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

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 t o the study, patients were stratified into three prognostic categories on the basis of clinical and laboratory features at presentation. Patients considered t o 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 n o chemotherapy, and treatment was continued for 36 months. Patients randomized t o 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 X 109/L had a significantly shorter duration of remission (P < 0.05). Patients classified as P F showed a 354Ekert et a1 high incidence of late relapses and fared no better than those classified as PA. It is possible that the 2-drug induction regimen used in PF patients may have contributed to the relatively high late-relapse rate.

Risk factors for intellectual and educational sequelae of cranial irradiation in childhood acute lymphoblastic leukaemia

“…Group 1: 100 children diagnosed with ALL who had been treated with chemotherapy and cranial irradiation. Study III, 1977-81 (n = 15) (Ekert et al, 1980) Study IV, 1981 (n=40) (Ekert et al, 1990) and ANZCCSG Study V, 1985-92 (n=45) (Waters et al, 1992) (Wechsler, 1974) verbal (VIQ), performance (PIQ) and full-scale (FIQ) intellectual quotients (mean = 100, standard deviation= 15) and scaled scores (mean= 10, standard deviation= 3) for each of the 12 subtests were employed in statistical analyses of intellectual function.…”

Cytogenetics of acute lymphoblastic leukaemia in children as a factor in the prediction of long‐term survival

“…Patients were treated with the regimen of combination chemotherapy in use at the centre where they were diagnosed. Those in the U.K. were treated on UKALL I, 11, 111, IV or V (MacLennan et al, 1977); those in Japan with protocol number 6801 of Acute Leukaemia Group B (Holland & Glidewell, 1972); Boston patients received protocol 7301 (Sallan et al,19 78) and those from Melbourne received protocol study I1 or IV (Ekert et al, 1980). Eleven of the patients who presented before 1972 (London), or before 1974, or were less than 1 year old (Melbourne) did not receive early central nervous system (CNS) prophylaxis.…”

A morphometric classification of acute lymphoblastic leukemia in children

“…These children had been treated with one of the three different protocols used in the recent Australasian Leukemia Study III [8].…”

“…Bone marrow smears obtained from 99 ALL children attending the Royal Children's Hospital in Melbourne and the Adelaide Children's Hospital, Adelaide, South Australia, were randomly selected from the patients with a median follow-up of at least 3 years. These children had been treated with one of the three different protocols used in the recent Australasian Leukemia Study III [8].…”