Efficacy and safety of CPX-351 versus 7 + 3 chemotherapy by European LeukemiaNet 2017 risk subgroups in older adults with newly diagnosed, high-risk/secondary AML: post hoc analysis of a randomized, phase 3 trial

• Published in: Journal of hematology and oncology Vol. 15; no. 1; pp. 155 - 6
• Main Authors: Cortes, Jorge E, Lin, Tara L, Asubonteng, Kobby, Faderl, Stefan, Lancet, Jeffrey E, Prebet, Thomas
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 26.10.2022; BioMed Central; BMC
• Subjects: Acute myeloid leukemia; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Bone marrow; Brief Report; Cancer; Care and treatment; Chemotherapy; CPX-351; Cytarabine; Cytarabine - adverse effects; Daunorubicin; Daunorubicin - adverse effects; European LeukemiaNet 2017 risk subgroup; Hematology; Humans; Leukemia; Leukemia, Myeloid, Acute; Mortality; Mutation; Neoplasms, Second Primary - drug therapy; Neutropenia; Older people; Oncology; Patients; Population studies; Post hoc; Remission; Risk groups; Survival; United States > US; Europe; Chemotherapy; Acute myeloid leukemia; Post hoc; European LeukemiaNet 2017 risk subgroup; CPX-351
• ISSN: 1756-8722; 1756-8722
• DOI: 10.1186/s13045-022-01361-w

CPX-351 (Europe: Vyxeos liposomal; United States: Vyxeos ) is a dual-drug liposomal encapsulation of daunorubicin and cytarabine in a synergistic 1:5 molar ratio. In a phase 3 study in older adults with newly diagnosed, high-risk/secondary AML, CPX-351 improved the remission frequency, overall survival, and post-transplant survival versus 7 + 3. This post hoc analysis evaluated the final 5-year follow-up outcomes according to the European LeukemiaNet 2017 risk classification. CPX-351-treated patients had a higher remission frequency (adverse risk: 41% vs 26%; intermediate risk: 58% vs 39%) and longer median overall survival (adverse risk: 7.59 vs 5.52 months; intermediate risk: 11.86 vs 7.75 months) and post-transplant survival (adverse risk: 43.14 vs 7.08 months; intermediate risk: not reached vs 13.57 months) versus 7 + 3, with outcomes generally poorer among patients with adverse-risk AML. The safety profile of CPX-351 among patients with adverse-risk or intermediate-risk AML was consistent with that of the overall study population. Early mortality was lower, and hospitalization length of stay per patient-year was shorter with CPX-351 versus 7 + 3 within the adverse-risk and intermediate-risk subgroups. The favorable outcomes observed with CPX-351 in this post hoc analysis are consistent with results for the overall study population and further support the use of CPX-351 in these patients.ClinicalTrials.gov Identifier: NCT01696084.