%0 Journal Article
%A Abrisqueta, Pau
%A Loscertales, Javier
%A Jose Terol, Maria
%A Ramirez Payer, Angel
%A Ortiz, Macarena
%A Perez, Inmaculada
%A Cuellar-Garcia, Carolina
%A Fernandez de la Mata, Margarita
%A Rodriguez, Alicia
%A Lario, Ana
%A Delgado, Julio
%A Godoy, Ana
%A Arguinano Perez, Jose Ma
%A Berruezo, Ma Jose
%A Oliveira, Ana
%A Hernandez-Rivas, Jose-Angel
%A Dolores Garcia Malo, Maria
%A Medina, Angeles
%A Garcia Martin, Paloma
%A Osorio, Santiago
%A Baltasar, Patricia
%A Fernandez-Zarzoso, Miguel
%A Marco, Fernando
%A Vidal Mancenido, Ma Jesus
%A Smucler Simonovich, Alicia
%A Lopez Rubio, Montserrat
%A Jarque, Isidro
%A Suarez, Alexia
%A Fernandez Alvarez, Ruben
%A Lancharro Anchel, Aima
%A Rios, Eduardo
%A Losada Castillo, Maria del Carmen
%A Perez Persona, Ernesto
%A Garcia Munoz, Ricardo
%A Ramos, Rafael
%A Yanez, Lucrecia
%A Bello, Jose Luis
%A Loriente, Cristina
%A Acha, Daniel
%A Villanueva, Miguel
%T Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study)
%D 2021
%@ 2152-2650
%U http://hdl.handle.net/10668/18742
%X 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.
%K Chronic lymphocytic leukemia (CLL)
%K Effectiveness
%K First-line
%K Ibrutinib
%K Real-world
%K Relapsed/refractory (R/R)
%K Cll patients
%K Open-label
%K Rituximab
%K Cyclophosphamide
%K Fludarabine
%K Chemoimmunotherapy
%K Bendamustine
%K Efficacy
%K Therapy
%K Phase-3
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