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

Autores: Bernal, T.; Fernández Moreno, A.; de LaIglesia, A.; Benavente, C.; García-Noblejas, A.; García Belmonte, D.; Riaza, R.; Salamero, O.; Foncillas, M. A.; Roldán, A.; Noriega Concepción, V.; Llorente González, 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.; Rifón Roca, José Juan; Amador Barciela, L.; Mena Durán, A. V.; Gómez Correcha, K.; Lavilla Rubira, E.; Amigo, M. L.; Vall-Llovera, F.; Garrido, A.; García-Fortes, M.; de Miguel Llorente, D.; Aules Leonardo, A.; Cervero, C.; Coll Jordá, R.; Pérez-Encinas, M. M.; Polo Zarzuela, M.; Figuera, A.; Rad, G.; Martínez-Cuadrón, D.; Montesinos, P.
Título de la revista: CANCER MEDICINE
ISSN: 2045-7634
Volumen: 12
Número: 14
Páginas: 14892 - 14901
Fecha de publicación: 2023
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.