A prospective randomized study of preoperative irradiation with cystectomy or cystectomy alone for invasive bladder carcinoma.

Prognosis was studied in 44 patients with urothelial bladder tumors, WHO grades 2 or 3, invading the lamina propria or the muscular coat, without signs of distant metastases. The patients were preoperatively randomized into two groups according to treatment: total cystectomy with or without preoperative irradiation. The 3- and 5-year survival rates were 81 and 61%, respectively, in 22 patients not receiving preoperative irradiation. 22 patients preoperatively irradiated had 3- and 5-year survival rates of 81 and 75%, respectively. Individuals who were tumor-free at cystectomy after preoperative irradiation had an excellent prognosis and tumor eradication was achieved in 80% when a cumulative radiation effect (CRE) above 1,400 reu was administered. Only 1 of 10 patients who received a CRE above 1,400 reu died from bladder tumor. This might indicate that preoperative irradiation improves the survival rate providing the CRE exceeds 1,400 reu. The presence of residual tumor after transurethral resection, aimed at resecting the tumor completely, seems difficult to evaluate since the surgeon was mistaken in believing the excision to be radical in more than 50% of the cases. The risk of error was especially high when the tumor infiltrated the muscular wall of the bladder.

RCT Entities:   Population Interventions Outcomes