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

Luca Laurenti, Marino Gentile, Atto Billio, Alessandra Tedeschi, Serena Molica, Giovanni Cimino, Maurizio Cavallari, Robin Foa, Antonio Cuneo, Anthony R. Mato, Gian Matteo Rigolin, Alfonso Piciocchi, Massimo Gentile, John N. Allan, John M. Pagel, Danielle M. Brander, Brian T. Hill, Allison Winter, Nicole Lamanna, Constantine S. TamRyan Jacobs, Frederick Lansigan, Paul M. Barr, Mazyar Shadman, Alan P. Skarbnik, Jeffrey J. Pu, Alison R. Sehgal, Stephen J. Schuster, Nirav N. Shah, Chaitra S. Ujjani, Lindsey Roeker, Ester Maria Orlandi, Livio Trentin, Martin Spacek, Monia Marchetti, Fiorella Ilariucci, Gianluca Gaidano, Michael Doubek, Lucia Farina, Stefano Molica, Francesco Di Raimondo, Marta Coscia, Francesca Romana Mauro, Javier De La Serna, Angeles Medina Perez, Isacco Ferrarini, Giuseppe Cimino, Rosalba Cucci, Marco Vignetti, Robin Foà, Paolo Ghia

Risultato della ricerca: Contributo in rivistaArticolo in rivista

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.
Lingua originaleEnglish
pagine (da-a)8468-8479
Numero di pagine12
RivistaCancer Medicine
Volume9
DOI
Stato di pubblicazionePubblicato - 2020

Keywords

  • Adenine
  • Aged
  • Antineoplastic Agents, Alkylating
  • Antineoplastic Agents, Immunological
  • Antineoplastic Combined Chemotherapy Protocols
  • Bendamustine Hydrochloride
  • Disease Progression
  • Europe
  • Female
  • Humans
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Male
  • Middle Aged
  • Piperidines
  • Progression-Free Survival
  • Protein Kinase Inhibitors
  • Retrospective Studies
  • Rituximab
  • Time Factors
  • United States
  • bendamustine
  • chronic lymphocytic leukemia
  • ibrutinib
  • real-world analysis
  • unfit patients

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