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
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 comparis...
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Format: | Article |
Language: | English |
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Wiley
2020-11-01
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Series: | Cancer Medicine |
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Online Access: | https://doi.org/10.1002/cam4.3470 |
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language |
English |
format |
Article |
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DOAJ |
author |
Antonio Cuneo Anthony R. Mato Gian Matteo Rigolin Alfonso Piciocchi Massimo Gentile Luca Laurenti John N. Allan John M. Pagel Danielle M. Brander Brian T. Hill Allison Winter Nicole Lamanna Constantine S. Tam Ryan 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 Atto Billio Livio Trentin Martin Spacek Monia Marchetti Alessandra Tedeschi 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 Maurizio Cavallari Rosalba Cucci Marco Vignetti Robin Foà Paolo Ghia the GIMEMA, European Research Initiative (ERIC) on CLL, US study group |
spellingShingle |
Antonio Cuneo Anthony R. Mato Gian Matteo Rigolin Alfonso Piciocchi Massimo Gentile Luca Laurenti John N. Allan John M. Pagel Danielle M. Brander Brian T. Hill Allison Winter Nicole Lamanna Constantine S. Tam Ryan 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 Atto Billio Livio Trentin Martin Spacek Monia Marchetti Alessandra Tedeschi 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 Maurizio Cavallari Rosalba Cucci Marco Vignetti Robin Foà Paolo Ghia the GIMEMA, European Research Initiative (ERIC) on CLL, US study group 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 bendamustine chronic lymphocytic leukemia ibrutinib real‐world analysis unfit patients |
author_facet |
Antonio Cuneo Anthony R. Mato Gian Matteo Rigolin Alfonso Piciocchi Massimo Gentile Luca Laurenti John N. Allan John M. Pagel Danielle M. Brander Brian T. Hill Allison Winter Nicole Lamanna Constantine S. Tam Ryan 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 Atto Billio Livio Trentin Martin Spacek Monia Marchetti Alessandra Tedeschi 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 Maurizio Cavallari Rosalba Cucci Marco Vignetti Robin Foà Paolo Ghia the GIMEMA, European Research Initiative (ERIC) on CLL, US study group |
author_sort |
Antonio Cuneo |
title |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
Wiley |
series |
Cancer Medicine |
issn |
2045-7634 |
publishDate |
2020-11-01 |
description |
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. |
topic |
bendamustine chronic lymphocytic leukemia ibrutinib real‐world analysis unfit patients |
url |
https://doi.org/10.1002/cam4.3470 |
work_keys_str_mv |
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doaj-51d4f3af2edb4e18930e0b7ba14d8eff2020-11-25T04:02:07ZengWileyCancer Medicine2045-76342020-11-019228468847910.1002/cam4.3470Efficacy 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 studyAntonio Cuneo0Anthony R. Mato1Gian Matteo Rigolin2Alfonso Piciocchi3Massimo Gentile4Luca Laurenti5John N. Allan6John M. Pagel7Danielle M. Brander8Brian T. Hill9Allison Winter10Nicole Lamanna11Constantine S. Tam12Ryan Jacobs13Frederick Lansigan14Paul M. Barr15Mazyar Shadman16Alan P. Skarbnik17Jeffrey J. Pu18Alison R. Sehgal19Stephen J. Schuster20Nirav N. Shah21Chaitra S. Ujjani22Lindsey Roeker23Ester Maria Orlandi24Atto Billio25Livio Trentin26Martin Spacek27Monia Marchetti28Alessandra Tedeschi29Fiorella Ilariucci30Gianluca Gaidano31Michael Doubek32Lucia Farina33Stefano Molica34Francesco Di Raimondo35Marta Coscia36Francesca Romana Mauro37Javier de la Serna38Angeles Medina Perez39Isacco Ferrarini40Giuseppe Cimino41Maurizio Cavallari42Rosalba Cucci43Marco Vignetti44Robin Foà45Paolo Ghia46the GIMEMA, European Research Initiative (ERIC) on CLL, US study groupHematology Department of Medical Sciences St. Anna University Hospital Ferrara ItalyDivision of Hematological Oncology CLL ProgramMemorial Sloan Kettering Cancer Center New York NY USAHematology Department of Medical Sciences St. Anna University Hospital Ferrara ItalyItalian Group for Adult Hematologic Diseases (GIMEMA) Data Center and Health Outcomes Research Unit Rome ItalyDepartment of Onco‐Hematology Hematology UnitA.O. of Cosenza Cosenza ItalyDepartment of Radiological, Radiotherapeutic and Hematological Sciences Fondazione Policlinico Universitario “A. Gemelli” IRCCS Rome ItalyWeill Cornell Medicine New York NY USACenter for Blood Disorders and Stem Cell Transplantation Swedish Cancer Institute Seattle WA USADivision of Hematologic Malignancies and Cellular Therapy Duke University Durham NC USATaussig Cancer InstituteCleveland Clinic Cleveland OH USATaussig Cancer InstituteCleveland Clinic Cleveland OH USAColumbia University Medical Center New York NY USAPeter McCallum Cancer Centre University of Melbourne Melbourne Victoria AustraliaDepartment of Hematologic Oncology and Blood Disorders Levine Cancer InstituteCarolinas Healthcare System Charlotte NC USADartmouth‐Hitchcock Medical Center Lebanon NH USAWilmot Cancer InstituteUniversity of Rochester Medical Center Rochester NY USAFred Hutchinson Cancer Research CenterSeattle Cancer Care Alliance Seattle WA USALymphoproliferative Disorders Program Novant Health Cancer Institute Charlotte NC USASUNY Upstate Medical UniversitySUNY Upstate Medical University Syracuse NY USAUniversity of Pittsburgh Pittsburgh PA USADivision of Hematology and Oncology University of Pennsylvania Philadelphia PA USADivision of Hematology & Oncology Medical College of Wisconsin Milwaukee WI USAFred Hutchinson Cancer Research CenterSeattle Cancer Care Alliance Seattle WA USADivision of Hematological Oncology CLL ProgramMemorial Sloan Kettering Cancer Center New York NY USAHematology UnitIRCCS Policlinico San Matteo Pavia ItalyHematology and Transplant Unit San Maurizio HospitalAzienda Sanitaria dell'Alto Adige Bolzano ItalyHematology and Clinical Immunology Department of Medicine University of Padua Padua ItalyDepartment of Medicine Department of Hematology First Faculty of Medicine Charles University and General University Hospital Prague Czech RepublicOncology UnitCardinal Massaia Hospital Asti ItalyHematology Niguarda Cancer CenterASST Grande Ospedale Metropolitano Niguarda Milan ItalyHematology Azienda USL‐IRCCS Reggio Emilia ItalyDivision of Hematology Department of Translational Medicine University of eastern Piedmont Novara ItalyDepartment of Internal Medicine ‐ Hematology and Oncology University Hospital Brno and Faculty of MedicineMasaryk University Brno Czech RepublicHematology Department Fondazione IRCCS Istituto Nazionale Tumori Milano ItalyHematology Unit A. Pugliese HospitalAzienda Ospedaliera Pugliese Ciaccio Catanzaro ItalyCatania Università di CataniaCattedra di Ematologia Catania ItalyDivision of Hematology A.O.U. Città della Salute e della Scienza di Torino and Department of Molecular Biotechnology and Health Sciences University of Torino Torino ItalyHematology Department of Translational and Precision Medicine "Sapienza" University Rome ItalyHematology Unit Hospital Universitario Madrid SpainHospital Costa del Sol Marbella SpainHematology Department of Cell Therapy and Hematology University Hospital Verona ItalyDepartment of Translational and Precision Medicine University “La Sapienza”UOC di Ematologia con TrapiantoOspedale S. Maria Goretti Latina ItalyHematology Department of Medical Sciences St. Anna University Hospital Ferrara ItalyItalian Group for Adult Hematologic Diseases (GIMEMA) Data Center and Health Outcomes Research Unit Rome ItalyItalian Group for Adult Hematologic Diseases (GIMEMA) Data Center and Health Outcomes Research Unit Rome ItalyHematology Department of Translational and Precision Medicine "Sapienza" University Rome ItalyStrategic Research Program on CLL Division of Experimental Oncology IRCCS Ospedale San RaffaeleUniversità Vita‐Salute San Raffaele Milan ItalyAbstract 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.https://doi.org/10.1002/cam4.3470bendamustinechronic lymphocytic leukemiaibrutinibreal‐world analysisunfit patients |