Hyperfractionated radiotherapy of bladder cancer. A ten-year follow-up of a randomized clinical trial.

One hundred and sixty-eight patients with invasive bladder cancer, T2-T4, were randomized to one of two treatments; hyperfractionation with 1 Gy 3 times a day to a total of 84 Gy or conventional treatment 2 Gy once a day to a total of 64 Gy. Both treatments were given over 8 weeks with a rest interval of 2 weeks in the middle of the treatment period. The present report included all patients after a follow-up period of at least 10 years. The survival benefit from hyperfractionation previously reported after 5 years is still evident after 10 years. The effect was detectable in all three subsets (T2, T3 and T4) and in the pooled data. However, it only reached statistical significance in the T3 subset and in the total pooled data set. Local control was also assessed by cystoscopy and cytology on bladder washouts. An improvement in local control was seen at all follow-up intervals and at all times out to 10 years but the differences were not statistically significant due to the falling number of patients available for assessment. Complications in the bowel requiring surgical treatment were more common in the hyperfractionated group but the difference was not significant since this group consisted of a greater number of patients alive and therefore at risk. This trial showed that the benefit of the hyperfractionated schedule persisted over a 10-year follow-up period, both for local control and survival.