Comparison of Consolidation Strategies for Pediatric Patients With Acute Myeloid Leukemia: Results of the Randomized GATLA 8-LMA-P'07 Trial.
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OBJECTIVE: The primary objective was to determine whether consolidation (CONS) with 2 short chemotherapy cycles using cytarabine plus idarubicin and high dose cytarabine plus mitoxantrone (2-cycle) reduced the cumulative incidence of relapse compared with the standard regimen of a 6-week CONS phase among newly diagnosed pediatric patients with acute myeloid leukemia (AML). PATIENTS AND METHODS: GATLA 8-LMA-P'07 was a phase 3 trial conducted in 26 centers in Argentina. We included newly diagnosed pediatric patients with AML 0 to 18 years of age. Patients with M3 AML were excluded. After 2 cycles of induction, patients in remission were randomized to either CONS or 2-cycle CONS chemotherapy. High-risk patients received matched family stem cell transplantation or maintenance therapy for 12 months. RESULTS: One hundred seven patients younger than 18 years with de novo AML were randomized to CONS (n = 52) or 2-cycle (n = 57). Cumulative incidence (SE) of relapse was not significantly different between CONS (31% [0.1]) and 2-cycle (39% [0.1]) CONS ( P = 0.25). There was no significant difference in 5-year event-free survival (53.6% [0.8] vs 44.3 [0.7], P = 0.31) or 5-year overall survival (55.0% [0.8] vs 53.7% [0.7], P = 0.91) for CONS and 2-cycle CONS respectively. CONCLUSIONS: CONS with 2 cycles of chemotherapy was not significantly better than the standard CONS in reducing the cumulative risk of relapse among newly diagnosed children with AML from Argentina. Future research should evaluate new approaches to improve outcomes for pediatric patients with AML.