The Immunotherapy of Acute Myelogenous Leukaemia using Intravenous BCG

Abstract

In a 2 yr period, 37 of 81 adults with acute myelogenous leukemia achieved complete remission after repeated courses of daunorubicin (DNR) and cytosine arabinoside (ARAC). They were randomized to maintenance treatment with monthly DNR/ARAC, or identical chemotherapy plus i.v. BCG. Eighteen BCG treated patients had significantly longer survival times than 19 patients treated with chemotherapy only, although no statistically significant difference can be seen in the remission duration of the 2 groups. Eleven patients in the BCG treated group who relapsed, received DNR/ARAC reinduction and 5 second and 2 third remissions were obtained. Twelve control patients relapsed and 10 received further reinduction treatment with DNR/ARAC, but only 1 patient entered complete remission. Seven patients in the BCG treated group who survived for 75 wk or more (76, 76, 96, 124, 125, 138 and 145 wk) were PPD [purified protein derivative] positive before treatment or converted to PPD positivity after BCG treatment. Using a battery of skin tests it may be possible to define a good prognostic group of patients and design future treatment accordingly. The BCG group had 198 i.v. treatments. All patients had pyrexia 6-12 h after injection lasting 12-72 h and occasionally headaches and muscle pains. Two patients had nonfatal anaphylactic reactions which did not recur when BCG was subsequently readministered. Other complications of BCG therapy were not a problem and treatment was not withdrawn for any patient.