Weekly 24-hour infusion of high-dose 5-fluorouvacil plus folinic acid in combination with mitomycin C for the treatment of advanced gastric cancer

Purpose: This study was performed to investigate the activity and safety of high dose 5-fluorouracil (5-FU) given as a weekly 24-hour infusion in comb ination with folinic acid plus mitomycin C in patients with advanced gastri c cancer. Patients and Methods: Chemonaive patients with locally advanced i noperable, recurrent or metastatic gastric cancer were treated with 15 mg/m (2) i.v, mitomycin C as bolus on day 1 of a 7-week cycle followed by a 2-ho ur infusion of folinic acid (500 mg/m(2)) and a 24-hour infusion of 5-FU (2 ,600 mg/m(2)) given on days 1, 8, 15, 22, 29, and 36 as outpatient treatmen t. Results: Thirty evaluable patients (median age 58 years and median ECOG performance status 1) received 1-4 cycles (median 3). 53% of the patients h ad liver metastases. Treatment-related toxicity was low with 10% of patient s experiencing diarrhea greater than or equal to grade 3, 3% mucositis grad e 3 and 3% nausea grade 3 (CTC). Hematological toxicity was mild with 13% t hrombopenia grade 3 and no leukopenia grade 4. Eleven patients achieved a p artial remission (major response rate 37%; 95% confidence interval 22-53%). Median time to progression was 5 months and median overall survival time w as 7 months. Conclusion: This regimen is a well-tolerated outpatient treatm ent for patients with advanced gastric cancer with efficacy being comparabl e to other chemotherapy protocols. Copyright (C) 2000 S. Karger AG, Basel.