Phase II Study of Docetaxel and Cisplatin as First-line Chemotherapy in Patients with Recurrent or Metastatic Gastric Cancer

Abstract

PURPOSE: Palliative chemotherapy for patients with recurrent or metastatic gastric cancer has been shown to have a survival benefit. Docetaxel monotherapy has achieved appreciable results for treating gastric cancer. We investigated the clinical efficacy and feasibility of a docetaxel and cisplatin combination regimen for patients suffering with recurrent or metastatic gastric cancer. MATERIALS AND METHODS: Patients with histologically proven, bidimensionally measurable lesions of recurrent or metastatic gastric cancer, and they had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 and no prior palliative chemotherapy were eligible for this study. The combination chemotherapy regimen consisted of docetaxel 75 mg/m(2) plus cisplatin 75 mg/m(2) on day 1, and this was repeated every 3 weeks until disease progression. RESULTS: 32 patients were enrolled from 2002 to 2005. The objective response rate was 31.3% (95% confidence interval (CI): 14.2 approximately 48.2%) with no CR. The disease control rate was 59.4%. At a median follow up of 38.9 months, the median overall survival was 7.4 months (95% CI: 6.3 approximately 8.5). The median time to progression was 4.7 months (95% CI: 3.1 approximately 6.3). During a total of 106 cycles, grade 3 or 4 hematological toxicities were observed as follows: neutropenia (39 of 106 cycles) and anemia (3 of 106 cycles). The grade 3 or 4 non-hematological toxicities included anorexia (18.9%) and nausea/vomiting (21.7%). CONCLUSION: Docetaxel and cisplatin combination chemotherapy showed promising anti-tumor activity and this was well tolerated as a first-line treatment for patients with recurrent or metastatic gastric cancer. Further large, randomized phase III studies are warranted.