A RANDOMIZED PROSPECTIVE-STUDY COMPARING INTRAVESICAL INSTILLATIONS OF MITOMYCIN-C, BCG-TICE, AND BCG-RIVM IN PTA-PT1 TUMORS AND PRIMARY-CARCINOMA IN-SITU OF THE URINARY-BLADDER

We compared intravesical instillations with mitomycin-C (MMC), Bacillu s Calmette-Guerin (BCG) Tice, and BCG-RIVM in patients with pTa-pT1 pa pillary carcinoma and primary carcinoma in situ (CIS) of the bladder. Nine instillations with MMC were given or 6 weekly instillations with BCG. Early recurrences were treated with additional instillations. For toxicity and efficacy 437 patients were evaluated with a median follo w-up of 32 months (range 12-56). Drug-induced and bacterial cystitis w ere the most frequent side-effects. The number and severity of side-ef fects (chi2 test) were comparable in both BCG groups, but were signifi cantly less in the MMC group for drug-induced cystitis (P = 0.009), ot her local side-effects (P = 0.004) and systemic side-effects (P < 0.00 1). The disease-free percentage (log-rank test) showed no significant difference for the three arms for papillary tumours (P = 0.08), nor th e CIS (P = 0.20), although for CIS numbers are small. Additional insti llations did not influence toxicity or efficacy.