Final results of randomized phase II trial of docetaxel, carboplatin and 5 fluorouracil versus epirubicin, cisplatin and fluorouracil for locally advanced gastric cancer

Abstract EN

Introduction 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.

Purpose 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).

Patients and Methods Between 1999 and 2004, a total of 64 patients with advanced adenocarcinoma of the stomach were randomized and analyzed for toxicity, tumor response, progression-free and overall survival.

Thirty-four patients received ECF (Epirubicin 50 mg / m2 day 1, Cisplatin 60 mg / m2 day 1 and 5FU 1200 mg / m2 / day) and thirtyy patients received DF-Carbo (Docetaxel 75 mg / m2 day 1, Carboplatin AUC6 day 2 and continuous infusion 5-FU 1200 mg / m2/day day 1-3 every 3 weeks).

Results The overall response rate was 46% with ECF, and 67% 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 & 20% for the DF-Carbo regimen are, (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.

Conclusion 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.