A multicentre phase II study of docetaxel plus cisplatin for the treatment of advanced gastric cancer.

BACKGROUND: The optimum regimen for advanced gastric cancer requires definition. This multicentre phase II study evaluated docetaxel-cisplatin combination in advanced gastric cancer. METHODS: Chemotherapy-naive patients with locally advanced or metastatic disease received docetaxel plus cisplatin (75/75 mg/m(2)) every 21 days for up to 9 cycles. Endpoints included tumour response, time to progression, overall survival and toxicity. RESULTS: Of 113 patients recruited, 88 were completely evaluable. The median age was 58 years, and most patients had metastatic disease. The overall response rate was 29.6%. Five patients (5.7%) achieved a complete response and 21 patients (23.9%) had a partial response. Tumour control, including stable disease, was achieved in 57 patients (64.8%). The median time to progression and median overall survival time was 4.8 and 8.7 months, respectively. The major toxicity was haematological: 37.5% of patients experienced grade 3-4 neutropenia, whereas febrile neutropenia was observed in only 2% of patients. CONCLUSION: Docetaxel-cisplatin was active with a predictable and manageable toxicity profile.