Purpose: Our study was designed to compare the effects of preoperative irradiation and cystectomy to surgery alone in patients with transitional cell carcinoma of the bladder.
Materials and methods: A total of 140 patients with documented invasive bladder cancer or rapidly recurring superficial high grade tumors was randomized to receive 2,000 rad of pelvic irradiation followed by cystectomy within 1 week or surgery alone.
Results: The 5-year survival rate was 53% (95 confidence intervals 41 to 65%) in the surgery only group and 43% (95% confidence intervals 30 to 56%) in the irradiation plus surgery group. The p value for the log rank statistic comparing the survival distributions was 0.23.
Conclusions: Although this trial showed no benefit for preoperative irradiation and cystectomy, the confidence intervals were wide. This finding does not exclude the possibility of a favorable effect of radiation in a subset of patients with high stage tumors. Overall, however, the dominant effect of distant disease as a cause of treatment failure diminishes any potential impact of radiation on results.