Chemoimmunotherapy protocol in patients with advanced gastric cancer

Abstract

We tested in a prospective phase II study a chemo-immuno therapy protocol in advanced gastric cancer patients. The regimen consisted of Cisplatin 50 mg/m(2) D3, 5-FU 375 mg/m(2) D1-3, Folinic Acid 20 mg/m(2) D1-3, IFN-alpha 2b 3 Mio U sc. D1-3, every 28d; and IFN-alpha 2b 3 Mio U sc. 3 times weekly between the cycles. Twentyfive patients were included (20 males, 5 females). Mean age was 54,3 yr (25-75). Five presented with locally advanced disease and 20 had metastatic disease. Response rate was 40% (1 CR, 7 PR). Median overall survival was 9+/-3 months (95% CI 7-10 months). The toxicity profile of this regimen was: G I-II Fever: 14 patients, G II Neutropenia: 3 patients, G I Renal toxicity: 2 patients. We conclude that, this regimen is well tolerated on an outpatient basis, and effective in advanced gastric cancer patients.