Intravesical Bacillus Calmette-Guérin with the Danish strain for treatment of carcinoma in situ of the bladder.

Abstract

We report our experience of the treatment of carcinoma in situ (CIS) using intravesical therapy with the Danish Bacillus Calmette-Guérin (BCG) strain 331 (SSI). Forty-two patients received treatment, 11 had primary and 31 secondary CIS. The median follow-up period was 26 months (range 3-68). Patients received 6 weekly instillations (1 course) and non-responders an additional 6 instillations at 2-week intervals (2 courses). The complete response rate was 59% for 1-course patients, 33% for the 2-course patients and 68% for the entire series. Patients were considered treatment failures if they suffered progression to invasive cancer, metastasis or died from transitional cell carcinoma. BCG treatment was more effective in primary than in secondary CIS, with a complete response rate of 80% versus 65% and with no failures versus 35%. Patients with persistent CIS after the first course of BCG had a greater risk of failure than responders: 50% versus 17%. Patients with persistent CIS after the second course had a 75% failure rate. This suggests that cystectomy should be considered for non-responders following a 6-week course and recommended to those not responding to 2 courses. Ten patients had CIS in the prostatic urethra. All responded to BCG treatment; 2 suffered from recurrent CIS 1 associated with invasive urethral tumour. The incidence and severity of side effects were similar to those reported with other strains of BCG. One patient with primary CIS failed to complete the treatment owing to "BCG-itis".