Low dose bacillus Calmette-Guerin for carcinoma in situ of the bladder: long-term results.

PURPOSE: Bacillus Calmette-Guerin (BCG) is standard treatment for carcinoma in situ of the bladder. However, its long-term effectiveness is still debated.
MATERIALS AND METHODS: From January 1987 to January 1995, 70 consecutive patients with primary or secondary carcinoma in situ with or without concomitant solitary or multifocal papillary tumor were treated with weekly instillations of 75 mg. Pasteur strain BCG for 6 weeks after histological diagnosis. An additional induction course was given to patients with relapse. Tumor-free patients were given a maintenance course of monthly instillations for 12 months.
RESULTS: At the end of induction course 1, 56 of the 70 patients (80%) were tumor-free. Of 14 patients given induction course 2, 9 had a complete response (64.2%). A total of 65 patients (92.8%) were disease-free after 1 or 2 courses and given the maintenance course. Median followup for disease-free patients was 74 months (range 17 to 134). Subsequently 50 patients (71.4%) were disease-free, 12 (17.1%) had recurrence and 8 (11.4%) had progression. Mean time was 18 months (range 6 to 69) to treatment failure and 13 months (range 7 to 53) to progression. Of the patients 1 died of disease and 10 of other causes. Crude survival was 84.2%, disease specific mortality 1.4% and nondisease specific mortality 14.2%. The risk of treatment failure was significantly greater for carcinoma in situ associated with stage T1 papillary tumor (p = 0.0001) or severe dysplasia (p = 0.0005), and the risk of disease progression was significantly greater for carcinoma in situ associated with stage T1 papillary tumor (p = 0.0001). The drug was well tolerated with few side effects.
CONCLUSIONS: Intravesical BCG is the best available conservative therapy for patients with carcinoma in situ of the bladder. Low dose BCG is similarly effective, with a lower incidence of side effects and long lasting positive outcome.