Fonseca Rodrigo, Liu Alex J, Langlais Blake T, Almader-Douglas Diana, Vikram Holenarasipur R, Hilal Talal
Division of Internal Medicine, Mayo Clinic, Phoenix, AZ.
Division of Hematology and Medical Oncology, Mayo Clinic, Phoenix, AZ.
Blood Neoplasia. 2024 Dec 4;2(1):100061. doi: 10.1016/j.bneo.2024.100061. eCollection 2025 Feb.
Bispecific antibodies (BsAbs) have emerged as a novel immunotherapy option for the treatment of non-Hodgkin lymphoma; however; their safety profiles remain underexplored. We conducted a systematic review and meta-analysis to better delineate the safety profiles of BsAbs, focusing on the prevalence and rates of infection, neutropenia, cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS). A comprehensive literature search led to the inclusion of 32 trials, with a total of 2192 patients. Median age of participants was 66 years (range, 55-84) with a median of 2 prior lines of therapy (range, 0-5). At a median follow-up of 9.4 months (range, 2.8-32 , the pooled prevalence of all-grade and grade ≥3 neutropenia was 38% and 26%, respectively, with all-grade and grade ≥3 infections occurring at a rate of 38% and 12%, respectively. The prevalence of all grade CRS was 48% but only 2% was grade ≥3, whereas ICANS was infrequent (5% all grade). Stratification revealed both increased all-grade neutropenia and infection rates with combination therapy in comparison to BsAbs monotherapy. Despite these variations, BsAbs demonstrated an overall manageable safety profile, suggesting their viability as a treatment option in the relapsed/refractory setting. Standardized safety reporting and vigilant monitoring are essential to optimize their clinical use and improve patient outcomes.
双特异性抗体（BsAbs）已成为治疗非霍奇金淋巴瘤的一种新型免疫疗法；然而，其安全性仍未得到充分探索。我们进行了一项系统评价和荟萃分析，以更好地描述BsAbs的安全性，重点关注感染、中性粒细胞减少、细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS）的发生率和比率。全面的文献检索纳入了32项试验，共2192例患者。参与者的中位年龄为66岁（范围55 - 84岁），既往治疗的中位线数为2线（范围0 - 5线）。中位随访9.4个月（范围2.8 - 32个月），所有级别和≥3级中性粒细胞减少的合并发生率分别为38%和26%，所有级别和≥3级感染的发生率分别为38%和12%。所有级别CRS的发生率为48%，但≥3级仅为2%，而ICANS不常见（所有级别为5%）。分层分析显示，与BsAbs单药治疗相比，联合治疗的所有级别中性粒细胞减少和感染率均升高。尽管存在这些差异，BsAbs总体安全性可控，表明其在复发/难治性患者中作为一种治疗选择的可行性。标准化的安全性报告和密切监测对于优化其临床应用和改善患者预后至关重要。
