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

被引:6
作者
Bernal, Teresa [1 ,2 ]
Fernandez Moreno, Ainhoa [1 ,2 ]
de LaIglesia, Almudena [3 ]
Benavente, Celina [4 ]
Garcia-Noblejas, Ana [5 ]
Garcia Belmonte, Daniel [6 ]
Riaza, Rosalia [7 ]
Salamero, Olga [8 ]
Angeles Foncillas, Maria [9 ]
Roldan, Alicia [10 ]
Noriega Concepcion, Victor [11 ]
Llorente Gonzalez, Laura [12 ]
Bergua Burgues, Juan Miguel [13 ,16 ]
Lorente de Una, Soraya [14 ]
Rodriguez-Macias, Gabriela [15 ]
de la Fuente Burguera, Adolfo
Garcia Perez, Maria Jose [17 ]
Lopez-Lorenzo, Jose Luis [18 ]
Martinez, Pilar [19 ]
Alaez, Concepcion [20 ]
Callejas, Marta [21 ]
Martinez-Chamorro, Carmen [22 ]
Rifon Roca, Jose [23 ]
Amador Barciela, Lourdes [24 ]
Mena Duran, Armando V. [25 ]
Gomez Correcha, Karoll [26 ]
Lavilla Rubira, Esperanza [27 ]
Luz Amigo, Maria [28 ]
Vall-llovera, Ferran [29 ]
Garrido, Ana [30 ]
Garcia-Fortes, Maria [31 ]
de Miguel Llorente, Dunia [32 ]
Aules Leonardo, Anastasia [33 ]
Cervero, Carlos [34 ]
Coll Jorda, Rosa [35 ]
Perez-Encinas, Manuel M. [36 ]
Polo Zarzuela, Marta [4 ]
Figuera, Angela [5 ]
Rad, Guillermo [2 ]
Martinez-Cuadron, David [37 ]
Montesinos, Pau
机构
[1] Hosp Univ Cent Asturias, Oviedo, Spain
[2] Inst Invest Principado Asturias ISPA, Inst Oncol Principado Asturias IUOPA, Oviedo, Spain
[3] Hosp Puerta Hierro, Madrid, Spain
[4] Hosp Clin San Carlos, Madrid, Spain
[5] Hosp La Princesa, Madrid, Spain
[6] Hosp Univ Sanitas Zarzuela, Madrid, Spain
[7] Hosp Univ Severo Ochoa, Madrid, Spain
[8] Hosp Valle De Hebron, Barcelona, Spain
[9] Hosp Infanta Leonor, Madrid, Spain
[10] Univ Europea, Hosp Infanta Sofia San Sebastian de los Reyes, Dept Med, Madrid, Spain
[11] Complejo Hosp Univ A Coruna, La Coruna, Spain
[12] Hosp Univ HM Sanchinarro, Madrid, Spain
[13] Hosp San Pedro Alcantara, Caceres, Spain
[14] Hosp Vithas Xanit Int, Malaga, Spain
[15] Hosp Gregorio Maranon, Madrid, Spain
[16] MD Anderson Canc Ctr, Madrid, Spain
[17] Complejo Hosp Torre Cardenas, Almeria, Spain
[18] Hosp Univ Fdn Jimenez Diaz, Madrid, Spain
[19] Hosp Univ Doce Octubre, Madrid, Spain
[20] Hosp Univ Moncloa, Madrid, Spain
[21] Hosp Univ Principe Asturias, Madrid, Spain
[22] Hosp Univ Quiron Pozuelo, Madrid, Spain
[23] Clin Univ Navarra, Pamplona, Spain
[24] Complejo Hosp Pontevedra, Pontevedra, Spain
[25] Consorcio Hosp Gen Univ Valencia, Valencia, Spain
[26] Hosp Juan Ramon Jimenez, Huelva, Spain
[27] Hosp Lucus Augusti, Lugo, Spain
[28] Hosp Gen Univ Morales Messeguer, Murcia, Spain
[29] Hosp Mutua Tarrasa, Barcelona, Spain
[30] Hosp Santa Creu i Sant Pau, Barcelona, Spain
[31] Hosp Univ Virgen Victoria, Malaga, Spain
[32] Hosp Univ Guadalajara, Guadalajara, Spain
[33] Hosp Miguel Servet, Zaragoza, Spain
[34] Hosp Virgen Luz, Cuenca, Spain
[35] Hosp Univ Dr Josep Trueta, ICO Girona, Girona, Spain
[36] Hosp Univ Santiago Compostela, Santiago, Spain
[37] Hosp Univ & Politecn La Fe, Valencia, Spain
关键词
acute myeloid leukemia; clinical observations; intensive chemotherapy; real-world; OLDER PATIENTS; SECONDARY; RECOMMENDATIONS; DIAGNOSIS; FEATURES; AML;
D O I
10.1002/cam4.6120
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
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.
引用
收藏
页码:14892 / 14901
页数:10
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