Long-term followup analysis of a randomized prospective study comparing intravesical electromotive mitomycin-C, passive diffusion mitomycin-C and bacillus Calmette-Guerin in patients with carcinoma in situ of the bladder.

5078 Background: This randomized trial was designed to assess the long-term efficacy of intravesical passive diffusion mitomycin-C (PD/MMC), electromotive/mitomycin-C (EMDA/MMC) and bacillus Calmette-Guerin (BCG) in carcinoma in situ (Tis) of the urinary bladder. Methods: 108 patients with Tis of the bladder were randomly assigned to: 40 mg PD/MMC for 60 min (n=36); 40 mg EMDA/MMC with 20 mA electric current for 30 min (n=36); or 81 mg BCG for 120 min (n=36). All patients were scheduled for 6 weekly treatments. Non-responders received another 6 weekly treatments while responders received 10 monthly treatments. Analyses were done by intention to treat. Results: The complete response rates at 3 months for the PD/MMC, EMDA/MMC and BCG groups were 28%, 53% and 56%, respectively (p=0.0361). At 6 months the corresponding rates rose to 31%, 58% and 64% (p=0.0123). After a median follow-up of 82.5 months (range 17.8–148.8) 32/108 patients (29.6%) were disease-free. They included 7 (19.4%) in the PD/MMC group, 12 ...