Postoperative adjuvant chemotherapy with mitomycin C and UFT for rectal cancer.

To evaluate the significance of postoperative adjuvant chemotherapy using mitomycin C (MMC) and UFT (tegafur and uracil) in combination, the Japanese Foundation for Multidisciplinary Treatment of Cancer conducted a prospective randomized controlled trial with 834 patients who had undergone curative resection for rectal cancer (T3 or T4 tumors and/or N1, N2, or N3 disease). The patients were randomly allocated to a treatment group (MMC/UFT, 416 patients) and a control group (surgery only, 418 patients). For patients in the treatment group, 20 mg of MMC was sprinkled on the operating field upon completion of surgery. MMC was intravenously injected at 6 mg/m2 on day 7, and then each month after surgery for 6 months. UFT was administered orally at 400 mg/day for 1 year. Although no difference was observed in the 5-year survival rate between the two groups, the 5-year disease-free survival rate in the MMC/UFT group was 69.1%, which was significantly higher than in the control group (59.3%, P = .005). The 5-year cumulative local recurrence rate was significantly lower in the MMC/UFT group (11.6%) than in the control group (19.0%) (P = .0071). We conclude that the adjuvant use of long-term oral UFT and intermittent intravenous MMC improves the disease-free survival rate of patients with curatively resected rectal cancer.

RCT Entities:   Population Interventions Outcomes