Real‐World Outcomes of FLAG ‐Ida Regimen in 1079 Adult Patients With First Relapsed/Refractory AML : A PETHEMA Study
Year: 2026
Type: article
Study design: Observational Study
Abstract: In a large multicenter real-world cohort, we aimed to evaluate outcomes of FLAG-Ida salvage therapy for relapsed/refractory (R/R) acute myeloid leukemia (AML) and validated the SALFLAGE prognostic score. We analyzed 1079 adults with R/R AML treated across 112 PETHEMA institutions over 26 years (1998-2024), including patients with primary refractory disease (36.9%) and first relapse episode (63.1%), with a median age of 52 years. Complete remission composite (CRc) was achieved 56.8%, including complete remission (CR) in 51.0%, CR with incomplete recovery in 4.0%, and morphological-free-state in 1.8%, enabling 35.2% of patients and 62% of responders to proceed to allogeneic transplantation without morphological disease. With median follow-up of 50.9 months, median overall survival (OS) was 10.2 months, with 5-year OS rate of 21.6%. Prior allogeneic transplantation (HR 0.54; p < 0.001) and relapse-free interval ≥ 1 year (HR 0.75; p = 0.024) independently predicted improved OS, whereas modified high-risk cytogenetics including t(8; 21) (HR 3.58; p < 0.001), FLT3-ITD mutation at primary diagnosis (HR 1.61; p < 0.001), and age ≥ 60 (HR 1.43; p < 0.001) conferred inferior OS. Validation of the SALFLAGE score demonstrated moderate discrimination (C-index 0.67), with 5-year survival of 38.4%, 27.2%, and 12.7% across risk categories (p < 0.001). Outcomes improved over periods (1998-2005 vs. 2006-2016 vs. 2017-2024): 30-day mortality was 6.9% vs. 9.3% vs. 5.0%, respectively (p = 0.030), and median OS was 7.8 versus 9.4 versus 11.1 months, respectively (p = 0.16). We confirm FLAG-Ida as a reference salvage regimen in fit R/R AML and validate the SALFLAGE score in this setting.
Source: American Journal of Hematology
DOI: 10.1002/ajh.70340
Authors: Gaspar Aspas Requena, Rebeca Rodríguez‐Veiga, Cristina Gil, Carmen Botella, Eliana Aguiar, Fernanda Trigo, Mercedes Colorado, Teresa del Bernal del Castillo, Eva Barragan, Mar Tormo, Eduardo Rodríguez Arbolí, Josefina Serrano López, Raimundo García Boyero, Tamara Castaño, Pilar Herrera Puente, Mónica A. Romero Riquelme, María J. Sayas Lloris, Lorenzo Algarra‐Algarra, Carlos Rodriguez‐Medina, Claudia L. Sossa Melo, Jorge Labrador Gomez, Susana Vives, Olga Salamero, María Luz Amigo, Marta Valero Nuñez, Christine Rojas, Francisca Bass, María García‐Fortes, Belén Vidriales Vicente, Marta Polo, Celina Benavente, María D. Madrigal, Marcela Espinoza, Manuel Pérez‐Encinas, María L. Amador Barciela, Guiomar Bautista, Antonio Solana‐Altabella, Isabel Cano‐Ferri, Rafael Colmenares, Patricia García‐Ramírez, Francisco Ibáñez Alis, Manuel Barrios García, Gabriela Rodríguez‐Macías, Miguel López, Ana Yurena Oliva Hernández, Carlos Javier Cerveró, David Martínez‐Cuadrón, Pedro Chorão, Juan M. Bergua Burgues, Pau Montesinos
Institutions: Université de Montpellier, Centre Hospitalier Universitaire de Montpellier, Hospital Universitari i Politècnic La Fe, Hospital de São João, Marqués de Valdecilla University Hospital, Hospital Universitario Central de Asturias, Hospital Clínico Universitario de Valencia, Hospital Universitario Virgen del Rocío, Hospital Universitario Reina Sofía, Hospital Universitario Fundación Jiménez Díaz, Hospital Universitario Ramón y Cajal, Hospital Regional de Concepción, Hospital Universitario Doctor Peset, Hospital General Universitario de Albacete, Complejo Hospitalario Universitario de Albacete, Hospital Universitario de Gran Canaria Doctor Negrín, Foscal Hospital, Hospital Universitario de Burgos, Universidad de Burgos, Hospital Universitari Germans Trias i Pujol, Vall d'Hebron Hospital Universitari, Hospital General Universitario Morales Meseguer, Hospital Arnau de Vilanova, Hospital Dr. Gustavo Fricke, Hospital del Salvador, Hospital Clínico Universitario Virgen de la Victoria, Universidad de Salamanca, Complejo Hospitalario de Salamanca, Hospital Clínico San Carlos, Hospital Universitario Virgen Macarena, Clínica Dávila, Complejo Hospitalario de Pontevedra, Hospital Montecelo, Hospital Universitario Puerta de Hierro Majadahonda, Hospital Universitario 12 De Octubre, Hospital Universitario Príncipe de Asturias, Hospital General Universitario De Valencia, Hospital Regional Universitario de Málaga, Hospital General Universitario Gregorio Marañón, Clínica Alemana, Hospital Universitario Nuestra Señora de Candelaria, Hospital Virgen de la Luz, Hospital San Pedro de Alcántara
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $5,450
OpenAlex ID: W7155180204