A randomized study of intermittent chemotherapy with or without BCG inoculation in maintenance therapy of childhood ALL

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Abstract
One hundred ninety‐six children with acute lymphocytic leukemia were entered into a randomized study of maintenance chemotherapy with either intermittent chemotherapy and immunotherapy with bacillus Calmette‐Guerin (BCG) or only intermittent chemotherapy. On admission to the study, patients were stratified into three prognostic categories on the basis of clinical and laboratory features at presentation. Patients considered to have a favorable prognosis (PF) were induced with vincristine and prednisone; those with an unfavorable prognosis (PU) received combination chemotherapy consisting of either Ara‐C, cyclophosphamide and asparaginase, or vincristine, prednisolone, and daunomycin followed by Ara‐C and asparaginase; those with an average prognosis (PA) received vincristine and prednisolone followed by a single course of Ara‐C and asparaginase. All patients received central nervous system prophylaxis with 2,400 rad cranial irradiation and four injections of intrathecal methotrexate. One hundred seventy‐seven patients (90%) achieved complete remission, and 165 were randomized. Those randomized to Group A (83) received maintenance chemotherapy with six‐week courses of 6‐mercaptopurine, weekly oral methotrexate, and monthly vincristine. Each six‐week course was followed by a two‐week interval of no chemotherapy, and treatment was con tinued for 36 months. Patients randomized to Group B (82) received the same maintenance chemotherapy, but during the two‐week interval without chemotherapy, they were given BCG inoculation. With a median follow‐up of 110 weeks, no significant difference in duration of remission, survival, or CNS relapse was found between Groups A and B in the total patient population or within each prognostic category. In patients classified as PU, a significantly lower proportion (P < 0.02) remained in complete remission. Within this group, patients with a white cell count > 100 × 109/L had a significantly shorter duration of remission (P < 0.05). Patients classified as PF showed a This research was done by the Australasian Cancer Society Childhood Leukemia Group.