Abrisqueta, PauLoscertales, JavierTerol, Maria JoséRamírez Payer, ÁngelOrtiz, MacarenaPérez, InmaculadaCuellar-García, CarolinaFernández de la Mata, MargaritaRodríguez, AliciaLario, AnaDelgado, JulioGodoy, AnaArguiñano Pérez, José MªBerruezo, Mª JoséOliveira, AnaHernández-Rivas, José-ÁngelGarcía Malo, Maria DoloresMedina, ÁngelesGarcía Martin, PalomaOsorio, SantiagoBaltasar, PatriciaFernández-Zarzoso, MiguelMarco, FernandoVidal Manceñido, Mª JesúsSmucler Simonovich, AliciaLópez Rubio, MontserratJarque, IsidroSuarez, AlexiaFernández Álvarez, RubénLancharro Anchel, AimaRíos, EduardoLosada Castillo, María Del CarmenPérez Persona, ErnestoGarcía Muñoz, RicardoRamos, RafaelYáñez, LucreciaBello, José LuisLoriente, CristinaAcha, DanielVillanueva, Miguel2025-01-072025-01-072021-08-03https://hdl.handle.net/10668/25348Ibrutinib 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.enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/Chronic lymphocytic leukemia (CLL)EffectivenessFirst-lineIbrutinibReal-worldRelapsed/refractory (R/R)AdenineAgedHumansLeukemia, Lymphocytic, Chronic, B-CellPiperidinesPyrazolesPyrimidinesRetrospective StudiesSpainresearch article34511320open access10.1016/j.clml.2021.07.0222152-2669http://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152265021003037/pdf