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

Autor: 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
Přispěvatelé: 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, Ghia, Paolo
Jazyk: angličtina
Rok vydání: 2020
Předmět:
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
Zdroj: Cancer Medicine
Cancer Medicine, Vol 9, Iss 22, Pp 8468-8479 (2020)
Popis: 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.
Databáze: OpenAIRE