TREATMENT OF ADVANCED BLADDER-CANCER WITH COMBINED PREOPERATIVE IRRADIATION AND RADICAL CYSTECTOMY VERSUS RADICAL CYSTECTOMY ALONE - A PHASE-III INTERGROUP STUDY

Purpose: Our study was designed to compare the effects of preoperative irradiation and cystectomy to surgery alone in patients with transiti onal cell carcinoma of the bladder. Materials and Methods: A total of 140 patients with documented invasive bladder cancer or rapidly recurr ing 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 interv als 41 to 65%) in the surgery only group and 43% (95% confidence inter vals 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 i rradiation and cystectomy, the confidence intervals were wide. This fi nding does not exclude the possibility of a favorable effect of radiat ion 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.