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: Cancer Medicine

A. Cuneo, A.R. Mato, G.M. Rigolin, A. Piciocchi, M. Gentile, L. Laurenti, J.N. Allan, J.M. Pagel, D.M. Brander, B.T. Hill, A. Winter, N. Lamanna, C.S. Tam, R. Jacobs, F. Lansigan, P.M. Barr, M. Shadman, A.P. Skarbnik, J.J. Pu, A.R. SehgalS.J. Schuster, N.N. Shah, C.S. Ujjani, L. Roeker, E.M. Orlandi, A. Billio, L. Trentin, M. Spacek, M. Marchetti, A. Tedeschi, F. Ilariucci, G. Gaidano, M. Doubek, L. Farina, S. Molica, F. Di Raimondo, M. Coscia, F.R. Mauro, J. de la Serna, A. Medina Perez, I. Ferrarini, G. Cimino, M. Cavallari, R. Cucci, M. Vignetti, R. Foà, P. Ghia, US study group the GIMEMA European Research Initiative (ERIC) on CLL

Research output: Contribution to journalArticlepeer-review

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) 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 
Original languageEnglish
Pages (from-to)8468-8479
Number of pages12
JournalCancer Med.
Volume9
Issue number22
DOIs
Publication statusPublished - 2020

Keywords

  • bendamustine
  • chronic lymphocytic leukemia
  • ibrutinib
  • real-world analysis
  • unfit patients
  • protein p53
  • rituximab
  • adult
  • advanced cancer
  • aged
  • aging
  • Article
  • chronic lymphatic leukemia
  • comorbidity
  • creatinine clearance
  • cytopenia
  • dermatitis
  • drug dose reduction
  • drug efficacy
  • febrile neutropenia
  • female
  • human
  • infection
  • major clinical study
  • male
  • mortality risk
  • neutropenia
  • overall survival
  • priority journal
  • progression free survival
  • rash
  • retrospective study
  • risk factor
  • TP53 gene
  • very elderly

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