Multicenter randomized prospective study of adjuvant chemotherapy with UFT and mitomycin C in advanced colorectal cancer.

BACKGROUND: A randomized prospective trial was performed to determine the efficacy of preoperative and postoperative adjuvant oral UFT, administered with mitomycin C (MMC) after resection for advanced colorectal cancer. MATERIALS AND METHODS: A total of 126 patients were entered in the study. The patients received UFT (400 mg daily) administered orally for seven days prior to surgery and were randomly assigned to two groups immediately following surgery. Group A received MMC postoperatively; Group B received the same regimen as Group A, plus administration of UFT orally at a dose of 400 mg daily for one year. RESULTS: The survival results revealed no significant difference between groups A and B. In patients with nuclear DNA aneuploid tumors, the hematogenous recurrence rate after curative surgery was lower in Group B than in Group A (P = 0.0656). CONCLUSIONS: Preoperative and postoperative adjuvant oral UFT, administered with MMC after curative resection, may be effective in preventing hematogenous recurrence in colorectal cancer patients with nuclear DNA aneuploidy tumors.