Summary of effect of intravesical bacillus Calmette-Guerin (BCG) on carcinoma in situ of the bladder (by Harry W. Herr, Carl M. Pinsky, Willet F. Whitmore, Jr, Herbert F. Oettgen, and Myron R. Melamed)
Carcinoma in Situ
Urinary Bladder Neoplasms
Objective: To evaluate the response of carcinoma in situ (CIS) of the bladder to bacillus Calmette-Guerin (BCG) therapy as an adjunct to surgery in a randomized clinical trial. Patients and Methods: Between 1978 and 1980, 69 patients with polychronotopic papillary superficial bladder tumors were randomized to receive either transurethral resection (TUR) alone (35 patients) or TUR plus BCG (34 patients). BCG (Frappier strain) was given both intravesically (120 mg in 50 mL saline) and percutaneously (5 x 107 viable organisms), weekly for 6 weeks, beginning 2 to 4 weeks after TUR of all papillary tumors. None of the patients received a second course of BCG. Of the 69 patients, 41 (59%) had multiple (>2) areas of CIS documented by positive biopsy and voided urine cytology results-17 (50%) in the TUR + BCG group and 24 (69%) in TUR (control) group. Response of TIS to BCG therapy was evaluated 6 months after entry on the protocol. A complete response (CR) was defined as a normal bladder at cystoscopy, negative biopsy results in areas of CIS, negative voided urine cytology results, and absence of CIS-related symptoms (ie, urinary frequency, urgency, burning). Biopsies or urine cytology that tested positive were regarded as incomplete or no response. Results: The median period of follow-up was 18 months (range, 12 to 30 months). CR was achieved in 11 (66%) of the BCG-treated patients for a median duration of 18 months (range, 12 to 30 months) versus only 2 (8%) of the patients in the control group (P = 0.01). Three patients had a cystectomy for tumor progression at 12, 15, and 18 months, respectively, after a CR to BCG lasting only 6 (1 patient) or 9 (2 patients) months (tumor confined to prostatic urethra and ducts in 2 patients). Twelve patients in the control group had a cystectomy for a muscle-invasive tumor. Conclusion: BCG therapy produced CRs in more patients with diffuse CIS of the bladder than TUR alone. Disease-free intervals lasted in some cases for more than 2 years.