Rethinking the feasibility and safety of venetoclax-obinutuzumab in chronic lymphocytic leukemia: non-traditional factors may play a role in clinical practice

Rethinking the feasibility and safety of venetoclax-obinutuzumab in chronic lymphocytic leukemia: non-traditional factors may play a role in clinical practice

The concept of fitness for novel agents in chronic lymphocytic leukemia (CLL) remains debated. Comorbidities and treatment-related logistics are increasingly recognized as key factors in treatment feasibility. Venetoclax-obinutuzumab (VO) has demonstrated efficacy in both fit and unfit patients in...

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Main Authors: Anna Maria Frustaci, Andrea Galitzia, Mariano Lucignano, Lorena Appio, Jacopo Olivieri, Alessandro Sanna, Claudia Baraté, Fabrizio Pane, Luana Schiattone, Beatrice Casadei, Isacco Ferrarini, Amalia Figuera, Paolo Sportoletti, Giacomo Loseto, Caterina Stelitano, Andrea Visentin, Melania Celli, Francesca Romana Mauro, Massimiliano Palombi, Marta Coscia, Vanessa Innao, Riccardo Moia, Marina Motta, Filomena Russo, Monica Tani, Annalisa Arcari, Elia Boccellato, Chiara Borella, Enrico Capochiani, Angela Ferrari, Massimo Gentile, Roberta Giachetti, Annamaria Giordano, Martina Bullo, Enrico Lista, Luigi Malandruccolo, Maurizio Musso, Marzia Varettoni, Federico Vozella, Francesca Cibien, Michele Merli, Laura Nocilli, Maria Cristina Pasquini, Azzurra Anna Romeo, Valentina Rossi, Gloria Turri, Anna Vanazzi, Marina Cavaliere, Alessandro Gozzetti, Lara Crucitti, Moira Lucesole, Marina Deodato, Annamaria Tomasso, Arianna Zappaterra, Roberta Murru, Caterina Patti, Luca Laurenti, Alessandra Tedeschi
Format: Article
Language:English
Published: Ferrata Storti Foundation 2025-06-01
Series:Haematologica
Online Access:https://haematologica.org/article/view/12141
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Summary:The concept of fitness for novel agents in chronic lymphocytic leukemia (CLL) remains debated. Comorbidities and treatment-related logistics are increasingly recognized as key factors in treatment feasibility. Venetoclax-obinutuzumab (VO) has demonstrated efficacy in both fit and unfit patients in clinical trials, yet real-world data remain limited. This retrospective, multicenter study analyzed disease- and patient-related factors affecting VO management and outcomes in 271 patients. Fitness was assessed using comorbidity indices (CLL-CI, CIRS, CCI), ECOG-PS, and caregiver need. Adverse events (AEs) and treatment modifications were evaluated across four treatment phases. Median age was 66 years (19% ≥75); 83% had comorbidities, 34% required polypharmacy, and 10% needed caregiver support. Overall, 96% completed debulking, 89% the full regimen, while 11% discontinued due to toxicity (Tox-DTD). Grade ≥3 AEs occurred in 55%, tumor lysis syndrome in 6%, severe infusion-related reactions in 5%. Overall, 3.3% died during treatment. Unfit patients did not show a significantly higher risk of treatment modifications due to AEs. Dose adjustments were more frequent during debulking. None of the validated fitness scores predicted treatment feasibility or Tox-DTD. Global feasibility was impacted by age (p .002), prior malignancies (p .003), prolonged steroid pre-treatment (p
ISSN:0390-6078
1592-8721

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