1. 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.
- Author
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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, and Ghia P
- Subjects
- Adenine adverse effects, Adenine therapeutic use, Aged, Antineoplastic Agents, Alkylating adverse effects, Antineoplastic Agents, Immunological adverse effects, Antineoplastic Combined Chemotherapy Protocols adverse effects, Bendamustine Hydrochloride adverse effects, Disease Progression, Europe, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell diagnosis, Leukemia, Lymphocytic, Chronic, B-Cell mortality, Male, Middle Aged, Piperidines adverse effects, Progression-Free Survival, Protein Kinase Inhibitors adverse effects, Retrospective Studies, Rituximab adverse effects, Time Factors, United States, Adenine analogs & derivatives, Antineoplastic Agents, Alkylating therapeutic use, Antineoplastic Agents, Immunological therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Bendamustine Hydrochloride therapeutic use, Leukemia, Lymphocytic, Chronic, B-Cell drug therapy, Piperidines therapeutic use, Protein Kinase Inhibitors therapeutic use, Rituximab therapeutic use
- Abstract
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., (© 2020 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)
- Published
- 2020
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