INTRAVESICAL BACILLUS-CALMETTE-GUERIN FOR SUPERFICIAL BLADDER CANCER - EXPERIENCE WITH DANISH-1331 STRAIN

A total of 95 patients with stage Ta/T1 superficial bladder cancer was eligible for intravesical bacillus Calmette-Guerin (BCG) immunoprophy laxis according to the standard high risk criteria for tumor recurrenc e and progression. Of these patients 50 agreed to undergo treatment wh ile the remaining 45 refused any intravesical therapy and served as co ncurrent nonrandomized controls. The patient and tumor characteristics in the 2 groups of patients were identical. All patients underwent co mplete transurethral resection of the bladder tumor. Therapy consisted of 120 mg. weekly instillations of BCG (Danish 1331 strain) for 6 wee ks. Among the 50 patients 33 received BCG initially while 17 received it after failure of intravesical chemotherapy. Responses were evaluate d according to standard criteria. Recurrence was noted in 24 patients (48%) in the BCG group compared to 38 (84.4%) in the control group. Th e recurrence rates per year and per 100 patient-months were significan tly reduced in the BCG arm compared to the control arm. The mean inter val to first recurrence and the mean recurrence interval were signific antly increased in the BCG arm compared to the control arm. The relati ve risk of recurrence in the BCG group was 0.62 versus 1.63 in the con trol group. Subgroup analysis showed significant benefit of BCG for pa tients with single as well as multiple, stages Ta and T1, and grades I I and III tumors. Comparison with pretreatment controls in the BCG gro up revealed a significant reduction in the recurrence rate in those pa tients after treatment with BCG, which was not seen in the control gro up. The benefit of BCG was seen in those who received BCG initially as well as in those who received it after failure of intravesical chemot herapy. Multivariate analysis of prognostic factors showed that this b enefit in the BCG group was related only to the treatment, while other prognostic parameters, such as tumor stage, grade, number and so fort h were not independent prognostic variables. The rate of progression t o muscle invasion was not significantly different in the 2 treatment g roups. The relapse-free survival in the BCG group was 35.4% at 60 mont hs compared to 11.2% in the control group (p < 0.001). The side effect s of BCG therapy were mild, brief and easily controlled with conservat ive measures.