Bacillus Calmette-Guerin Immunotherapy for Bladder Cancer

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Abstract
BCG immunotherapy has been found by a number of investigators to be effective in the treatment and prevention of superficial bladder cancer. While the optimal protocol for BCG remains to be determined, experience with 92 randomized and 30 nonrandomized (high risk) patients followed for up to 5 yr provides information that may improve future protocols. Side effects of BCG are observed to increase with increasing frequency and duration of treatment. The protection from tumor recurrence has persisted: only 6 of 30 patients (20%) treated with bacillus Calmette-Guerin have had recurrent tumor compared to 14 of 27 controls (52%, P = 0.008, chi-square test) and mean time to recurrence increased from 24-48 mo. (P < 0.005, Savage). Skin test reactivity to purified protein derivative is particularly useful in predicting response to BCG immunotherapy. Currently, 60 patients have been randomized to receive BCG immunotherapy and only 1 of 22 patients (4.5%) in whom the purified protein derivative skin test results converted from negative to positive has had recurrent tumor, compared to 12 recurrences (32%) in patients whose skin tests were positive before treatment or failed to convert following treatment (P = 0.014, chi-square). Seven recurrences (33%) developed in 21 patients whose skin tests remained negative (P = 0.015) and 5 recurrences (29%) developed in 17 patients whose tests previously were positive (P = 0.068, Fisher''s test, not significant). The benefit of percutaneous BCG is suggested by the observations that the recurrence rate in patients treated with intravesical BCG alone is 40% and all 7 patients whose purified protein derivative skin tests were negative continued to have negative results when percutaneous BCG was omitted (P = 0.003). Among high risk patients a marked decrease in or complete prevention of recurrent tumor was observed in 82% of 22 patients treated previously with chemotherapy and 11 of 14 (78%) wich carcinoma in situ have had a complete response.