Bacillus Calmette-guerin Immunotherapy of Superficial Bladder Cancer

Abstract

Patients (37) were enrolled in a randomized prospective study to compare standard surgical therapy for superficial bladder cancer to standard therapy BCG. Side effects of BCG were tolerated well and include dysuria in 95% of the patients, urinary frequency in 83%, hematuria in 39%, fever in 22% and nausea in 22%. Of 19 control patients, 8 (42%) had recurrent tumors in the follow-up period, compared to 3 of 18 patients (17%) treated with BCG. One patient treated with BCG had 2 recurrences, yielding a recurrence rate of 22% in the group receiving BCG compared to 42% in controls. When the incidence of recurrent tumors in matched intervals before and after entry into the protocol is compared, no change in the rate of tumor recurrence (P = 0.726 .chi.2) occurred in controls; tumor recurrences were reduced significantly in the group treated with BCG (P = 0.010 .chi.2). The reduction in tumor recurrence in patients treated with BCG compared to controls is statistically significant (P = 0.029 .chi.2). Of 4 patients with previous stage B disease treated with BCG 3 have remained free of tumor. Three patients who presented with new bladder tumors remain free of tumor after BCG therapy; 2 of 5 comparable control patients developed recurrent tumors. Intravesical and percutaneous BCG immunotherapy appears to decrease the rate of tumor recurrence in patients followed for 1 yr.