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Comparative Study
. 2025 Jul 22;9(14):3576-3584.
doi: 10.1182/bloodadvances.2025015818.

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

Andrea Serafin  1 , Alessandro Cellini  1 , Enrica Antonia Martino  2 , Federica Mazzetto  1 , Francesco Angotzi  1 , Anna Maria Frustaci  3 , Monia Marchetti  4 , Riccardo Moia  5 , Alessandro Sanna  6 , Costantino Riemma  7 , Francesca Cibien  8 , Alessandro Noto  9 , Enrico Lista  10 , Myriam Foglietta  11 , Candida Vitale  12 , Vanessa Innao  13 , Martina Bullo  14 , Ester Lovato  15 , Isacco Ferrarini  15 , Costanza Andriola  16 , Laura Ballotta  17 , Idanna Innocenti  18 , Alberto Fresa  18 , Gianmarco Favrin  19 , Marzia Varettoni  19 , Elisa Santambrogio  20 , Lorella Orsucci  20 , Raffaella Pasquale  21 , Massimo Moratti  21 , Luca Laurenti  18 , Marta Coscia  12 , Paolo Sportoletti  22 , Roberto Marasca  23 , Francesca Romana Mauro  16 , Caterina Patti  24 , Enrico Derenzini  25 , Lydia Scarfò  26   27 , Paolo Ghia  26   27 , Antonio Cuneo  28 , Alessandra Tedeschi  3 , Livio Trentin  1 , Massimo Gentile  2   29 , Andrea Visentin  1
Affiliations
Comparative Study

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

Andrea Serafin et al. Blood Adv. .

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.

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Conflict of interest statement

Conflict-of-interest disclosure: P.G. received honoraria from AbbVie, AstraZeneca, BeiGene, Bristol Myers Squibb, Johnson & Johnson, Galapagos, Lilly/Loxo Oncology, Merck Sharp & Dohme, and Roche; and research support from AbbVie, AstraZeneca, Bristol Myers Squibb, Johnson & Johnson, and Lilly/Loxo Oncology. I.F. received research support from AbbVie, BeiGene, and Eli Lilly. M.V. received research support from AbbVie, AstraZeneca, BeiGene, and Johnson & Johnson. A. Sanna received research support from AstraZeneca and Johnson & Johnson. R. Marasca received research support from AbbVie, Johnson & Johnson, BeiGene, and AstraZeneca. A. Cuneo received research support from AbbVie, AstraZeneca, BeiGene, Janssen, and Lilly. M. Marchetti received research support from Novartis, Sanofi, AstraZeneca, Roche, Gilead, and GlaxoSmithKline. A.M.F. received research support from Janssen, BeiGene, AbbVie, and AstraZeneca. P.S. received research support from AbbVie, Johnson & Johnson, BeiGene, and AstraZeneca. C.V. received research support from AbbVie, AstraZeneca, and Janssen. The remaining authors declare no competing financial interests.

Figures

None
Graphical abstract
Figure 1.
Figure 1.
Survival outcomes and significant predictors. PFS and OS of the Ven-treated patients (A-B). PFS and OS of the significative variables (C-D). mo, months.
See this image and copyright information in PMC

References

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