Purpose: We examined the efficacy of a 12-week prophylactic course of bacillus Calmette-Guerin (BCG) on superficial bladder cancer.
Materials and methods: From August 1992 until July 1994, 70 evaluable patients 41 to 80 years old (mean age 68.5) with high risk transitional cell carcinoma of the bladder were prospectively randomized to a 12-week prophylactic course of BCG (group 2) versus a traditional 6-week course (group 1). Mean followup was 28 months.
Results: A 70% tumor-free rate (21 patients) and mean interval of 12.9 months to recurrence were achieved in group 2 compared to 55% (22 patients) and 12.3 months, respectively, in group 1. Group 2 patients had an overall longer disease-free survival, although no statistical significance was achieved. A subgroup of patients with stage Ta cancer in whom at least 1 tumor was resected 12 month before treatment showed the most benefit from long-term prophylactic treatment in terms of disease-free survival. Side effects were only slightly more prominent in group 2, rendering the longer course fairly acceptable.
Conclusions: Our findings suggest a difference for better overall results with the 12-week course of BCG. However, a larger number of patients are needed to demonstrate a statistically significant difference between the 2 groups.