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Acute myeloid leukemia with myelodysplasia-related changes (AML-MRC) is associated with poor prognosis after induction therapy. CPX-351, a liposomal combination of daunorubicin (D) plus cytarabine (C), demonstrated a significantly improved median overall survival (OS) compared to a standard 7+3 regimen in older patients (60–75 years of age) with newly diagnosed high-risk or secondary AML.1 An interview with Jeffrey E. Lancet discussing results of the trial is available here. You can also read about the impact of gene mutations on the efficacy of combination here.
Daniel H.Ryan and colleagues conducted an exploratory subgroup analysis of a phase III study (NCT01696084) comparing outcomes in patients who achieved complete remission (CR) or CR with an incomplete neutrophil/platelet recovery (CRi) across treatment groups.2 These data were presented at the Transplantation & Cellular Therapy Meeting February, 19–23, 2020, Florida, US.
Table 1. Treatment-emergent adverse events
TEAE, treatment-emergent adverse event |
||
TEAE |
CPX-351 |
7+3 |
TEAEs in ≥ 50% of patients in either group, % Febrile neutropenia Constipation Nausea Peripheral edema Fatigue Diarrhea |
78 58 53 49 47 37 |
80 55 53 65 50 78 |
Serious TEAEs in ≥ 10% of patients in either group, % Febrile neutropenia Decreased ejection fraction |
10 8 |
13 10 |
The authors demonstrated improved median OS with CPX-351 compared to 7+3 chemotherapy in patients with AML-MRC who achieved CR + CRi. The safety profile in this subgroup was consistent with the overall study population.1,2
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