Abrisqueta, PauLoscertales, JavierJose Terol, MariaRamirez Payer, AngelOrtiz, MacarenaPerez, InmaculadaCuellar-Garcia, CarolinaFernandez de la Mata, MargaritaRodriguez, AliciaLario, AnaDelgado, JulioGodoy, AnaArguinano Perez, Jose MaBerruezo, Ma JoseOliveira, AnaHernandez-Rivas, Jose-AngelDolores Garcia Malo, MariaMedina, AngelesGarcia Martin, PalomaOsorio, SantiagoBaltasar, PatriciaFernandez-Zarzoso, MiguelMarco, FernandoVidal Mancenido, Ma JesusSmucler Simonovich, AliciaLopez Rubio, MontserratJarque, IsidroSuarez, AlexiaFernandez Alvarez, RubenLancharro Anchel, AimaRios, EduardoLosada Castillo, Maria del CarmenPerez Persona, ErnestoGarcia Munoz, RicardoRamos, RafaelYanez, LucreciaBello, Jose LuisLoriente, CristinaAcha, DanielVillanueva, Miguel2023-02-122023-02-122021-11-302152-2650http://hdl.handle.net/10668/18742Ibrutinib 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.enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/Chronic lymphocytic leukemia (CLL)EffectivenessFirst-lineIbrutinibReal-worldRelapsed/refractory (R/R)Cll patientsOpen-labelRituximabCyclophosphamideFludarabineChemoimmunotherapyBendamustineEfficacyTherapyPhase-3research articleopen access10.1016/j.clml.2021.07.0222152-2669http://www.clinical-lymphoma-myeloma-leukemia.com/article/S2152265021003037/pdf724142300007