RT Journal Article
T1 Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study).
A1 Abrisqueta, Pau
A1 Loscertales, Javier
A1 Terol, Maria José
A1 Ramírez Payer, Ángel
A1 Ortiz, Macarena
A1 Pérez, Inmaculada
A1 Cuellar-García, Carolina
A1 Fernández de la Mata, Margarita
A1 Rodríguez, Alicia
A1 Lario, Ana
A1 Delgado, Julio
A1 Godoy, Ana
A1 Arguiñano Pérez, José Mª
A1 Berruezo, Mª José
A1 Oliveira, Ana
A1 Hernández-Rivas, José-Ángel
A1 García Malo, Maria Dolores
A1 Medina, Ángeles
A1 García Martin, Paloma
A1 Osorio, Santiago
A1 Baltasar, Patricia
A1 Fernández-Zarzoso, Miguel
A1 Marco, Fernando
A1 Vidal Manceñido, Mª Jesús
A1 Smucler Simonovich, Alicia
A1 López Rubio, Montserrat
A1 Jarque, Isidro
A1 Suarez, Alexia
A1 Fernández Álvarez, Rubén
A1 Lancharro Anchel, Aima
A1 Ríos, Eduardo
A1 Losada Castillo, María Del Carmen
A1 Pérez Persona, Ernesto
A1 García Muñoz, Ricardo
A1 Ramos, Rafael
A1 Yáñez, Lucrecia
A1 Bello, José Luis
A1 Loriente, Cristina
A1 Acha, Daniel
A1 Villanueva, Miguel
K1 Chronic lymphocytic leukemia (CLL)
K1 Effectiveness
K1 First-line
K1 Ibrutinib
K1 Real-world
K1 Relapsed/refractory (R/R)
AB 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.
YR 2021
FD 2021-08-03
LK https://hdl.handle.net/10668/25348
UL https://hdl.handle.net/10668/25348
LA en
DS RISalud
RD Apr 17, 2025