Wu Xinhua, Liao Jing, Chen Wei, Dou Jianwei
Department of Natural Medicinal Chemistry, School of Pharmacy, Xi'an Jiaotong University, Xi'an.
Department of Pharmacy, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
Nucl Med Commun. 2025 Oct 1;46(10):905-912. doi: 10.1097/MNM.0000000000002015. Epub 2025 Jun 30.
177 Lu-DOTA-TATE (LUTATHERA) is a crucial radiopharmaceutical in neuroendocrine tumor therapy, yet real-world long-term safety data across diverse populations remain limited. This study aims to comprehensively assess the postmarketing safety of LUTATHERA using a real-world pharmacovigilance database.
We conducted an observational study using the US Food and Drug Administration's Adverse Event Reporting System (FAERS) database from the first quarter of 2018 to the third quarter of 2024. Reports were filtered for LUTATHERA as the primary suspect. The characteristics and onset time of LUTATHERA-associated adverse events were analyzed. The disproportionality analysis via reporting odds ratio (ROR) and Bayesian confidence propagation neural network was employed to identify significant adverse event signals associated with LUTATHERA.
A total of 4058 reports identified with LUTATHERA as the primary suspected drug. LUTATHERA was linked to increased risks in in general disorders, gastrointestinal, hematological, metabolic, hepatobiliary, and endocrine systems. Common adverse events like nausea, thrombocytopenia, and anemia aligned with clinical trial data. Novel and serious signals such as intestinal obstruction [ROR = 5.62, information component (IC) = 2.49], gastrointestinal hemorrhage (ROR = 2.84, IC = 1.50), carcinoid heart disease (ROR = 571.03, IC = 8.93), and esophageal varices hemorrhage (ROR = 11.92, IC = 3.57) were also identified. LUTATHERA-associated adverse events typically occurred within 2 months, with a median onset of 54 days.
This study enhances understanding of LUTATHERA's safety profile, offers clinicians valuable data, and advocates continuous pharmacovigilance. Continuous pharmacovigilance and potential label updates are recommended.
177镥-多柔比星-奥曲肽（LUTATHERA）是神经内分泌肿瘤治疗中的一种关键放射性药物，但不同人群的真实世界长期安全性数据仍然有限。本研究旨在使用真实世界药物警戒数据库全面评估LUTATHERA的上市后安全性。
我们使用美国食品药品监督管理局不良事件报告系统（FAERS）数据库进行了一项观察性研究，时间跨度为2018年第一季度至2024年第三季度。报告以LUTATHERA作为主要可疑药物进行筛选。分析了与LUTATHERA相关不良事件的特征和发病时间。采用报告比值比（ROR）和贝叶斯置信传播神经网络进行不成比例分析，以识别与LUTATHERA相关的显著不良事件信号。
共识别出4058份以LUTATHERA为主要可疑药物的报告。LUTATHERA与一般疾病、胃肠道、血液学、代谢、肝胆和内分泌系统风险增加有关。恶心、血小板减少和贫血等常见不良事件与临床试验数据一致。还识别出了肠梗阻[ROR = 5.62，信息成分（IC） = 2.49]、胃肠道出血（ROR = 2.84，IC = 1.50）、类癌心脏病（ROR = 571.03，IC = 8.93）和食管静脉曲张出血（ROR = 11.92，IC = 3.57）等新的严重信号。与LUTATHERA相关的不良事件通常在2个月内发生，中位发病时间为54天。
本研究增进了对LUTATHERA安全性的理解，为临床医生提供了有价值的数据，并倡导持续的药物警戒。建议持续进行药物警戒并可能更新标签。
