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

Ibrutinib demonstrated robust efficacy, regardless of high-risk features, in previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). The IBRORS-CLL study supports the effectiveness and the manageable safety profile of single-agent ibrutinib, which was not adversely affected b...

ver descrição completa

Detalhes bibliográficos
Autores: Abrisqueta P, Loscertales J, Terol MJ, Ramírez Payer Á, Ortiz M, Pérez I, Cuellar-García C, Fernández de la Mata M, Rodríguez A, Lario A, Delgado J, Godoy A, Arguiñano Pérez JM, Berruezo MJ, Oliveira A, Hernández-Rivas JÁ, García Malo MD, Medina Á, García Martin P, Osorio S, Baltasar P, Fernández-Zarzoso M, Marco F, Vidal Manceñido MJ, Smucler Simonovich A, López Rubio M, Jarque I, Suarez A, Fernández Álvarez R, Lancharro Anchel A, Ríos E, Losada Castillo MDC, Pérez Persona E, García Muñoz R, Ramos R, Yáñez L, Bello JL, Loriente C, Acha D, Villanueva M
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Recursos:Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO)
Repositorio:r-FISABIO. Repositorio Institucional de Producción Científica
OAI Identifier:oai:fisabio.fundanetsuite.com:p10826
Acesso em linha:https://fisabio.portalinvestigacion.com/publicaciones/10826
Access Level:acceso abierto
Palavra-chave:Chronic lymphocytic leukemia (CLL)
Effectiveness
First-line
Ibrutinib
Real-world
Relapsed/refractory (R/R)
Descrição
Resumo:Ibrutinib demonstrated robust efficacy, regardless of high-risk features, in previously untreated or relapsed/refractory chronic lymphocytic leukemia (CLL). The IBRORS-CLL study supports the effectiveness and the manageable safety profile of single-agent ibrutinib, which was not adversely affected by high-risk characteristics in real-world CLL patients in Spain. We also found a high molecular testing rate of del(17p)/TP53 mutation and IGHV mutation status. 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 (122%) 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. (C) 2021 The Author(s). Published by Elsevier Inc.

Registos relacionados