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...

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Autores: Abrisqueta, Pau, Loscertales, Javier, Terol, María José, Ramírez Payer, Ángel, Ortiz, Macarena, Pérez, Inmaculada, Ríos Herranz, Eduardo, Villanueva, Miguel
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/149210
Acceso en línea:https://hdl.handle.net/11441/149210
https://doi.org/10.1016/j.clml.2021.07.022
Access Level:acceso abierto
Palabra clave:Chronic lymphocytic leukemia (CLL)
Ibrutinib
Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)
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spelling Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study)Abrisqueta, PauLoscertales, JavierTerol, María JoséRamírez Payer, ÁngelOrtiz, MacarenaPérez, InmaculadaRíos Herranz, EduardoVillanueva, MiguelChronic lymphocytic leukemia (CLL)IbrutinibRelapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)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 ibruti-nib 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.Janssen-Cilag S.AElsevierMedicina2021info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/149210https://doi.org/10.1016/j.clml.2021.07.022reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésClinical Lymphoma, Myeloma and Leukemia, 21 (12), e985-e999.info:eu-repo/semantics/openAccessoai:idus.us.es:11441/1492102026-06-17T12:51:07Z
dc.title.none.fl_str_mv Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study)
title Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study)
spellingShingle Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study)
Abrisqueta, Pau
Chronic lymphocytic leukemia (CLL)
Ibrutinib
Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)
title_short Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study)
title_full Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study)
title_fullStr Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study)
title_full_unstemmed Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study)
title_sort Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study)
dc.creator.none.fl_str_mv Abrisqueta, Pau
Loscertales, Javier
Terol, María José
Ramírez Payer, Ángel
Ortiz, Macarena
Pérez, Inmaculada
Ríos Herranz, Eduardo
Villanueva, Miguel
author Abrisqueta, Pau
author_facet Abrisqueta, Pau
Loscertales, Javier
Terol, María José
Ramírez Payer, Ángel
Ortiz, Macarena
Pérez, Inmaculada
Ríos Herranz, Eduardo
Villanueva, Miguel
author_role author
author2 Loscertales, Javier
Terol, María José
Ramírez Payer, Ángel
Ortiz, Macarena
Pérez, Inmaculada
Ríos Herranz, Eduardo
Villanueva, Miguel
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
dc.subject.none.fl_str_mv Chronic lymphocytic leukemia (CLL)
Ibrutinib
Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)
topic Chronic lymphocytic leukemia (CLL)
Ibrutinib
Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)
description 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 ibruti-nib 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.
publishDate 2021
dc.date.none.fl_str_mv 2021
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/149210
https://doi.org/10.1016/j.clml.2021.07.022
url https://hdl.handle.net/11441/149210
https://doi.org/10.1016/j.clml.2021.07.022
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Clinical Lymphoma, Myeloma and Leukemia, 21 (12), e985-e999.
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Elsevier
publisher.none.fl_str_mv Elsevier
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
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collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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