Long-term results of intravesical bacillus Calmette-Guerin therapy for stage T1 superficial bladder cancer

Objectives. To examine in a prospective study the incidence of recurrence a nd progression in patients with Stage T1 bladder carcinoma after complete t ransurethral resection of the bladder tumor and adjuvant immunotherapy with bacillus Calmette-Guerin (BCG). Methods. Between July 1987 and April 1999, 126 patients presenting to our c linic with a superficial urothelial carcinoma of the bladder (Stage pT1, gr ade 1-3) received adjuvant intravesical immunotherapy with BCG after comple te transurethral resection of the bladder tumor. In the case of recurrence of superficial tumor (pTa, pT1, or carcinoma in situ), patients received a second cycle of BCC. For muscle-invasive tumor progression (pT2, pT3, or pT 4), radical cystectomy was recommended. Six of the patients (5%) presented with Stage pT1,GI tumor, 74 (59%) with Stage pT1,G2 tumor, and 46 patients (36%) with Stage pT1,G3 tumor. Median follow-up was 53 months (range 3 to 1 44). Results. One hundred eight patients (86%) remained tumor-free with a retain ed bladder during the follow-up after one or two 6-week cycles of BCG. Twen ty-four patients (19%) had a recurrence of superficial tumor, 13 (10%) had muscle-invasive progression after the first BCG cycle, and an additional 4 (3%) had progression after the second BCG cycle. Six patients (5%) underwen t radical cystectomy, and 9 patients (7%) died as a result of tumor progres sion. The tumor-free survival rate of all patients was 89% (112 of 126). Conclusions. Adjuvant immunotherapy with BCG after complete transurethral r esection of the bladder tumor represents a highly effective primary treatme nt for Stage T1 carcinoma of the bladder. Even in Stage pT1,G3 tumor, immed iate radical cystectomy does not appear necessary. UROLOGY 55: 673-678, 200 0. (C) 2000, Elsevier Science inc.