Low dose pasteur bacillus Calmette-Guerin regimen in stage T1, grade 3 bladder cancer therapy

Purpose: We assessed the effectiveness of intravesical bacillus Calmette-Guerin (BCG) for high risk transitional cell carcinoma of the bladder. Materials and Methods: A total of 51 patients with stage T1, grade 3 disease was treated with weekly instillations of 75 mg. Pasteur strain BCG fur 6 weeks after transurethral resection for bladder cancer. An additional induction course was given to patients with relapse. Tumor-free patients followed a maintenance course with monthly instillations for 12 months. Results: After the initial induction course 37 of 51 patients (72.5%) remained tumor-free. A second induction course was necessary in 13 patients. After 1 or 2 induction courses 44 of 51 patients (86.3%) were tumor-free. The maintenance course was administered to 44 patients, with 41 remaining tumor-free. After a median followup of 33 months (range 3 to 63) 28 patients (54.9%) were disease-free, 12 (23.5%) had recurrent tumors and 7 (13.7%) had progression. The risk of treatment failure was significantly greater for solid than papillary tumors (p = 0.0006), recurrent than primary tumors (p = 0.0052) and coexisting carcinoma in situ (p = 0.0124) in multivariate analysis, and for early recurrence (p = 0.0001) in univariate analysis only. The drug was well tolerated with few side effects. Conclusions: Our data suggest that this low dose Pasteur BCC regimen is effective in the treatment of high risk superficial bladder cancer. Some tumor characteristics, such as solid appearance, coexisting carcinoma in situ, history of superficial transitional cell carcinoma and early relapse after the initial induction course, seem to be negative prognostic factors.