RESULTS OF A RANDOMIZED PHASE-III TRIAL OF SEQUENTIAL, INTRAVESICAL THERAPY WITH MITOMYCIN-C AND BACILLUS-CALMETTE-GUERIN VERSUS MITOMYCIN-C ALONE IN PATIENTS WITH SUPERFICIAL BLADDER-CANCER

Purpose: We study toxicity and efficacy of sequential intravesical the rapy with mitomycin C and bacillus Calmette-Guerin (BCG) in patients w ith intermediate or high risk superficial bladder cancer compared to t he use of intravesical mitomycin C alone. Materials and Methods: Patie nts with intermediate and high risk papillary superficial bladder canc er and carcinoma in situ were randomized after transurethral resection between 4 weekly instillations with 40 mg. mitomycin C followed by 6 weekly instillations with BCG (group 1, 90 patients) or 10 weekly inst illations with mitomycin C (group 2, 92 patients). Results: The freque ncy of bacterial and chemical cystitis, and other local side effects w as similar in both groups. Allergic reactions, including skin rash, we re more frequent in the mitomycin C only group (12 of 92 patients vers us 5 of 90, p = 0.08), and other systemic side effects were more frequ ent in the sequential group (16 of 90 versus 8 of 92, p = 0.07). After a median followup of 32 months the number of recurrences (sequential 35 of 90 patients versus mitomycin C only 42 of 92, p = 0.36) and prog ression (5 of 90 versus 4 of 92 respectively, p 0.70) were similar in both groups. Conclusions: We did not find any major differences in tox icity or treatment; efficacy with intravesical mitomycin C and the seq uential use of BCG or mitomycin C for intermediate and high risk super ficial papillary bladder cancer.