%0 Journal Article
%A Abrisqueta, Pau
%A Loscertales, Javier
%A Terol, Maria José
%A Ramírez Payer, Ángel
%A Ortiz, Macarena
%A Pérez, Inmaculada
%A Cuellar-García, Carolina
%A Fernández de la Mata, Margarita
%A Rodríguez, Alicia
%A Lario, Ana
%A Delgado, Julio
%A Godoy, Ana
%A Arguiñano Pérez, José Mª
%A Berruezo, Mª José
%A Oliveira, Ana
%A Hernández-Rivas, José-Ángel
%A García Malo, Maria Dolores
%A Medina, Ángeles
%A García Martin, Paloma
%A Osorio, Santiago
%A Baltasar, Patricia
%A Fernández-Zarzoso, Miguel
%A Marco, Fernando
%A Vidal Manceñido, Mª Jesús
%A Smucler Simonovich, Alicia
%A López Rubio, Montserrat
%A Jarque, Isidro
%A Suarez, Alexia
%A Fernández Álvarez, Rubén
%A Lancharro Anchel, Aima
%A Ríos, Eduardo
%A Losada Castillo, María Del Carmen
%A Pérez Persona, Ernesto
%A García Muñoz, Ricardo
%A Ramos, Rafael
%A Yáñez, Lucrecia
%A Bello, José 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
%U https://hdl.handle.net/10668/25348
%X 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. 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. 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. 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.
%K Chronic lymphocytic leukemia (CLL)
%K Effectiveness
%K First-line
%K Ibrutinib
%K Real-world
%K Relapsed/refractory (R/R)
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