LOW-DOSE PASTEUR BACILLUS-CALMETTE-GUERIN REGIMEN IN STAGE T1, GRADE-3 BLADDER-CANCER THERAPY

Purpose: We assessed the effectiveness of intravesical bacillus Calmet te-Guerin (BCG) for high risk transitional cell carcinoma of the bladd er. Materials and Methods: A total of 51 patients with stage T1, grade 3 disease was treated with weekly instillations of 75 mg. Pasteur str ain BCG fur 6 weeks after transurethral resection for bladder cancer. An additional induction course was given to patients with relapse. Tum or-free patients followed a maintenance course with monthly instillati ons for 12 months. Results: After the initial induction course 37 of 5 1 patients (72.5%) remained tumor-free. A second induction course was necessary in 13 patients. After 1 or 2 induction courses 44 of 51 pati ents (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 papillar y tumors (p = 0.0006), recurrent than primary tumors (p = 0.0052) and coexisting carcinoma in situ (p = 0.0124) in multivariate analysis, an d for early recurrence (p = 0.0001) in univariate analysis only. The d rug was well tolerated with few side effects. Conclusions: Our data su ggest that this low dose Pasteur BCC regimen is effective in the treat ment of high risk superficial bladder cancer. Some tumor characteristi cs, such as solid appearance, coexisting carcinoma in situ, history of superficial transitional cell carcinoma and early relapse after the i nitial induction course, seem to be negative prognostic factors.