BACKGROUND: A randomized prospective trial was performed to determine whether long-term oral UFT (a 1:4 mixture of tegafur and uracil) (Taiho Pharmaceutical Co., Tokyo, Japan) therapy was effective in preventing the intravesical recurrence of superficial bladder cancer. METHODS: A total of 112 patients with newly diagnosed superficial transitional cell carcinoma of bladder (Ta, T1 and G1 or G2) were randomized into a UFT-treated group (300-400 mg/d for 2 years) and a control group. RESULTS: After a median follow-up period of 24.5 months, the recurrence rate was 25.7% for the UFT group and 43.3% for the control group (P = 0.015, log-rank test). Side effects of UFT administration were acceptably low. CONCLUSIONS: These results suggest that long-term UFT administration after transurethral resection is effective in preventing the recurrence of superficial bladder cancer.
RCT Entities:
BACKGROUND: A randomized prospective trial was performed to determine whether long-term oral UFT (a 1:4 mixture of tegafur and uracil) (Taiho Pharmaceutical Co., Tokyo, Japan) therapy was effective in preventing the intravesical recurrence of superficial bladder cancer. METHODS: A total of 112 patients with newly diagnosed superficial transitional cell carcinoma of bladder (Ta, T1 and G1 or G2) were randomized into a UFT-treated group (300-400 mg/d for 2 years) and a control group. RESULTS: After a median follow-up period of 24.5 months, the recurrence rate was 25.7% for the UFT group and 43.3% for the control group (P = 0.015, log-rank test). Side effects of UFT administration were acceptably low. CONCLUSIONS: These results suggest that long-term UFT administration after transurethral resection is effective in preventing the recurrence of superficial bladder cancer.