Mitomycin C (MMC) with weekly 24-hour infusions of high-dose 5-fluorouracil and leucovorin in patients with advanced gastric cancer

Background: We have reported a 33% response rate with 5-fluorouracil/leucovorin (5-FU/LV) treatment along with a median survival of 7 months in patients with advanced gastric cancer. Subsequently, mitomycin C (MMC) became our target agent for the combination because of its activity towards gastric cancer. Methods: From May 1998 to December 2000, a total of 37 chemo-naive patients with advanced gastric cancer were included. There were 20 men and 17 women with a median age of 58 (range, 21-73) years. The regimen consisted of 2600 mg/m² 5-FU and 100 mg/m² LV admixed in an outpatient infusion pump administered for 24 hours every week for 6 weeks, followed by a 2-week break; then 10 mg/m² MMC was given once every 8 weeks. The treatment continued until disease progression or unacceptable toxicity was noted, or the patient refused. Results: In total, 404 treatments of 5-FU/LV were given. The mean number of treatments was 10 (range, 1 to 24). The intent to treat response rate was 40.5% (15/37) with 5.4% (2/37) showing a complete response. The median time to disease progression was 4.5 months. The median survival time was 8.0 months. All of the patients were evaluated for toxicity. Less than 10% of the patients developed grade III/IV toxicity. Conclusion: MMC with weekly 24-hour infusions of high-dose 5-FU and LV produced moderate activity in patients with advanced gastric cancer, and patients showed acceptable toxicity.