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CPX-351 vs 7 + 3 in ND AML: A post hoc analysis of cardiotoxicity
Results from a post hoc analysis of the phase III CLTR0310-301 trial (NCT01696084), comparing cardiotoxicity between CPX-351 (a dual-drug liposomal encapsulation of daunorubicin + cytarabine; n = 57) and conventional 7 + 3 chemotherapy (cytarabine continuous infusion [Days 1–7] + once daily anthracycline [Days 1–3]; n = 45) in patients with acute myeloid leukemia (AML), were published in Cardio-Oncology by Mitchell et al. Patients were aged 60–75 years and had newly diagnosed therapy-related AML (tAML) or myelodysplasia-related AML (AML-MRC) and normal baseline left ventricular ejection fraction (LVEF) (≥53%). Cardiotoxicity was assessed through reported cardiac adverse events (AEs) and core lab assessment of echocardiograph changes in LVEF and/or left ventricular global longitudinal strain (GLS).
Key data: Clinically significant changes in LVEF (absolute decrease from baseline >10% with LVEF <53%) occurred less frequently in patients treated with CPX-351 vs 7 + 3 at follow-up 1 and/or 2 (8.8% vs 20.0%, respectively). By the final follow-up, no patients receiving CPX-351 had LVEF <53% compared with 17.8% of patients receiving 7 + 3. Clinically significant changes in global longitudinal strain (GLS) (relative decrease from baseline >12% with GLS <18%) were also less common with CPX-351 than with 7 + 3 (21.1% vs 44.4%). Cardiac AEs occurred at similar rates between groups (40.4% and 42.2% for CPX-351 and 7 + 3, respectively).
Key learning: CPX-351 may be associated with reduced cardiotoxicity compared with 7 + 3 in adults with tAML or AML-MRC, potentially attributable to lower cumulative anthracycline exposure and the cardioprotective effects of liposomal drug delivery, while maintaining the improved overall survival (OS) benefit demonstrated in the pivotal trial.
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