Use of Venetoclax in Patients with Relapsed or Refractory Acute Myeloid Leukemia: The PETHEMA Registry Experience
Por:
Labrador, J, Saiz-Rodriguez, M, de Miguel, D, de Laiglesia, A, Rodriguez-Medina, C, Vidriales, MB, Perez-Encinas, M, Sanchez-Sanchez, MJ, Cuello, R, Roldan-Perez, A, Vives, S, Benzo-Callejo, G, Colorado, M, Garcia-Fortes, M, Sayas, MJ, Olivier, C, Recio, I, Conde-Royo, D, Bienert-Garcia, A, Vahi, M, Munoz-Garcia, C, Seri-Merino, C, Tormo, M, Vall-llovera, F, Foncillas, MA, Martinez-Cuadron, D, Sanz, MA and Montesinos, P
Publicada:
1 abr 2022
Resumen:
Simple Summary The use of venetoclax combined with hypomethylating agents or low-dose cytarabine in patients with newly diagnosed acute myeloid leukemia unfit for intensive chemotherapy was recently approved. However, the evidence in relapse or refractory patients is still scarce. The cohort of patients included in our study was heavily pretreated and had a poor performance status. It is still necessary to identify those patients at higher risk of early death who would not benefit from this type of treatment. For these ultra-high-risk patients, other treatment strategies should be followed. The effectiveness of venetoclax (VEN) in relapsed or refractory acute myeloid leukemia (RR-AML) has not been well established. This retrospective, multicenter, observational database studied the effectiveness of VEN in a cohort of 51 RR-AML patients and evaluated for predictors of response and overall survival (OS). The median age was 68 years, most were at high risk, 61% received >= 2 therapies for AML, 49% had received hypomethylating agents, and ECOG was >= 2 in 52%. Complete remission (CR) rate, including CR with incomplete hematological recovery (CRi), was 12.4%. Additionally, 10.4% experienced partial response (PR). The CR/CRi was higher in combination with azacitidine (AZA; 17.9%) than with decitabine (DEC; 6.7%) and low-dose cytarabine (LDAC; 0%). Mutated NPM1 was associated with increased CR/CRi. Median OS was 104 days (95% CI: 56-151). For the combination with AZA, DEC, and LDAC, median OS was 120 days, 104 days, and 69 days, respectively; p = 0.875. Treatment response and ECOG 0 influenced OS in a multivariate model. A total of 28% of patients required interruption of VEN because of toxicity. Our real-life series describes a marginal probability of CR/CRi and poor OS after VEN-based salvage. Patients included had very poor-risk features and were heavily pretreated. The small percentage of responders did not reach the median OS.
Filiaciones:
Labrador, J:
Hosp Univ Burgos, Hematol Dept, Burgos 09006, Spain
Hosp Univ Burgos, Fdn Burgos Invest Salud FBIS, Res Unit, Burgos 09006, Spain
Saiz-Rodriguez, M:
Hosp Univ Burgos, Fdn Burgos Invest Salud FBIS, Res Unit, Burgos 09006, Spain
de Miguel, D:
Hosp Univ Guadalajara, Hematol Dept, Guadalajara 19002, Spain
de Laiglesia, A:
Hosp Univ Puerta Hierro, Hematol Dept, Madrid 28222, Spain
Rodriguez-Medina, C:
Hosp Gran Canaria Dr Negrin, Hematol Dept, Las Palmas Gran Canaria 35010, Spain
Vidriales, MB:
Hosp Univ Salamanca, Hematol Dept, Salamanca 37007, Spain
Perez-Encinas, M:
Hosp Clin Univ Santiago de Compostela, Hematol Dept, Santiago De Compostela 15706, Spain
Sanchez-Sanchez, MJ:
Hosp Univ Lucus Augusti, Hematol Dept, Lugo 27003, Spain
Cuello, R:
Hosp Clin Univ Valladolid, Hematol Dept, Valladolid 47003, Spain
Roldan-Perez, A:
Hosp Univ Infanta Sofia, Hematol Dept, Madrid 28703, Spain
:
Hosp Germans Trias & Pujol ICO, Hematol Dept, Badalona 08907, Spain
Benzo-Callejo, G:
Hosp Univ Princesa, Hematol Dept, Madrid 28006, Spain
Colorado, M:
Hosp Univ Marques Valdecilla, Hematol Dept, Santander 39008, Spain
Garcia-Fortes, M:
Hosp Univ Virgen Victoria, Hematol Dept, Malaga 29010, Spain
Sayas, MJ:
Hosp Univ Doctor Peset, Hematol Dept, Valencia 46017, Spain
Olivier, C:
Hosp Gen Segovia, Hematol Dept, Segovia 40002, Spain
Recio, I:
Complejo Asistencial Avila, Hematol Dept, Avila 05071, Spain
Conde-Royo, D:
Hosp Univ Principe Asturias, Hematol Dept, Madrid 28805, Spain
Bienert-Garcia, A:
Hosp Univ Canarias, Hematol Dept, Santa Cruz De Tenerife 38320, Spain
Vahi, M:
Hosp Univ Virgen Valme, Hematol Dept, Seville 41014, Spain
Munoz-Garcia, C:
Hosp Univ Virgen Macarena, Hematol Dept, Seville 41009, Spain
Seri-Merino, C:
Hosp Cent Def Gomez Ulla, Hematol Dept, Madrid 28047, Spain
Tormo, M:
Hosp Clin Univ Valencia, Hematol Dept, Valencia 46010, Spain
Vall-llovera, F:
Hosp Univ Mutua Terrasa, Hematol Dept, Barcelona 08221, Spain
Foncillas, MA:
Hosp Univ Infanta Leonor, Hematol Dept, Madrid 28031, Spain
Martinez-Cuadron, D:
Hosp Univ I Politecn La Fe, Hematol Dept, Valencia 46026, Spain
Sanz, MA:
Hosp Univ I Politecn La Fe, Hematol Dept, Valencia 46026, Spain
Montesinos, P:
Hosp Univ I Politecn La Fe, Hematol Dept, Valencia 46026, Spain
gold, Green Published
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