Clinical outcomes after CPX-351 in patients with high-risk acute myeloid leukemia: A comparison with a matched cohort from the Spanish PETHEMA registry

Background: CPX-351 is approved for the treatment of therapy related acute myeloid leukemia (t-AML) and AML with myelodysplastic related changes (MRC-AML). The benefits of this treatment over standard chemotherapy has not been addressed in well matched cohorts of real-life patients. Methods: Retrosp...

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Autores: Bernal, T., Moreno, A.F., de LaIglesia, A., Benavente, C., García-Noblejas, A., Belmonte, D.G., Riaza, R., Salamero, O., Foncillas, M.A., Roldán, A., Noriega Concepción, Victor, González, L.L., Bergua Burgués, J.M., Lorente de Uña, S., Rodríguez-Macías, G., de la Fuente Burguera, A., García Pérez, M.J., López-Lorenzo, J.L., Martínez, P., Aláez, C., Callejas, M., Martínez-Chamorro, C., Roca, J.R., Barciela, L.A., Mena Durán, A.V., Gómez Correcha, K., Lavilla Rubira, Esperanza, Amigo, M.L., Vall-llovera, F., Garrido, A., García-Fortes, M., de Miguel Llorente, D., Leonardo, A.A., Cervero, C., Jordá, R.C., Pérez Encinas, Manuel Mateo, Zarzuela, M.P., Figuera, A., Rad, G., Martínez-Cuadrón, D., Montesinos, P.
Tipo de recurso: artículo
Fecha de publicación:2023
País:España
Institución:Servizo Galego de Saúde (SERGAS)
Repositorio:RUNA. Repositorio da Consellería de Sanidade e Sergas
OAI Identifier:oai:runa.sergas.gal:20.500.11940/21241
Acceso en línea:https://portalcientifico.sergas.gal//documentos/648600eaa219857f1d7899c6
http://hdl.handle.net/20.500.11940/21241
Access Level:acceso abierto
Palabra clave:Humans
Aged
Retrospective Studies
Cytarabine
Remission Induction
Leukemia, Myeloid, Acute
AS A Coruña
CHUAC
AS Lugo
CHULA
AS Santiago
CHUS
Descripción
Sumario:Background: CPX-351 is approved for the treatment of therapy related acute myeloid leukemia (t-AML) and AML with myelodysplastic related changes (MRC-AML). The benefits of this treatment over standard chemotherapy has not been addressed in well matched cohorts of real-life patients. Methods: Retrospective analysis of AML patients treated with CPX-351 as per routine practice. A propensity score matching (PSM) was used to compare their main outcomes with those observed in a matched cohort among 765 historical patients receiving intensive chemotherapy (IC), all of them reported to the PETHEMA epidemiologic registry. Results: Median age of 79 patients treated with CPX-351 was 67 years old (interquartile range 62-71), 53 were MRC-AML. The complete remission (CR) rate or CR without recovery (CRi) after 1 or 2 cycles of CPX-351 was 52%, 60-days mortality 18%, measurable residual disease <0.1% in 54% (12 out of 22) of them. Stem cell transplant (SCT) was performed in 27 patients (34%), median OS was 10.3 months, and 3-year relapse incidence was 50%. Using PSM, we obtained two comparable cohorts treated with CPX-351 (n = 52) or IC (n = 99), without significant differences in CR/CRi (60% vs. 54%) and median OS (10.3 months vs. 9.1 months), although more patients were bridged to SCT in the CPX-351 group (35% vs. 12%). The results were confirmed when only 3 + 7 patients were included in the historical cohort. In multivariable analyses, SCT was associated with better OS (HR 0.33 95% CI: 0.18-0.59), p < 0.001. Conclusion: Larger post-authorization studies may provide evidence of the clinical benefits of CPX-351 for AML in the real-life setting.

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