[Efficacy and safety evaluation of docetaxel plus oxaliplatin and capecitabine in the treatment of advanced gastric adenocarcinoma: a single center non-controlled phase II clinical trial].

OBJECTIVE

To assess the efficacy and safety of docetaxel plus oxaliplatin and capecitabine (DOX) in the treatment of advanced gastric adenocarcinoma.

METHODS

A total of 30 patients were recruited to receive DOX regimen (docetaxel 75 mg/m(2) day 1, oxaliplatin 130 mg/m(2) day 1, and capecitabine 1000 mg/m(2) bid d1-14, repeated every 3 weeks). Only those who completed at least 2 cycles were assessed.

RESULTS

The number of patients with complete response, partial response, stable disease and progressive disease were 1, 2, 25 and 2, respectively. The objective response rate was 10.0%(3/30) and the disease control rate was 93.3%(28/30). After a median follow-up of 261 days, the median progression free survival and overall survival time were 197 days and 466 days, respectively. The most common grade III to IV toxicity was hematologic toxicity. The percentage of patients with grade III to IV leucopenia, neutropenia and febrile neutropenia were 60.0%, 43.3% and 30.0%, respectively. The most common grade III to IV non-hematologic toxicity was fatigue, nausea, vomiting, anorexia, diarrhea, and hand-foot syndrome.

CONCLUSIONS

DOX regimen demonstrates promising efficacy in the treatment of advanced gastric adenocarcinoma. The associated toxicity can be well tolerated and controlled. Large scale clinical trial is necessary to obtain further evidence.