%0 Journal Article
%A Cuneo, Antonio
%A Mato, Anthony R
%A Rigolin, Gian Matteo
%A Piciocchi, Alfonso
%A Gentile, Massimo
%A Laurenti, Luca
%A Allan, John N
%A Pagel, John M
%A Brander, Danielle M
%A Hill, Brian T
%A Winter, Allison
%A Lamanna, Nicole
%A Tam, Constantine S
%A Jacobs, Ryan
%A Lansigan, Frederick
%A Barr, Paul M
%A Shadman, Mazyar
%A Skarbnik, Alan P
%A Pu, Jeffrey J
%A Sehgal, Alison R
%A Schuster, Stephen J
%A Shah, Nirav N
%A Ujjani, Chaitra S
%A Roeker, Lindsey
%A Orlandi, Ester Maria
%A Billio, Atto
%A Trentin, Livio
%A Spacek, Martin
%A Marchetti, Monia
%A Tedeschi, Alessandra
%A Ilariucci, Fiorella
%A Gaidano, Gianluca
%A Doubek, Michael
%A Farina, Lucia
%A Molica, Stefano
%A Di Raimondo, Francesco
%A Coscia, Marta
%A Mauro, Francesca Romana
%A de la Serna, Javier
%A Medina Perez, Angeles
%A Ferrarini, Isacco
%A Cimino, Giuseppe
%A Cavallari, Maurizio
%A Cucci, Rosalba
%A Vignetti, Marco
%A Foà, Robin
%A Ghia, Paolo
%A GIMEMA, European Research Initiative (ERIC) on CLL, US study group
%T Efficacy 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.
%D 2020
%U https://hdl.handle.net/10668/26640
%X Limited 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 
%K bendamustine
%K chronic lymphocytic leukemia
%K ibrutinib
%K real-world analysis
%K unfit patients
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