Aerosolized BCG (Tice strain) treatment of bronchogenic carcinoma: phase I study.

Twenty patients with pathologically proved non-resectable bronchogenic carcinoma were treated with 100 aerosolized BCG (Tice strain) doses in addition to conventional treatment. The procedure is based on findings that, generally BCG must be closely associated with neoplastic cells to be effective as an immunotherapeutic agent. Bronchogenic malignancy, usually of mucosal origin, is logically treated in this manner. We report here the findings and developments of 10 patients who were treated at least five times each (for a total of 81 treatments) and pertinent experience relating to these and another 10 patients treated a total of 19 times. Local and systemic reactions were frequent and consisted of fever, cough, dyspnea, nausea, vomiting, anorexia, and malaise. Four of the 20 patients (20%) had reactions with the first treatment; by the fourth treatment 6 of 6 (100%) were affected. Prednisone given prophylactically reduced the intensity and the frequency of reactions. There were no severe side effects, obvious BCG infections, or significant changes in pulmonary or liver functions or hematologic values. No patient acquired purified protein derivative sensitivity, although 3 persons converted other skin tests to positive. There was no improvement in actuarial survival time.