Combination chemotherapy with docetaxel and cisplatin for locally advancedand metastatic gastric cancer

Background: Poor treatment results obtained with palliative chemotherapy fo r advanced gastric cancer indicate the need for new effective and well-tole rated regimens. Patients and methods: Forty-three patients with locally advanced or metasta tic gastric cancer were enrolled in a phase II study to evaluate the effica cy and safety of combination chemotherapy with doxetacel 75 mg/m(2) and cis platin 75 mg/m(2) given every three weeks. Results: Thirty-nine patients were evaluable for response. Four achieved a complete response and twelve a partial response, for an overall response ra te of 37.2% (16 of 43 patients; 95% confidence interval (CI): 22.98-53.72). Median time to progression was 6.1 months and median overall survival 10.4 months. Forty-two percent of all patients were still alive at one year and twelve percent at two years. The major toxicity was leukopenia which reach ed grade 3-4 in 18.6% (n = 8) of the patients. However, no febrile neutrope nia occurred. Non-haematological toxicities were usually mild to moderate. Grade 3 toxicities included diarrhea (9% of the patients), nausea and vomit ing (7%), and alopecia (7%). Severe ototoxicity with or without peripheral neuropathy developed after completion of chemotherapy in two patients. Conclusions: These results suggest that the combination of docetaxel and ci splatin has moderate toxicity and is an effective regimen for the treatment of advanced gastric cancer, both with regard to response rate and survival .