[A randomized controlled study to compare 1-hexylcarbamoyl-5-fluorouracil (HCFU) and 1-(2-tetrahydrofuryl)-5-fluorouracil (Tegafur) for the prevention of post-operative recurrence of bladder cancer].

To evaluate the effect of 1-hexylcarbamoyl-5-fluorouracil (HCFU), a derivative of 5-fluorouracil (5-FU), in preventing postoperative recurrence of bladder cancer, a randomized controlled study with 1-(2-tetrahydrofuryl)-5-fluorouracil (Tegafur) as the reference standard was performed. HCFU was given orally 600 mg a day and Tegafur was given orally, 800 mg a day. The following results were obtained: Of 103 patients, 51 were given HCFU and 52 Tegafur, the non-recurrence rate in the group treated with HCFU was 70.8% after 1 year and 54.9% after 2 years of follow up, and that of the group treated with Tegafur was 56.5% and 46.2% respectively. The rate of non-recurrence in the HCFU group was significantly higher (p less than 0.01) than that of the Tegafur group during the period of follow up between 450 and 539 days. Of the 87 patients, who took the drugs for more than 90 days, the rate of non-recurrence in 43 patients receiving HCFU was 79.2% after 1 year and 60.4% after 2 years, compared to 62.5% and 50.0% respectively for 44 patients receiving Tegafur. The non-recurrence rate of the HCFU group was also significantly higher than that of the Tegafur group in the period between 450 and 539 days after operation (p less than 0.05). The incidence of side effects was 35.6% and 51.7% in HCFU and Tegafur patients, respectively. No significant difference of side effects was found between HCFU and Tegafur.