Serafin Andrea, Cellini Alessandro, Martino Enrica Antonia, Mazzetto Federica, Angotzi Francesco, Frustaci Anna Maria, Marchetti Monia, Moia Riccardo, Sanna Alessandro, Riemma Costantino, Cibien Francesca, Noto Alessandro, Lista Enrico, Foglietta Myriam, Vitale Candida, Innao Vanessa, Bullo Martina, Lovato Ester, Ferrarini Isacco, Andriola Costanza, Ballotta Laura, Innocenti Idanna, Fresa Alberto, Favrin Gianmarco, Varettoni Marzia, Santambrogio Elisa, Orsucci Lorella, Pasquale Raffaella, Moratti Massimo, Laurenti Luca, Coscia Marta, Sportoletti Paolo, Marasca Roberto, Mauro Francesca Romana, Patti Caterina, Derenzini Enrico, Scarfò Lydia, Ghia Paolo, Cuneo Antonio, Tedeschi Alessandra, Trentin Livio, Gentile Massimo, Visentin Andrea
Hematology Unit, Department of Medicine, University of Padova, Padua, Italy.
Hematology Unit, Azienda Ospedaliera Annunziata, Cosenza, Italy.
Blood Adv. 2025 Jul 22;9(14):3576-3584. doi: 10.1182/bloodadvances.2025015818.
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.
八旬老人占慢性淋巴细胞白血病（CLL）患者的很大一部分，尽管该疾病在这个年龄组中很普遍，但关于新药在该亚组中的安全性和有效性的数据有限。我们进行了一项多中心回顾性研究，纳入了120例接受过任何线维奈克拉（Ven）方案治疗的八旬老人患者。在疗效方面，我们发现Ven的表现与年轻CLL患者的报道相似，总缓解率为91%，完全缓解率为44%，无进展生存期中位数为44个月。在安全性方面，我们报告的毒性特征与先前的报道一致，大多数高级别不良事件为血液学或感染性，因为37%和22%的患者发生了3级或更高等级的中性粒细胞减少或感染。作为我们研究的一部分，我们将收集到的安全性和有效性数据与在可比的布鲁顿酪氨酸激酶抑制剂（BTKi）治疗人群中获得的数据进行了比较。我们发现这两种治疗在总体疗效方面具有可比性，不过Ven的完全缓解率更高；两组的安全性特征不同，因为接受BTKi治疗的患者有更多的心血管毒性（26%对4%），而接受Ven治疗的受试者经历了更多的感染事件（82%对49%）。我们的数据指出，基于Ven的方案在患有CLL的八旬老人患者中是安全有效的，尽管他们的临床复杂性和合并症负担较高，并且应该为设计前瞻性研究提供一些依据，以进一步评估该患者群体的最佳治疗方案。
