Complications of BCG immunotherapy in patients with cancer.

Abstract Eighty-two patients with solid neoplasms were treated with BCG. BCG was well tolerated when given intradermally and alone by the multiple-puncture tine technic (24 patients) or with a tumor-cell vaccine (34 patients). Intratumor injection of BCG was associated with frequent complications, including marked malaise and an influenza-like syndrome in 16 of 25 patients, a temperature of 40°C or higher in 12, reversible hepatic dysfunction in six, and jaundice in three patients. Antituberculous chemotherapy with isoniazid promptly alleviated symptoms in seven patients so treated. BCG administration appears to be well tolerated with the multiple-puncture technic, but the intra-tumor injection of BCG may be associated with more serious side effects. (N Engl J Med 289:827–830, 1973)

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