Weekly 24-Hour Infusion of High-Dose 5-Fluorouracil plus Folinic Acid in Combination with Mitomycin C for the Treatment of Advanced Gastric Cancer

Abstract

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 combination with folinic acid plus mitomycin C in patients with advanced gastric cancer. Patients and Methods: Chemonaive patients with locally advanced inoperable, recurrent or metastatic gastric cancer were treated with 15 mg/m² i.v. mitomycin C as bolus on day 1 of a 7-week cycle followed by a 2-hour infusion of folinic acid (500 mg/m²) and a 24-hour infusion of 5-FU (2,600 mg/m²) given on days 1, 8, 15, 22, 29, and 36 as outpatient treatment. Results: Thirty evaluable patients (median age 58 years and median ECOG performance status 1) received 1–4 cycles (median 3). 53% of the patients had liver metastases. Treatment-related toxicity was low with 10% of patients experiencing diarrhea ≥grade 3, 3% mucositis grade 3 and 3% nausea grade 3 (CTC). Hematological toxicity was mild with 13% thrombopenia grade 3 and no leukopenia grade 4. Eleven patients achieved a partial remission (major response rate 37%; 95% confidence interval 22–53%). Median time to progression was 5 months and median overall survival time was 7 months. Conclusion: This regimen is a well-tolerated outpatient treatment for patients with advanced gastric cancer with efficacy being comparable to other chemotherapy protocols.