Control group and maintenance treatment with Bacillus Calmette-Guerin for carcinoma in situ and/or high grade bladder tumors

Purpose: Intravesical instillations of bacillus Calmette-Guerin have demons trated satisfactory results in the treatment of vesical carcinoma in situ a nd high grade superficial bladder tumors. We designed a protocol to evaluat e the decrease in tumor recurrence with maintenance therapy. Materials and Methods: Between June 1989 and May 1995 an initial course of 6 intravesical instillations of Connaught strain bacillus Calmette-Guerin w as administered in patients with carcinoma in situ and/or high grade superf icial bladder tumors. Six months later 131 disease-free patients were rando mly assigned to a control group or a maintenance therapy group that receive d 6 instillations every 6 months (6 x 6) for a 2-year period. Results: Of the 126 evaluable patients at a mean followup of 79 months ther e were no significant differences in recurrence nor progression A total of 16 patients (26.2%) in the control and 10 (15.1%) in the maintenance group had superficial relapse at a mean of 24 and 20 months, respectively (p = 0. 07). Eight patients underwent radical cystectomy due to bladder contraction in 1, high grade superficial recurrence in 4 and disease progression in 3. Of the 65 patients on maintenance therapy 22 (33.85%) completed the planne d 2-year treatment. Conclusions: Six-month maintenance therapy in patients treated initially fo r carcinoma in situ and/or high grade superficial bladder tumors who are di sease-free at 6 months did not significantly decrease recurrence or progres sion.