Jin Yan, Jin Yongli, Cui Yan, Zheng Rongzhen
Department of Hemodialysis Room, Yanbian University Hospital, Yanji, China.
Department of Anesthesiology, Yanbian University Hospital, Yanji, China.
J Immunother Cancer. 2025 May 7;13(5):e012384. doi: 10.1136/jitc-2025-012384.
We commend Liang for shining a spotlight on second primary malignancies after bispecific antibody (BsAb) therapy, yet several clinical nuances deserve consideration. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS)-derived case-fatality rates likely overstate risk, prior genotoxic treatments confound causality, and pooling heterogeneous BsAb constructs may blur construct-specific signals. The 124-day median latency hints at misclassification, while sparse African data limit global relevance. Risk-adapted surveillance-grounded in clonal haematopoiesis, prior cytotoxic exposure and BsAb construct-may be more pragmatic than blanket monitoring.
我们赞扬梁(音译)聚焦双特异性抗体(BsAb)治疗后的第二原发性恶性肿瘤,然而,有几个临床细微差别值得考虑。美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)得出的病死率可能高估了风险,既往的基因毒性治疗混淆了因果关系,并且将异质性BsAb构建体合并可能会模糊构建体特异性信号。124天的中位潜伏期暗示存在错误分类,而非洲地区的数据稀少限制了其全球相关性。基于克隆性造血、既往细胞毒性暴露和BsAb构建体进行风险适应性监测可能比全面监测更为务实。