Bacillus Calmette-Guerin therapy for high risk stage T1 superficial bladder cancer.

Numerous studies have shown bacillus Calmette-Guerin (BCG) to be an effective prophylactic and therapeutic agent for superficial transitional cell carcinoma of the bladder. The high grade stage T1 lesion treated by transurethral resection alone is reported to progress to muscle invasion in 30 to 50% of the patients. Therefore, some have recommended treatment with cystectomy. To evaluate BCG treatment of the stage T1 lesion we reviewed our results with a single or repeated 6-week course of the Armand-Frappier Pasteur strain BCG and compared them with those in the literature. We also compared these results with those of treatment of the stage TA lesion. We treated 30 stage T1 cancer patients who were described as at high risk based on the criteria of histology grade 3 in 24 and grade 2 in 6, carcinoma in situ present in 14 and positive urine cytology results 2 to 3 weeks after transurethral resection in 26. Followup ranged from 12 to 78 months, with a mean of 39 months. After a single 6-week course of BCG 14 patients (47%) had negative cytology and biopsy findings at 6 months. Also, 6 patients had conversion to negative cytology and biopsy results after a second 6-week course of treatment, for an over-all complete response rate of 66%. After the initial course of BCG 4 patients had progression to cystectomy: 1 for muscle invasion and 3 for a persistent stage T1 lesion. They had no evidence of disease 12 to 60 months postoperatively. One patient had progression to metastasis after a second course of BCG. Therefore, the over-all progression rate to cystectomy or metastasis was 17% (5 of 30 patients). All 5 patients were among the 16 who failed to achieve a complete response after the initial course of BCG. In conclusion, our experience and that of others demonstrate that BCG therapy is an effective initial treatment of stage T1 disease to prevent progression and recurrence, and to preserve bladder function. Close monitoring will identify those nonresponders who require surgical intervention.