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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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, Cuneo, Antonio, Mato, Anthony R, Rigolin, Gian Matteo, Piciocchi, Alfonso, Gentile, Massimo, Laurenti, Luca, Allan, John N, Pagel, John M, Brander, Danielle M, Hill, Brian T, Winter, Allison, Lamanna, Nicole, Tam, Constantine S, Jacobs, Ryan, Lansigan, Frederick, Barr, Paul M, Shadman, Mazyar, Skarbnik, Alan P, Pu, Jeffrey J, Sehgal, Alison R, Schuster, Stephen J, Shah, Nirav N, Ujjani, Chaitra S, Roeker, Lindsey, Orlandi, Ester Maria, Billio, Atto, Trentin, Livio, Spacek, Martin, Marchetti, Monia, Tedeschi, Alessandra, Ilariucci, Fiorella, Gaidano, Gianluca, Doubek, Michael, Farina, Lucia, Molica, Stefano, Di Raimondo, Francesco, Coscia, Marta, Mauro, Francesca Romana, de la Serna, Javier, Medina Perez, Angele, Ferrarini, Isacco, Cimino, Giuseppe, Cavallari, Maurizio, Cucci, Rosalba, Vignetti, Marco, Foà, Robin, and Ghia, Paolo
- Subjects
0301 basic medicine ,Male ,Cancer Research ,Time Factors ,bendamustine ,chronic lymphocytic leukemia ,ibrutinib ,real-world analysis ,unfit patients ,Gastroenterology ,chemistry.chemical_compound ,0302 clinical medicine ,Antineoplastic Agents, Immunological ,Piperidines ,Antineoplastic Combined Chemotherapy Protocols ,Medicine ,Bendamustine Hydrochloride ,Chronic ,Original Research ,education.field_of_study ,Leukemia ,chronic lymphocytic leukemia, bendamustine, ibrutinib, real-world analysis, unfit patients ,Middle Aged ,lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,Alkylating ,Progression-Free Survival ,Lymphocytic ,Europe ,Immunological ,Oncology ,030220 oncology & carcinogenesis ,Ibrutinib ,Disease Progression ,Rituximab ,Female ,Untreated Chronic Lymphocytic Leukemia ,medicine.drug ,Bendamustine ,medicine.medical_specialty ,Population ,Antineoplastic Agents ,lcsh:RC254-282 ,NO ,03 medical and health sciences ,real‐world analysis ,Internal medicine ,Humans ,Radiology, Nuclear Medicine and imaging ,Progression-free survival ,education ,Antineoplastic Agents, Alkylating ,Protein Kinase Inhibitors ,Aged ,Retrospective Studies ,business.industry ,Adenine ,B-Cell ,Clinical Cancer Research ,medicine.disease ,Leukemia, Lymphocytic, Chronic, B-Cell ,United States ,Regimen ,Settore MED/15 - MALATTIE DEL SANGUE ,030104 developmental biology ,chemistry ,business ,Febrile neutropenia - 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, Bendamustine and Rituximab was a relatively effective first‐line regimen in real‐world untreated CLL patients with reduced renal function or coexisting conditions without TP53 disruption.In a matched‐adjusted indirect comparison with a cohort of CLL patients treated upfront, ibrutinib provided longer PFS than bendamustine and rituximab in those with advanced stage.
- Published
- 2020