Experience with Bacillus Calmette-Guerin in Patients with Superficial Bladder Carcinoma

Abstract

A randomized study was done on 49 patients with a history of recurrent superficial transitional cell carcinoma of the bladder to determine if the frequency of tumor recurrence could be lessened. The patients were treated with 6 weekly instillations of Tice strain BCG or thiotepa, followed by instillations every 2 wk for 3 mo. and every month until a recurrence developed or the patients had been treated for 2 yr. Twelve additional patients who had previously failed on thiotepa were placed on the BCG protocol. There have been no recurrences in the BCG group; 9 patients (40%) in the thiotepa group suffered recurrences. All of the patients treated with BCG had symptoms of bladder irritability after each instillation. The same type of irritability occurred in 7 patients (25%) in the thiotepa group. Severe complications occurred in 11 patients treatd with BCG (28%), 4 of whom required hospitalization. Another 12 patients with visible transitional cell carcinoma were treated with weekly instillations of BCG. Of these patients, 6 had total resolution after 18 weekly instillations; 2 had no detectable tumor after 24 wk of therapy. Two patients were free of tumor after 6 instillations. Of 7 patients with carcinoma in situ treated with weekly instillations of BCG, 5 had complete resolution of the cellular atypia after 18 wk of therapy. These studies confirm and extend those of others; bladder instillations of BCG apparently are effective in reducing the recurrence rate in patients with superficial bladder tumor and can eliminate existing tumor in some patients. Symptoms of bladder irritability occur to a varying extent in every patient; severe systemic toxicity occurred in 28% of the patients.