RESULTS AT 43 MONTHS FOLLOW-UP OF A DOUBLE-BLIND, RANDOMIZED, PROSPECTIVE CLINICAL-TRIAL USING INTRAVESICAL INTERFERON-ALPHA-2B IN THE PROPHYLAXIS OF STAGE PT1 TRANSITIONAL-CELL CARCINOMA OF THE BLADDER

Objectives. To assess the intravesical efficacy of 60 million units of interferon (IFN) alpha-2b in preventing recurrences of Stage pT1 tran sitional cell carcinoma of the bladder, as well as to assess its local and systemic toxicity. Methods. A total of 90 patients were included in a double-blind, randomized, prospective clinical trial and divided into two groups of 45 patients. After complete transurethral resection , 60 million units IFN alpha-2b was instilled in one group; in the oth er, double-distilled water was used. The therapeutic regimen consisted of weekly instillation for 12 weeks, followed by once-monthly instill ation until patients had completed 1 year of treatment. Results. Only 78 patients were evaluable. After 12 months of follow-up, the relapse rate was 28.2% (11 of 39) for the IFN group and 35.8% (14 of 39) for t he control group (P = NS). After 43 months (range 9 to 67), relapse ra tes were 53.8% (21 of 39) and 51.2% (20 of 39), respectively (P = NS). Progression, mortality, and local or systemic toxicity were similar i n both groups. Flulike syndrome was not reported. Conclusions. At the dose used in this study, IFN alpha-2b proved ineffective in the prophy laxis of Stage pT1 transitional cell carcinoma of the bladder compared with a control group, Toxicity was virtually absent. Copyright 1997 b y Elsevier Science Inc.