Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study).

BACKGROUND: Ibrutinib demonstrated remarkable efficacy and favorable tolerability in patients with untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), including those with high-risk genetic alterations. The IBRORS-CLL study assessed the characteristics, clinical management and...

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Detalles Bibliográficos
Autores: Abrisqueta, Pau, Loscertales, Javier, Terol, Maria Jose, Ramirez Payer, Angel, Ortiz, Macarena, Perez, Inmaculada, Cuellar-Garcia, Carolina, Fernandez de la Mata, Margarita, Rodriguez, Alicia, Lario, Ana, Delgado, Julio, Godoy, Ana, Arguinano Perez, Jose M, Berruezo, M Jose, Oliveira, Ana, Hernandez-Rivas, Jose-Angel, Garcia Malo, Maria Dolores, Medina, Angeles, Garcia Martin, Paloma, Osorio, Santiago, Baltasar, Patricia, Fernandez-Zarzoso, Miguel, Marco, Fernando, Vidal Mancenido, M Jesus, Smucler Simonovich, Alicia, Lopez Rubio, Montserrat, Jarque, Isidro, Suarez, Alexia, Fernandez Alvarez, Ruben, Lancharro Anchel, Aima, Rios, Eduardo, Losada Castillo, Maria Del Carmen, Perez Persona, Ernesto, Garcia Munoz, Ricardo, Ramos, Rafael, Yanez, Lucrecia, Bello, Jose Luis, Loriente, Cristina, Acha, Daniel, Villanueva, Miguel
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p15987
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/15987
Access Level:acceso abierto
Palabra clave:Chronic lymphocytic leukemia (CLL)
Effectiveness
First-line
Ibrutinib
Real-world
Relapsed/refractory (R/R)
Descripción
Sumario:BACKGROUND: Ibrutinib demonstrated remarkable efficacy and favorable tolerability in patients with untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), including those with high-risk genetic alterations. The IBRORS-CLL study assessed the characteristics, clinical management and outcome of CLL patients receiving ibrutinib in routine clinical practice in Spain. PATIENTS: Observational, retrospective, multicenter study in CLL patients who started single-agent ibrutinib as first-line treatment or at first or second relapse between January 2016 and January 2019. RESULTS: A total of 269 patients were included (median age: 70.9 years; cardiovascular comorbidity: 55.4%, including hypertension [47.6%] and atrial fibrillation [AF] [7.1%]). Overall, 96.7% and 69% of patients underwent molecular testing for del(17p)/TP53 mutation and IGHV mutation status. High-risk genetic features included unmutated IGHV (79%) and del(17p)/TP53 mutation (first-line: 66.3%; second-line: 23.1%). Overall, 84 (31.2%) patients received ibrutinib as first-line treatment, and it was used as second- and third-line therapy in 121 (45.0%) and 64 (23.8%) patients. The median progression-free survival and overall survival were not reached irrespective of del(17p)/TP53, or unmutated IGHV. Common grade =3 adverse events were infections (12.2%) and bleeding (3%). Grade =3 AF occurred in 1.5% of patients. CONCLUSION: This real-world study shows that single-agent ibrutinib is an effective therapy for CLL, regardless of age and high-risk molecular features, consistent with clinical trials. Additionally, single-agent ibrutinib was well tolerated, with a low rate of cardiovascular events. This study also emphasized a high molecular testing rate of del(17p)/TP53 mutation and IGHV mutation status in clinical practice according to guideline recommendations.

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