A PILOT CLINICAL-TRIAL OF POSTOPERATIVE ADJUVANT INTRAPERITONEAL CISPLATIN, 5-FLUOROURACIL, 6S-LEUCOVORIN AND INTERFERON-ALPHA-2B IN PATIENTS WITH RESECTED GASTRIC-CANCER

Aims and Background: The study was performed to assess the toxicity and impact on relapse pattern of postoperative intraperitoneal cisplatin, 5-fluorouracil, leucovorin and interferon therapy as adjuvant treatment for gastric cancer patients who are at high risk for recurrence after potentially curative resection (T2 N1-2; T3-4 N any Mo). Patients and methods: Starting 14 to 21 days after potentially curative resection of primary gastric cancers, 22 patients were given intraperitoneal cisplatin, 60 mg/m(2); 5-fluorouracil, 1000 mg/m(2); 6S-leucovorin,250 mg/m(2); interferon alpha 2b, 10 MU/m(2); every other week for six times. Results: After a median follow-up of 24 months, 63 % of patients were alive and free of disease. Eight patients had recurred; five had an intraabdominal component, and 3 had extraabdominal failure. Toxicity was mild: no grade III-IV WHO toxicity was observed. Conclusions: Intraperitoneal cisplatin, 8-fluorouracil, 6S-leucovorin and interferon is a tolerable therapy in the postoperative setting for patients with resected gastric cancer. These data make this approach interesting for the development of new programs of adjuvant therapy of high-risk gastric cancer.