Venetoclax-based regimens in octogenarian patients with CLL: efficacy, safety, and comparison to BTKi in a multicenter cohort

Abstract: Octogenarians represent a significant fraction of patients with chronic lymphocytic leukemia (CLL) but, despite the prevalence of the disease in this age group, limited data are available on the safety and efficacy of novel drugs in this subgroup. We conducted a multicenter retrospective s...

Full description

Saved in:
Bibliographic Details
Main Authors: Andrea Serafin, Alessandro Cellini, Enrica Antonia Martino, Federica Mazzetto, Francesco Angotzi, Anna Maria Frustaci, Monia Marchetti, Riccardo Moia, Alessandro Sanna, Costantino Riemma, Francesca Cibien, Alessandro Noto, Enrico Lista, Myriam Foglietta, Candida Vitale, Vanessa Innao, Martina Bullo, Ester Lovato, Isacco Ferrarini, Costanza Andriola, Laura Ballotta, Idanna Innocenti, Alberto Fresa, Gianmarco Favrin, Marzia Varettoni, Elisa Santambrogio, Lorella Orsucci, Raffaella Pasquale, Massimo Moratti, Luca Laurenti, Marta Coscia, Paolo Sportoletti, Roberto Marasca, Francesca Romana Mauro, Caterina Patti, Enrico Derenzini, Lydia Scarfò, Paolo Ghia, Antonio Cuneo, Alessandra Tedeschi, Livio Trentin, Massimo Gentile, Andrea Visentin
Format: Article
Language:English
Published: Elsevier 2025-07-01
Series:Blood Advances
Online Access:http://www.sciencedirect.com/science/article/pii/S2473952925002277
Tags: Add Tag
No Tags, Be the first to tag this record!
_version_ 1849716662932078592
author Andrea Serafin
Alessandro Cellini
Enrica Antonia Martino
Federica Mazzetto
Francesco Angotzi
Anna Maria Frustaci
Monia Marchetti
Riccardo Moia
Alessandro Sanna
Costantino Riemma
Francesca Cibien
Alessandro Noto
Enrico Lista
Myriam Foglietta
Candida Vitale
Vanessa Innao
Martina Bullo
Ester Lovato
Isacco Ferrarini
Costanza Andriola
Laura Ballotta
Idanna Innocenti
Alberto Fresa
Gianmarco Favrin
Marzia Varettoni
Elisa Santambrogio
Lorella Orsucci
Raffaella Pasquale
Massimo Moratti
Luca Laurenti
Marta Coscia
Paolo Sportoletti
Roberto Marasca
Francesca Romana Mauro
Caterina Patti
Enrico Derenzini
Lydia Scarfò
Paolo Ghia
Antonio Cuneo
Alessandra Tedeschi
Livio Trentin
Massimo Gentile
Andrea Visentin
author_facet Andrea Serafin
Alessandro Cellini
Enrica Antonia Martino
Federica Mazzetto
Francesco Angotzi
Anna Maria Frustaci
Monia Marchetti
Riccardo Moia
Alessandro Sanna
Costantino Riemma
Francesca Cibien
Alessandro Noto
Enrico Lista
Myriam Foglietta
Candida Vitale
Vanessa Innao
Martina Bullo
Ester Lovato
Isacco Ferrarini
Costanza Andriola
Laura Ballotta
Idanna Innocenti
Alberto Fresa
Gianmarco Favrin
Marzia Varettoni
Elisa Santambrogio
Lorella Orsucci
Raffaella Pasquale
Massimo Moratti
Luca Laurenti
Marta Coscia
Paolo Sportoletti
Roberto Marasca
Francesca Romana Mauro
Caterina Patti
Enrico Derenzini
Lydia Scarfò
Paolo Ghia
Antonio Cuneo
Alessandra Tedeschi
Livio Trentin
Massimo Gentile
Andrea Visentin
author_sort Andrea Serafin
collection DOAJ
description Abstract: Octogenarians represent a significant fraction of patients with chronic lymphocytic leukemia (CLL) but, despite the prevalence of the disease in this age group, limited data are available on the safety and efficacy of novel drugs in this subgroup. We conducted a multicenter retrospective study enrolling 120 octogenarian patients who received venetoclax (Ven) regimens in any line. Regarding efficacy, we found Ven to perform similarly to what is reported in younger patients with CLL, with an overall response rate of 91%, a complete response rate of 44%, and median progression-free survival of 44 months. Concerning safety, we report a toxicity profile that is consistent with previous reports, with most high-grade adverse events being of hematologic or infectious nature, given that 37% and 22% of patients experienced neutropenia or infections of grade 3 or higher. As part of our study, we compared the safety and efficacy data we collected with those obtained in a comparable Bruton tyrosine kinase inhibitor (BTKi)-treated population. We found that these 2 treatments were comparable in terms of overall efficacy, barring a higher rate of complete responses with Ven; safety profiles were different among the 2 groups given that BTKi-treated patients had more cardiovascular toxicities (26% vs 4%) and Ven-treated subjects experienced more infectious events (82% vs 49%). Our data point out that Ven-based regimens are safe and effective in octogenarian patients with CLL despite their higher clinical complexity and comorbidity burden and should provide some basis for the design of prospective studies to further evaluate the optimal treatment regimen in this patient population.
format Article
id doaj-art-e9e71539d7b242a58b4b45e5be57cc35
institution DOAJ
issn 2473-9529
language English
publishDate 2025-07-01
publisher Elsevier
record_format Article
series Blood Advances
spelling doaj-art-e9e71539d7b242a58b4b45e5be57cc352025-08-20T03:12:56ZengElsevierBlood Advances2473-95292025-07-019143576358410.1182/bloodadvances.2025015818Venetoclax-based regimens in octogenarian patients with CLL: efficacy, safety, and comparison to BTKi in a multicenter cohortAndrea Serafin0Alessandro Cellini1Enrica Antonia Martino2Federica Mazzetto3Francesco Angotzi4Anna Maria Frustaci5Monia Marchetti6Riccardo Moia7Alessandro Sanna8Costantino Riemma9Francesca Cibien10Alessandro Noto11Enrico Lista12Myriam Foglietta13Candida Vitale14Vanessa Innao15Martina Bullo16Ester Lovato17Isacco Ferrarini18Costanza Andriola19Laura Ballotta20Idanna Innocenti21Alberto Fresa22Gianmarco Favrin23Marzia Varettoni24Elisa Santambrogio25Lorella Orsucci26Raffaella Pasquale27Massimo Moratti28Luca Laurenti29Marta Coscia30Paolo Sportoletti31Roberto Marasca32Francesca Romana Mauro33Caterina Patti34Enrico Derenzini35Lydia Scarfò36Paolo Ghia37Antonio Cuneo38Alessandra Tedeschi39Livio Trentin40Massimo Gentile41Andrea Visentin42Hematology Unit, Department of Medicine, University of Padova, Padua, ItalyHematology Unit, Department of Medicine, University of Padova, Padua, ItalyHematology Unit, Azienda Ospedaliera Annunziata, Cosenza, ItalyHematology Unit, Department of Medicine, University of Padova, Padua, ItalyHematology Unit, Department of Medicine, University of Padova, Padua, ItalyDepartment of Hematology, Azienda socio sanitaria territoriale Grande Ospedale Metropolitano Niguarda, Milan, ItalyHematology and Transplant Unit, Azienda ospedaliero universitaria Santi Antonio e Biagio, Alessandria, ItalyDivision of Hematology, Department of Translational Medicine, Università del Piemonte Orientale, Novara, ItalyHematology Unit, Department of Oncology, Azienda ospedaliero universitaria Careggi, Florence, ItalyIRCCS Istituto Romagnolo per lo Studio dei Tumori “Dino Amadori” - IRST, Meldola, ItalyHematology Unit, Ca’Foncello Hospital, Treviso, ItalyHematology Unit, Fondazione Istituto di ricovero e cura a carattere scientifico Ca' Granda Ospedale Maggiore Policlinico, Milan, ItalyHematology Unit, Santa Chiara Hospital, Azienda provinciale per i servizi sanitari, Trento, ItalyHematology Unit, Santa Croce e Carle General Hospital, Cuneo, ItalyDepartment of Molecular Biotechnology and Health Sciences, University of Torino and Division of Hematology, Azienda ospedaliero universitaria, Città della Salute e della Scienza di Torino, Turin, ItalyUnità Operativa Complessa di Ematologia, Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione Garibaldi, Catania, ItalyHematology Unit, Azienda Ospedaliera Ordine Mauriziano di Torino, Turin, ItalyDepartment of Engineering for Innovation Medicine, Section of Hematology, University of Verona, Verona, ItalyDepartment of Engineering for Innovation Medicine, Section of Hematology, University of Verona, Verona, ItalyHematology, Department of Translational and Precision Medicine, “Sapienza” University, Roma, ItalyHematology Unit, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, ItalyDipartimento di Diagnosi per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario Agostino Gemelli Istituto di ricovero e cura a carattere scientifico, Roma, ItalyDipartimento di Diagnosi per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario Agostino Gemelli Istituto di ricovero e cura a carattere scientifico, Roma, ItalyDivision of Hematology, Fondazione Istituto di ricovero e cura a carattere scientifico Policlinico San Matteo, Pavia, ItalyDivision of Hematology, Fondazione Istituto di ricovero e cura a carattere scientifico Policlinico San Matteo, Pavia, ItalyHematology Unit, Azienda ospedaliero universitaria Città della Salute e della Scienza di Torino, Turin, ItalyHematology Unit, Azienda ospedaliero universitaria Città della Salute e della Scienza di Torino, Turin, ItalyHematology Unit, Azienda Sanitaria Universitaria Friuli Centrale, Udine, ItalyHematology Unit, Azienda Sanitaria Universitaria Friuli Centrale, Udine, ItalyDipartimento di Diagnosi per Immagini, Radioterapia Oncologica ed Ematologia, Fondazione Policlinico Universitario Agostino Gemelli Istituto di ricovero e cura a carattere scientifico, Roma, ItalyDepartment of Molecular Biotechnology and Health Sciences, University of Torino and Division of Hematology, Azienda ospedaliero universitaria, Città della Salute e della Scienza di Torino, Turin, ItalyInstitute of Hematology, Center for Hemato-Oncological Research, University of Perugia, Perugia, ItalyHematology Unit, Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, ItalyHematology, Department of Translational and Precision Medicine, “Sapienza” University, Roma, ItalyOncohematology Unit, Azienda Ospedali Riuniti Villa Sofia-Cervello, Palermo, ItalyDivision of Onco-Hematology, Istituto europeo di oncologia, European Institute of Oncology Istituto di ricovero e cura a carattere scientifico, Milano, ItalyStrategic Research Program on Chronic Lymphocytic Leukemia, Istituto di ricovero e cura a carattere scientifico Ospedale San Raffaele, Milano, Italy; Medical School, Università Vita-Salute San Raffaele, Milano, ItalyStrategic Research Program on Chronic Lymphocytic Leukemia, Istituto di ricovero e cura a carattere scientifico Ospedale San Raffaele, Milano, Italy; Medical School, Università Vita-Salute San Raffaele, Milano, ItalyHematology Section, Department of Medical Sciences, Azienda Ospedaliera-Universitaria, Arcispedale S. Anna, University of Ferrara, Ferrara, ItalyDepartment of Hematology, Azienda socio sanitaria territoriale Grande Ospedale Metropolitano Niguarda, Milan, ItalyHematology Unit, Department of Medicine, University of Padova, Padua, Italy; Correspondence: Livio Trentin, Hematology Unit, Department of Medicine, University of Padova, via Nicolò Giustiniani 2, 35128 Padova, Italy;Hematology Unit, Azienda Ospedaliera Annunziata, Cosenza, Italy; Department of Pharmacy, Health and Nutritional Science, University of Calabria, Rende, Italy; Massimo Gentile, Hematology Unit, Department of Onco-Hematology, Azienda Ospedaliera Annunziata, Cosenza, and Department of Pharmacy, Health and Nutritional Science, University of Calabria, 87100 Rende, Italy;Hematology Unit, Department of Medicine, University of Padova, Padua, ItalyAbstract: Octogenarians represent a significant fraction of patients with chronic lymphocytic leukemia (CLL) but, despite the prevalence of the disease in this age group, limited data are available on the safety and efficacy of novel drugs in this subgroup. We conducted a multicenter retrospective study enrolling 120 octogenarian patients who received venetoclax (Ven) regimens in any line. Regarding efficacy, we found Ven to perform similarly to what is reported in younger patients with CLL, with an overall response rate of 91%, a complete response rate of 44%, and median progression-free survival of 44 months. Concerning safety, we report a toxicity profile that is consistent with previous reports, with most high-grade adverse events being of hematologic or infectious nature, given that 37% and 22% of patients experienced neutropenia or infections of grade 3 or higher. As part of our study, we compared the safety and efficacy data we collected with those obtained in a comparable Bruton tyrosine kinase inhibitor (BTKi)-treated population. We found that these 2 treatments were comparable in terms of overall efficacy, barring a higher rate of complete responses with Ven; safety profiles were different among the 2 groups given that BTKi-treated patients had more cardiovascular toxicities (26% vs 4%) and Ven-treated subjects experienced more infectious events (82% vs 49%). Our data point out that Ven-based regimens are safe and effective in octogenarian patients with CLL despite their higher clinical complexity and comorbidity burden and should provide some basis for the design of prospective studies to further evaluate the optimal treatment regimen in this patient population.http://www.sciencedirect.com/science/article/pii/S2473952925002277
spellingShingle Andrea Serafin
Alessandro Cellini
Enrica Antonia Martino
Federica Mazzetto
Francesco Angotzi
Anna Maria Frustaci
Monia Marchetti
Riccardo Moia
Alessandro Sanna
Costantino Riemma
Francesca Cibien
Alessandro Noto
Enrico Lista
Myriam Foglietta
Candida Vitale
Vanessa Innao
Martina Bullo
Ester Lovato
Isacco Ferrarini
Costanza Andriola
Laura Ballotta
Idanna Innocenti
Alberto Fresa
Gianmarco Favrin
Marzia Varettoni
Elisa Santambrogio
Lorella Orsucci
Raffaella Pasquale
Massimo Moratti
Luca Laurenti
Marta Coscia
Paolo Sportoletti
Roberto Marasca
Francesca Romana Mauro
Caterina Patti
Enrico Derenzini
Lydia Scarfò
Paolo Ghia
Antonio Cuneo
Alessandra Tedeschi
Livio Trentin
Massimo Gentile
Andrea Visentin
Venetoclax-based regimens in octogenarian patients with CLL: efficacy, safety, and comparison to BTKi in a multicenter cohort
Blood Advances
title Venetoclax-based regimens in octogenarian patients with CLL: efficacy, safety, and comparison to BTKi in a multicenter cohort
title_full Venetoclax-based regimens in octogenarian patients with CLL: efficacy, safety, and comparison to BTKi in a multicenter cohort
title_fullStr Venetoclax-based regimens in octogenarian patients with CLL: efficacy, safety, and comparison to BTKi in a multicenter cohort
title_full_unstemmed Venetoclax-based regimens in octogenarian patients with CLL: efficacy, safety, and comparison to BTKi in a multicenter cohort
title_short Venetoclax-based regimens in octogenarian patients with CLL: efficacy, safety, and comparison to BTKi in a multicenter cohort
title_sort venetoclax based regimens in octogenarian patients with cll efficacy safety and comparison to btki in a multicenter cohort
url http://www.sciencedirect.com/science/article/pii/S2473952925002277
work_keys_str_mv AT andreaserafin venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT alessandrocellini venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT enricaantoniamartino venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT federicamazzetto venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT francescoangotzi venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT annamariafrustaci venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT moniamarchetti venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT riccardomoia venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT alessandrosanna venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT costantinoriemma venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT francescacibien venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT alessandronoto venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT enricolista venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT myriamfoglietta venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT candidavitale venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT vanessainnao venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT martinabullo venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT esterlovato venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT isaccoferrarini venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT costanzaandriola venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT lauraballotta venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT idannainnocenti venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT albertofresa venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT gianmarcofavrin venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT marziavarettoni venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT elisasantambrogio venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT lorellaorsucci venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT raffaellapasquale venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT massimomoratti venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT lucalaurenti venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT martacoscia venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT paolosportoletti venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT robertomarasca venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT francescaromanamauro venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT caterinapatti venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT enricoderenzini venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT lydiascarfo venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT paologhia venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT antoniocuneo venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT alessandratedeschi venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT liviotrentin venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT massimogentile venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort
AT andreavisentin venetoclaxbasedregimensinoctogenarianpatientswithcllefficacysafetyandcomparisontobtkiinamulticentercohort