A PHASE-II STUDY OF 5-FLUOROURACIL, LEUCOVORIN AND CISPLATIN (FLP) FOR METASTATIC GASTRIC-CANCER

The modulation of 5-fluorouracil (5-FU) with folinic acid (leucovorin, LV) is more efficacious than 5-FU alone in the treatment of metastati c colorectal cancer, and the combination of S-FU with cisplatin is cur rently one of the most active regimens in advanced gastric cancer. A p hase II study was therefore conducted to test the efficacy and toxicit y of the combination of 5-FU, LV and cisplatin (FLP) in metastatic gas tric cancer. 28 patients entered the study. Metastatic sites were obse rved in the liver (in 21 patients), the peritoneum (in 8), the lymph n odes (in 7) or the bones (in 1) and a local recurrence was noted in 4 cases. The performance status (using World Health Organisation criteri a) was 0 for 13 patients and 1 or 2 for the others. Cycles of treatmen t were administered every 28 days and consisted of LV 200 mg/m(2)/day for 5 days followed by 5-FU 400 mg/m(2)/day for 5 days with cisplatin 100 mg/m(2) on day 2. The response rate for the 27 evaluable patients was 51.8% (95% confidence interval (CI), 33-70.6%). There were four co mplete responses (14.8%) and 10 partial responses (37%). Median surviv al was 11 months and 4 patients were alive at 2 years. Both response r ate and survival were better for patients with a good performance stat us. The overall toxicity was very low, except for 1 patient who died o f dehydration and cardiac failure. In conclusion, the FLP protocol was effective and well tolerated in patients with metastatic gastric canc er. Copyright (C) 1996 Published by Elsevier Science Ltd