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 DF-Carbo regimen. The median survival was 8.7 months with ECF and 12.4 months with DF-Carbo regimen (P = 0.0005). The 2-year survival rates were 14% for the ECF arm, and 20% for the DF-Carbo regimen arm (P = 0.03). Histologically complete surgical resection following chemotherapy was achieved in two patients in the ECF arm (pathological complete responses to chemotherapy) and five patients in the DF-Carbo regimen arm. Conclusions: The DF-Carbo regimen resulted in a response and survival advantage compared with ECF regimen chemotherapy. The probability of long-term survival following surgical resection of residual disease is increased by this treatment. The high response rates seen with DF-Carbo regimen support its use in the neoadjuvant setting. It is possible that data from this randomized study confirms the value of docetaxel-based chemotherapy in advanced gastric cancer and that docetaxel combinations will also be effective in the multidisciplinary efforts to cure earlier stage No significant financial relationships to disclose.