Cuneo, AntonioMato, Anthony RRigolin, Gian MatteoPiciocchi, AlfonsoGentile, MassimoLaurenti, LucaAllan, John NPagel, John MBrander, Danielle MHill, Brian TWinter, AllisonLamanna, NicoleTam, Constantine SJacobs, RyanLansigan, FrederickBarr, Paul MShadman, MazyarSkarbnik, Alan PPu, Jeffrey JSehgal, Alison RSchuster, Stephen JShah, Nirav NUjjani, Chaitra SRoeker, LindseyOrlandi, Ester MariaBillio, AttoTrentin, LivioSpacek, MartinMarchetti, MoniaTedeschi, AlessandraIlariucci, FiorellaGaidano, GianlucaDoubek, MichaelFarina, LuciaMolica, StefanoDi Raimondo, FrancescoCoscia, MartaMauro, Francesca Romanade la Serna, JavierMedina Perez, AngelesFerrarini, IsaccoCimino, GiuseppeCavallari, MaurizioCucci, RosalbaVignetti, MarcoFoà, RobinGhia, PaoloGIMEMA, European Research Initiative (ERIC) on CLL, US study group2025-01-072025-01-072020-09-24https://hdl.handle.net/10668/26640Limited information is available on the efficacy of front-line bendamustine and rituximab (BR) in chronic lymphocytic leukemia (CLL) with reduced renal function or coexisting conditions. We therefore analyzed a cohort of real-world patients and performed a matched adjusted indirect comparison with a cohort of patients treated with ibrutinib. One hundred and fifty-seven patients with creatinine clearance (CrCl) 6 were treated with BR. The median age was 72 years; 69% of patients had ≥2 comorbidities and the median CrCl was 59.8 mL/min. 17.6% of patients carried TP53 disruption. The median progression-free survival (PFS) was 45 months; TP53 disruption was associated with a shorter PFS (P = 0.05). The overall survival (OS) at 12, 24, and 36 months was 96.2%, 90.1%, and 79.5%, respectively. TP53 disruption was associated with an increased risk of death (P = 0.01). Data on 162 patients ≥65 years treated with ibrutinib were analyzed and compared with 165 patients ≥65 years treated with BR. Factors predicting for a longer PFS at multivariable analysis in the total patient population treated with BR and ibrutinib were age (HR 1.06, 95% CI 1.02-1.10, P enAttribution 4.0 Internationalhttp://creativecommons.org/licenses/by/4.0/bendamustinechronic lymphocytic leukemiaibrutinibreal-world analysisunfit patientsAdenineAgedAntineoplastic Agents, AlkylatingAntineoplastic Agents, ImmunologicalAntineoplastic Combined Chemotherapy ProtocolsBendamustine HydrochlorideDisease ProgressionEuropeFemaleHumansLeukemia, Lymphocytic, Chronic, B-CellMaleMiddle AgedPiperidinesProgression-Free SurvivalProtein Kinase InhibitorsRetrospective StudiesRituximabTime FactorsUnited StatesEfficacy of bendamustine and rituximab in unfit patients with previously untreated chronic lymphocytic leukemia. Indirect comparison with ibrutinib in a real-world setting. A GIMEMA-ERIC and US study.research article32969597open access10.1002/cam4.34702045-7634PMC7666748https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/cam4.3470https://pmc.ncbi.nlm.nih.gov/articles/PMC7666748/pdf