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.
(Journal Article;Multicenter Study)
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) <70 mL/min and/or CIRS score >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 < 0.01) and treatment with ibrutinib (HR 0.55, 95% CI 0.33-0.93, P = 0.03). In a post hoc analysis of patients in advanced stage, a significant PFS advantage was observed in patient who had received ibrutinib (P = 0.03), who showed a trend for OS advantage (P = 0.08). We arrived at the following conclusions: (a) BR is a relatively effective first-line regimen in a real-world population of unfit patients without TP53 disruption, (b) ibrutinib provided longer disease control than BR in patients with advanced disease stage.
Cuneo, A; Mato, AR; Rigolin, GM; Piciocchi, A; Gentile, M; Laurenti, L; Allan, JN; Pagel, JM; Brander, DM; Hill, BT; Winter, A; Lamanna, N; Tam, CS; Jacobs, R; Lansigan, F; Barr, PM; Shadman, M; Skarbnik, AP; Pu, JJ; Sehgal, AR; Schuster, SJ; Shah, NN; Ujjani, CS; Roeker, L; Orlandi, EM; Billio, A; Trentin, L; Spacek, M; Marchetti, M; Tedeschi, A; Ilariucci, F; Gaidano, G; Doubek, M; Farina, L; Molica, S; Di Raimondo, F; Coscia, M; Mauro, FR; de la Serna, J; Medina Perez, A; Ferrarini, I; Cimino, G; Cavallari, M; Cucci, R; Vignetti, M; Foà, R; Ghia, P; GIMEMA, European Research Initiative (ERIC) on CLL, US study group,
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