Purpose: The purpose of this study was to determine the efficacy and toxicity of uracil/tegafur (UFT) plus oral leucovorin (LV) and mitomycin C as salvage chemotherapy for heavily pretreated patients with metastatic colorectal cancer.
Methods: A total of 44 patients were treated with i.v. mitomycin C (6 mg/m(2) on day 1) and oral UFT (350 mg/m(2)) plus LV (90 mg), both divided in 3 daily doses from day 1 to day 14 every 3 weeks. All patients had failed prior first-line and second- line treatment with oxaliplatin, bevacizumab, irinotecan, cetuximab and 5-fluorouracil (5-FU). Forty -three patients were evaluable for the response.
Results: The overall response rate (intent-to-treat) was 9.3% and disease stabilization was achieved in 25.7% of the patients. Median time to progression (TTP) was 5 months (range 2-13) and median overall survival (OS) 7.5 months (range 4-16). Fatigue and myelosuppression were the most frequent side effects. The most common nonhematological toxicities consisted of mild and reversible nausea and diarrhea. Severe symptoms were only occasionally seen.
Conclusion: These data show that the combination of mitomycin C/UFT/LV provides an acceptable and safe therapeutic option in extensively pretreated metastatic colorectal cancer.