Intravesical bacillus Calmette-Guérin (Tokyo 172 strain) therapy for carcinoma in situ of the bladder.

To evaluate the clinical response to intravesical instillation therapy with bacillus Calmette-Guérin (BCG) Tokyo 172 strain for carcinoma in situ (CIS) of the bladder and subsequent patient prognosis, we reviewed data for 30 patients treated between 1985 and 1994. Median follow-up was 56 months. The CIS cases comprised two groups: primary (19 patients) and subsequent to development of a gross neoplasm (11 patients). Either 40 mg (n = 20) or 80 mg (n = 10) doses of BCG were instilled weekly for 8 weeks. This intravesical therapy resulted in apparent eradication of tumour cells in 25 of the 30 patients for a complete response (CR) rate of 83%, with no difference found between primary and secondary groups. Tumours later recurred in 6 of the 25 patients (24%) and disease progression was found in only 3 (12%). In contrast, progression occurred in 3 of 5 patients (60%) for which a complete response was not achieved with intravesical BCG therapy. The difference between these two groups was significant (p = 0.04). Total cystectomy was performed in 2 of 25 CR patients (8%) first and in 4 of the 5 unresponsive (80%), the statistical difference being highly significant (p = 0.003). The 5-year survival rate was 96% for the study subjects as a whole. In conclusion, CIS unresponsive to BCG therapy should be treated with immediate total cystectomy while cases demonstrating a complete response should be followed up for a long period.