Weekly paclitaxel in combination with doxifluridine for peritoneally disseminated gastric cancer with malignant ascites.

Background: The efficacy of systemic chemotherapy for peritoneal dissemination of gastric cancer remains unclear. The efficacy of weekly paclitaxel in combination with doxifluridine (5'-DFUR) in gastric cancer patients with malignant ascites was evaluated. Patients and Methods: Patients with histologically confirmed gastric cancer with ascites were eligible. The treatment consisted of paclitaxel intravenously (i.v.) administered at 80 mg/m(2) on days 1, 8 and 15 every 4 weeks, and doxifluridine administered orally at 533 mg/m2 on days 15 every week. The response rate for patients with ascites was determined based on the Japanese Classification of Gastric Carcinoma. Also, the concentration of paclitaxel in the ascites was measured. Results: Twenty-four patients were investigated. The response rate (RR) was 41.7%, including complete remission (CR) and partial remission (PR) in 4 and 6 patients, respectively. The concentration of paclitaxel in the ascites was maintained between 0.01 mu M and 0.05 mu M until 72 hours. The median overall survival (OS) was 215 days, and 1-year survival rate was 29.2%. No severe toxicity was noted. Conclusion: Weekly paclitaxel in combination with doxifluridine is effective for gastric cancer patients with malignant ascites with an acceptable toxicity profile.