GATLA 8-LMA-P’07: 2-cycle consolidation vs standard 6-week consolidation chemotherapy in newly diagnosed pediatric AML

While intensive anthracycline and cytarabine-based chemotherapy have demonstrated improved outcomes in patients with acute myeloid leukemia (AML), intensive chemotherapy is associated with toxicity and resource utilization, and improved survival outcomes have not been validated in low- and middle-income countries.

Deana et al. recently published findings from the randomized phase III GATLA 8-LMA-P’07 trial (NCT06211452) in Argentina, in the Journal of Pediatric Hematology/Oncology. The trial investigated whether further intensification of chemotherapy – based on two short consolidation cycles with anthracyclines and cytarabine – reduced the cumulative incidence of relapse vs standard 6-week consolidation, in pediatric patients aged 0 to 18 years with newly diagnosed AML. Following two induction cycles, patients in remission were treated with either a standard consolidation chemotherapy regimen (n = 50) or 2-cycle consolidation with cytarabine + idarubicin + high-dose cytarabine + mitoxantrone (n = 57). The primary outcome was 5-year cumulative incidence of relapse.

Key learnings

There was no significant difference in 5-year CIR between the standard consolidation and 2-cycle consolidation regimens (CIR [SE], 31% [0.1] vs 39% [0.1]; p = 0.25).

5-year EFS was not significantly different between the standard consolidation and 2-cycle consolidation regimens (53.6% [0.8] vs 44.3 [0.7]; p = 0.31), nor was 5-year overall survival (55.0% [0.8] vs 53.7% [0.7]; p = 0.91).

TRM occurred in six patients receiving standard consolidation and in two patients receiving 2-cycle consolidation; the most common cause of TRM in both groups was infection. 

The 2-cycle consolidation regimen did not significantly improve outcomes vs standard consolidation in pediatric patients in Argentina with newly diagnosed AML. Future research should explore new strategies, including supportive care, to improve outcomes.