TREATMENT OF NEWLY-DIAGNOSED CHILDREN AND ADOLESCENTS WITH ACUTE MYELOID-LEUKEMIA - A CHILDRENS CANCER GROUP-STUDY

Purpose: The objectives of this study were to determine if the additio n of etoposide, thioguanine, and dexamethasone to daunorubicin and cyt arabine (five-drug regimen) during induction would improve remission i nduction rates and survival of children with acute myeloid leukemia (A ML) when compared with the standard regimen of cytarabine and daunorub icin (7 + 3) and whether allogeneic bone marrow transplantation (BMT) or intensive chemotherapy consolidation with or without maintenance wo uld give a superior outcome. Patients and Methods: A total of 591 asse ssable children with AML entered Childrens Cancer Group (CCG) trial 21 3 between January 1986 and February 1989. The status of patients as of September 1, 1992 forms the basis of this report The results were com pared with previous AML studies. Results: The projected survival rate of all patients at 5 years is 39% (event-free survival [EFS] rate, 31% ), which is superior to that of the prior CCG study (P = .01). The ind uction rate was 79% for 7 + 3 and 76% for the five-drug regimen (not s ignificant). Comparisons of BMT to chemotherapy favored BMT, but these differences do not always reach statistical significance leg, 5-year disease-free survival [DFS] rate, 46% v 38% [P = .06] with donor avail able and 54% v 37% [P = .002] if treated according to protocol intent) . No benefit for maintenance therapy was found and, in some comparison s, it wets inferior to discontinuation of therapy (5-year survival rat e, 46% v 68%, P < .01). Conclusion: The 5-year EFS rate of patients wi th AML is 31% and has improved. The five-drug induction regimen is no better thorn standard induction, BMT appears superior to chemotherapy, and maintenance therapy was not beneficial.