Objective: To evaluate the outcomes of childhood acute myeloid leukemia (AML) treated with AML-XH-99 protocol and explore how to improve the event-free survival (EFS) rate.
Methods: Eighty-two patients entered AML-XH-99 clinical trial. Survival rates were evaluated by Kaplan-Meier method with SPSS.
Results: Among the 82 patients, 58 (70.7%) achieved complete remission (CR) after one course treatment, and the total CR rate was 84.1%. The overall 5 year EFS rate was (46.1 +/- 9.1)% and disease-free survival (DFS) rate was (54.3 +/- 10.3)% over a median observation period of 23 months. The 5 year EFS rate of 56 patients received high-dose cytarabine(HD-Ara-C) as intensification therapy was (47.2 +/- 12.9)%. Relapse occurred in 19 patients (26.0%) with a median time of 10 months (ranges 2 approximately 53 months), 28 patients died.
Conclusion: AML-XH-99 protocol resulted in a higher CR rate, especially one course CR rate, which was one of the key factors for long-term EFS and HD-Ara-C intensification therapy was effective in the treatment of childhood AML.