References
- VYXEOS [package insert]. Palo Alto, CA: Jazz Pharmaceuticals.
- Lalayanni C, Gavriilaki E, Athanasiadou A, et al. Secondary acute myeloid leukemia (sAML): similarly dismal outcomes of AML after an antecedent hematologic disorder and therapy related AML. Clin Lymphoma Myeloma Leuk. 2022;22(4):e233-e240.
- Capelli D, Menotti D, Florentini A, Sarcani F, Olivieri A. Chapter 7: Secondary acute myeloid leukemia: pathogenesis and treatment. Accessed July 15, 2024. https://www.ncbi.nlm.nih.
gov/books/NBK586211/?report=printable
- Granfeldt Østgård LS, Medeiros BC, Sengeløv H, et al. Epidemiology and clinical significance of secondary and therapy-related acute myeloid leukemia: a national population-based cohort study. J Clin Oncol.
2015;33(31):3641-3649.
- Leone G, Mele L, Pulsoni A, et al. The incidence of secondary leukemias. Haematologica. 1999;84(10):937-945.
- National Cancer Institute Surveillance, Epidemiology, and End Results Program. SEER hematopoietic and lymphoid neoplasm database: acute myeloid leukemia with myelodysplasia-related changes. Accessed July 15, 2024. https://seer.cancer.gov/seertools/
hemelymph/51f6cf58e3e27c3994bd53a
e/?q=aml-mrc
- Arber DA, Erba HP. Diagnosis and treatment of patients with acute myeloid leukemia with myelodysplasia-related changes (AML-MRC). Am J Clin Pathol. 2020;154(6):731-741.
- Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed July 15, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
- Miesner M, Haferlach C, Bacher U, et al. Multilineage dysplasia (MLD) in acute myeloid leukemia (AML) correlates with MDS-related cytogenetic abnormalities and a prior history of MDS or MDS/MPN but has no independent prognostic relevance: a comparison of 408 cases classified as “AML not otherwise specified” (AML-NOS) or “AML with myelodysplasia-related changes” (AML-MRC). Blood. 2010;116(15):2742-2751.
- Lancet JE, Uy GL, Newell LF, et al. CPX-351 versus 7+3 cytarabine and daunorubicin chemotherapy in older adults with newly diagnosed high-risk or secondary acute myeloid leukaemia: 5-year results of a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2021;8(7):e481-e491.
- Lin TL, Medeiros BC, Uy GL, et al. Outcomes by number of induction cycles with CPX-351 vs 7+3 chemotherapy in older adults with newly diagnosed high-risk/secondary acute myeloid leukemia (sAML). Presented at: American Society of Clinical Oncology Annual Meeting; June 1-5, 2018; Chicago, IL. Poster 7040.
- Supplement to: Lancet JE, Uy GL, Newell LF, et al. CPX-351 versus 7+3 cytarabine and daunorubicin chemotherapy in older adults with newly diagnosed high-risk or secondary acute myeloid leukaemia: 5-year results of a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2021;8(7):e481-e491.
- Lancet JE, Uy GL, Cortes JE, et al. CPX-351 (cytarabine and daunorubicin) liposome for injection versus conventional cytarabine plus daunorubicin in older patients with newly diagnosed secondary acute myeloid leukemia. J Clin Oncol. 2018;36(26):2684-2692.
- Mitchell JD, Pfeiffer M, Boehmer J, et al. P516: Cardiotoxivity of CPX-351 vs 7+3 in patients with untreated high-risk acute myeloid leukemia. Hemasphere. 2023;7(Suppl):e178806c.
- Mitchell JD, Pfeiffer M, Boehmer J, et al. P516: Cardiotoxicity of CPX-351 vs 7+3 in patients with untreated high-risk acute myeloid leukemia. Poster presented at: EHA2023 (European Hematology Association) Hybrid Congress; June 8–11, 2023; Frankfurt, Germany.
- Gyawali B, Parsad S, Feinberg BA, Nabhan C. Real-world evidence and randomized studies in the precision oncology era: the right balance. JCO Precis Oncol. 2017; doi: 10.1200/PO.17.00132.
- Rautenberg C, Stölzel F, Röllig C, et al. Real-world experience of CPX-351 as first-line treatment for patients with acute myeloid leukemia. Blood Cancer J. 2021;11(10):164.
- Chiche E, Rahmé R, Bertoli S, et al. Real-life experience with CPX-351 and impact on the outcome of high-risk AML patients: a multicentric French cohort. Blood Adv. 2021;5(1):176-184.
- Guolo F, Fianchi L, Minetto P, et al. CPX-351 treatment in secondary acute myeloblastic leukemia is effective and improves the feasibility of allogeneic stem cell transplantation: results of the Italian compassionate use program. Blood Cancer J. 2020;10(10):96.
- Cluzeau T, Lemoli RM, McCloskey J, Cooper T. Measurable residual disease in high-risk acute myeloid leukemia. Cancers (Basel). 2022;14(5):1278.
- Kim HS, Lee S, Kim JH. Real-world evidence versus randomized controlled trial: clinical research based on electronic medical records. J Korean Med Sci. 2018;33(34):e213.
- Vyxeos Liposomal EU Summary of Product Characteristics. Jazz Pharmaceuticals, Inc.
- Mayer LD, Tardi P, Louie AC. CPX-351: a nanoscale liposomal co-formulation of daunorubicin and cytarabine with unique biodistribution and tumor cell uptake properties. Int J Nanomedicine. 2019;14:3819-3830.
- Feldman EJ, Lancet JE, Kolitz JE, et al. First-in-man study of CPX-351: a liposomal carrier containing cytarabine and daunorubicin in a fixed 5:1 molar ratio for the treatment of relapsed and refractory acute myeloid leukemia. J Clin Oncol. 2011;29(8):979-985.
Definitions
AML=acute myeloid leukemia; ANC=absolute neutrophil count; CNS=central nervous system; CR=complete remission; CRi=complete remission with incomplete count recovery; ECOG PS=Eastern Cooperative Oncology Group Performance Status; GLS=global longitudinal strain; HMA=hypomethylating agent; HR=hazard ratio; HSCT=hematopoietic stem-cell transplantation; KM=Kaplan-Meier; LVEF=left ventricular ejection fraction; MDS=myelodysplastic syndromes; MFC=multiparameter flow cytometry; MRC=myelodysplasia-related changes; MRD=minimal/measurable residual disease; NR=not reached; OS=overall survival; sAML=secondary acute myeloid leukemia; t-AML=therapy-related acute myeloid leukemia; WHO=World Health Organization; WT1=Wilms tumor 1.