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Jarvinen R et al. - In a study to compare the long-term benefit of bacillus Calmette-Guérin (BCG) and mitomycin C (MMC) maintenance therapy in pts with recurrent bladder carcinoma, it was found that BCG instillation therapy significantly reduces recurrence in frequently recurrent bladder cancer. It is difficult to demonstrate its impact on overall survival because of the low progression rate, limited efficacy on progression, and high proportion of competing causes of death.
Methods- 89 pts with frequently recurrent TaT1 disease without carcinoma in situ (CIS) were eligible.
- Pts were enrolled in the prospective FinnBladder I study between 1984 and 1987 and randomised to receive BCG or MMC.
- Both regimens involved 5 wkly instillations, followed by monthly instillations for 2 yr.
- Because of alkalinising the urine and adjusting the dose to bladder capacity, the average concentration of MMC was low: 30–40 mg in 150–200 ml of phosphate buffer.
- Overall median follow-up time was 8.5 yr, whereas median follow-up time of pts who were still alive was 19.4 yr.
- Primary endpoints were time to first recurrence and overall mortality; secondary endpoints were progression and disease-specific mortality.
- 36 of 45 pts (80.0%) in the MMC group experienced recurrence in contrast to 26 of 44 pts (59.1%) in the BCG group.
- This finding was reflected in significantly lower cumulative incidence estimates in the BCG group.
- There was a weak trend for fewer progressions and cancer-specific deaths in the cumulative incidence analysis, as 4 vs 10 pts progressed and 4 vs 9 pts died from the disease in the BCG group vs the MMC group, respectively.
- No difference existed in the overall mortality.
- The study population was too small for conclusive evidence about progression or survival.
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