Randomized clinical trial on chemoprophylaxis of recurrence in cases of superficial bladder cancer.

Several postoperative adjuvant therapeutic modalities have been adopted in attempts to reduce the recurrence rate of superficial bladder cancer. However, no definite conclusions on the effectiveness of intravesical chemoprophylaxis have been reached. A randomized clinical study on intravesical chemoprophylaxis was conducted by the Japanese Urological Cancer Research Group for Adriamycin to compare the recurrence rates among 575 patients with superficial transitional cell carcinoma of the urinary bladder. Group A received 30 mg/30 ml Adriamycin; group B received 20 mg/40 ml Adriamycin; group C received 20 mg/40 ml mitomycin C, and group D, no treatment (for control). Instillation was performed twice a week for 4 weeks after surgery. The postoperative observation period was 18 months. The overall recurrence rate in group D was 61.5%, which was statistically higher than in the other groups. The Adriamycin and Mitomycin C groups showed recurrence rates of 43%-48% and 57%, respectively. Intravesical Adriamycin and Mitomycin C appeared to be effective in the prophylaxis of recurrence during this observation period. The main side-effect was cystitis syndrome, which was observed in 10%-20% of the patients. There were no life-threatening adverse effects in this series of patients.