Intravesical therapy comparing BCG, adriamycin, and thiotepa in 200 patients with superficial bladder cancer: a randomized prospective study.

: This report presents the second interim analysis of data from a randomized prospective trial that compares the prophylactic effect of 15 intravesical instillations of 50 mg Doxorubicin (ADM), 50 mg of Thiotepa (TTPA), or 150 mg of Bacillus Calmette-Guerin (BCG) against recurrence and progression of superficial transitional cell bladder cancer. Of 202 enrolled patients, 176 patients are currently evaluable after a mean follow-up of 3 years (range, 3-97 months). The number of patients with recurrence was significantly lower in the BCG group (9/67) than in the ADM group (23/53, p = 0.002) or the TTPA group (20/56, p = 0.003). The overall recurrence index per 100 patient-months was also significantly lower for the BCG group (BCG vs. ADM, p = 0.07; BCG vs. TTPA, p = 0.001; TTPA vs. ADM, not significant). BCG was superior in preventing recurrence and progression of high risk tumors (T1, G2-3, multiple growth, and tumors associated with carcinoma in situ). The recurrence in this group of high risk tumors was for ADM treated patients 12/17, for TTPA treated patients 10/17 and for BCG treated patients 5/23 (BCG vs. ADM, p = 0.002; BCG vs. TTPA, p = 0.016; TTPA vs. ADM, not significant). Toxicity of intravesical BCG was higher than that of the other drugs, but not limiting the treatment. Bladder irritability occurred in 42% of the patients, granulomatous cystitis in 16.4%, and bladder contraction in 1.5% of the patients. Two patients of the ADM group (2/53 = 3.8%) underwent radical cystectomy for local urothelial progression. One patient (1.9%) in the same group died of distant metastases. The preliminary results suggest that BCG is significantly superior to the chemotherapeutic agents ADM and TTPA when used as an adjuvant intravesical therapy in superficial bladder cancer.