Bacillus Calmette-Guérin versus mitomycin intravesical therapy in superficial bladder cancer: Results of randomized trial after 21 months of follow-up

The results of a randomized, prospective, two-arm study are reported in which treatment with bacillus Calmette-Guérin (BCG) was compared with mitomycin therapy in patients with primary or recurrent superficial bladder tumors, including carcinoma in situ. Mean follow-up time was 21.25 months. After complete transurethral resection of all visible tumors, the following therapeutic regimens were given: in group 1, BCG (5 × 108 bacilli in 50 mL saline) was instilled once a week for six consecutive weeks; in group 2, mitomycin (30 mg in 50 mL saline) was instilled once a week for one month (weeks 1 to 4) and thereafter once a month for a total of six months. The incidence of side effects in 338 patients and the tumor recurrence rate in 325 patients are presented. Local side effects of treatment, classified as drug-induced (chemical) cystitis, were observed in 30 of 165 treated patients (18 %) in group 1 and in 36 of 173 treated patients (21 %) in group 2. Bacterial cystitis occurred in 43 (26 %) and 35 (20 %) of the patients in each group, respectively. Systemic side effects were observed in 10 patients (6 %) in group 1 and in 5 patients (3 % ) in group 2. Treatment was stopped due to systemic side effects in 5 patients (3 %) in group 1 and in none in group 2. Of the patients treated with BCG (n = 158), disease recurred in 66 patients (42 %), whereas, of those patients who received mitomycin (n = 167), 60 (36%) had disease recurrence. The recurrence rate is 0.28 for group 1 and 0.24 for group 2, which was not significant (P = 0.40, two-tailed test). No statistically significant difference between the two arms of this study was noted with regard to toxicity or tumor recurrence.