versus epirubicin, cisplatin and 5FU for locally advanced gastric cancer

4014 Background: Docetaxel-based chemotherapy appears to have considerable promise in advanced gastric cancer. In phase II studies of single agent docetaxel, response rates (RRs) of 17% to 24% have been achieved in previously untreated patients. The aim of this study is to compare the efficacy and tolerability of Docetaxel, and fluorouracil Carboplatin (DF-Carbo regimen) with that of the reference protocol of epirubicin, cisplatin and fluorouracil (ECF regimen). Methods: Between 1999 and 2004, a total of 64 patients with metastatic adenocarcinoma of the stomach were randomized and analyzed for toxicity, tumor response, progression-free and overall survival. DF-Carbo (Docetaxel 75 mg/m2 D1, Carboplatin AUC6 D2 and continuous infusion 5FU 1200 mg/m2/day D1–3) every 3 weeks. 30 patients were taken DF-carbo regimen, while 34 patients were in ECF arm. G-CSF 5 microg/kg SC was also given on days 4 through 9 prophylactically to all patients. Results: The overall response rate was 47.1% with ECF, and 66.7% with D...