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 Jose Terol, Maria
A1 Ramirez Payer, Angel
A1 Ortiz, Macarena
A1 Perez, Inmaculada
A1 Cuellar-Garcia, Carolina
A1 Fernandez de la Mata, Margarita
A1 Rodriguez, Alicia
A1 Lario, Ana
A1 Delgado, Julio
A1 Godoy, Ana
A1 Arguinano Perez, Jose Ma
A1 Berruezo, Ma Jose
A1 Oliveira, Ana
A1 Hernandez-Rivas, Jose-Angel
A1 Dolores Garcia Malo, Maria
A1 Medina, Angeles
A1 Garcia Martin, Paloma
A1 Osorio, Santiago
A1 Baltasar, Patricia
A1 Fernandez-Zarzoso, Miguel
A1 Marco, Fernando
A1 Vidal Mancenido, Ma Jesus
A1 Smucler Simonovich, Alicia
A1 Lopez Rubio, Montserrat
A1 Jarque, Isidro
A1 Suarez, Alexia
A1 Fernandez Alvarez, Ruben
A1 Lancharro Anchel, Aima
A1 Rios, Eduardo
A1 Losada Castillo, Maria del Carmen
A1 Perez Persona, Ernesto
A1 Garcia Munoz, Ricardo
A1 Ramos, Rafael
A1 Yanez, Lucrecia
A1 Bello, Jose 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)
K1 Cll patients
K1 Open-label
K1 Rituximab
K1 Cyclophosphamide
K1 Fludarabine
K1 Chemoimmunotherapy
K1 Bendamustine
K1 Efficacy
K1 Therapy
K1 Phase-3
AB 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.
PB Cig media group, lp
SN 2152-2650
YR 2021
FD 2021-11-30
LK http://hdl.handle.net/10668/18742
UL http://hdl.handle.net/10668/18742
LA en
DS RISalud
RD Apr 5, 2025