Chen Heng, Ma Junlong
Department of Pharmacy, The First Hospital of Changsha (The Affiliated Changsha Hospital of Xiangya School of Medicine, Central South University).
Center of Clinical Pharmacology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.
Clin Nucl Med. 2025 Aug 1;50(8):714-720. doi: 10.1097/RLU.0000000000005861. Epub 2025 Apr 30.
Lutathera, a key therapy for gastroenteropancreatic neuroendocrine tumors, has demonstrated efficacy, but its real-world safety profile remains unclear. This study aims to conduct a comprehensive analysis of the adverse events (AEs) associated with Lutathera using FDA Adverse Event Reporting System (FAERS) data.
A retrospective pharmacovigilance analysis was conducted using FAERS data from Q4 2019 to Q3 2024. AE reports involving Lutathera were identified, and a case/non-case approach was employed to evaluate AE signals using disproportionality analysis methods, including the reporting odds ratio and information component (IC). Patient demographics, time to AE onset, and system organ class (SOC) involvement were analyzed.
After data processing, a total of 4284 AE reports associated with Lutathera were analyzed. The median time to AE onset was 113.5 days. Lutathera-related AEs exhibited a notably high mortality rate, reaching as much as 31.2%. Statistically significant signals were detected across 13 SOCs and multiple preferred terms (PTs). Among the SOCs, the most pronounced signals were observed in the category of endocrine disorders. The leading PTs included nonspecific disorders (IC 025 : 5.92), carcinoid syndrome (IC 025 : 5.69), and carcinoid crisis (IC 025 : 5.62). Moreover, several PTs not documented in the drug's labeling were reported, such as encephalitis, intestinal ischemia, and disseminated intravascular coagulation.
Our study utilized real-world data to identify multiple risk signals associated with Lutathera, providing additional evidence to support its rational use. However, due to the inherent limitations of the FAERS database, further research is warranted to validate these findings.
Lutathera是胃肠胰神经内分泌肿瘤的一种关键治疗方法，已显示出疗效，但其实际的安全性概况仍不清楚。本研究旨在使用美国食品药品监督管理局不良事件报告系统（FAERS）的数据，对与Lutathera相关的不良事件（AE）进行全面分析。
使用2019年第四季度至2024年第三季度的FAERS数据进行回顾性药物警戒分析。识别涉及Lutathera的AE报告，并采用病例/非病例方法，使用不成比例分析方法（包括报告比值比和信息成分（IC））评估AE信号。分析了患者人口统计学、AE发生时间和系统器官分类（SOC）受累情况。
数据处理后，共分析了4284份与Lutathera相关的AE报告。AE发生的中位时间为113.5天。与Lutathera相关的AE显示出显著高的死亡率，高达31.2%。在13个SOC和多个首选术语（PT）中检测到具有统计学意义的信号。在SOC中，在内分泌疾病类别中观察到最明显的信号。主要的PT包括非特异性疾病（IC 025：5.92）、类癌综合征（IC 025：5.69）和类癌危象（IC 025：5.62）。此外，还报告了该药物标签中未记录的几个PT，如脑炎、肠缺血和弥散性血管内凝血。
我们的研究利用实际数据识别了与Lutathera相关的多个风险信号，为支持其合理使用提供了额外证据。然而，由于FAERS数据库的固有局限性，有必要进行进一步研究以验证这些发现。
