Treatment of advanced bladder cancer with combined preoperative irradiation and radical cystectomy versus radical cystectomy alone: a phase III intergroup study.

Abstract

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. 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. 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. 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.