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Oncology Learning NetworkCPX-351 vs. FLAG-Ida Treatment for Patients with Adverse Karyotype AML/High-Risk MDS

UK NCRI AML19 Trial Finds Comparable Overall Survival Rates Between Two Treatment Regimens

New findings from the UK NCRI AML19 trial indicate that younger patients with adverse risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) show no significant difference in overall survival when treated with either liposomal daunorubicin and cytarabine (CPX-351) or the standard-of-care regimen of fludarabine, cytarabine, idarubicin, and granulocyte colony-stimulating factor (FLAG-Ida).

HCN Medical Memo
These findings underscore the need for further research to identify the most effective treatment regimens for younger AML/MDS patients with adverse risk profiles. Although CPX-351 shows promise in extending relapse-free survival, it does not significantly impact overall survival compared to FLAG-Ida, suggesting that treatment decisions should be individualized based on patient characteristics and genetic markers.

Key Points
  • 189 patients with a median age of 56 were studied; 49% had de novo AML, 20% had secondary AML, and 30% had high-risk MDS.
  • Overall response rate was 64% for CPX-351 and 76% for FLAG-Ida.
  • No significant difference in overall survival (OS) or event-free survival between the two treatments.
  • Relapse-free survival was significantly longer with CPX-351 (22.1 vs 8.35 months).
  • Jad Othman, MD, emphasized the lack of prior randomized studies in younger patients.

The median age of diagnosis for acute myeloid leukemia (AML) is around 68 years, making the study’s median age of 56 notably younger.

Additional Points:
  • TP53 was the most commonly mutated gene, found in 43% of patients.
  • An exploratory subgroup with MDS-related gene mutations had significantly longer OS with CPX-351 (38.4 vs. 16.3 months).

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