Che Xinzhen, Zhu Yong
First Clinical Medical College, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, China.
2 Shandong University of Traditional Chinese Medicine Affiliated Hospital, Jinan, Shandong, China.
Front Pharmacol. 2025 Jun 26;16:1561937. doi: 10.3389/fphar.2025.1561937. eCollection 2025.
This study aims to analyze potential adverse events (AEs) associated with ripretinib and sunitinb in gastrointestinal stromal tumor (GIST) treatment using data from the FDA Adverse Event Reporting System (FAERS). The findings provide insights for future research to improve the safety and clinical management of ripretinib and sunitinib.
Adverse Drug Event (ADE) reports related to ripretinib and sunitinib were extracted from the FAERS database, covering the period from Q2 2020 to Q4 2024 and Q1 2006 to Q4 2024, respectively. ADEs were classified and described according to Preferred Terms (PTs) and System Organ Classes (SOCs) in the Medical Dictionary for Regulatory Activities (MedDRA). Disproportionality analysis, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS), was employed to identify significant signals.
A total of 3,636 and 34,768 ADE reports related to ripretinib and sunitinib were identified using four disproportionality analysis methods. The top five ADR signals for ripretinib include hepatic embolization, tumor compression, hyperkeratosis, tumor excision and tumor pain. For sunitinib, the five strongest ADR signals are metastatic renal cell carcinoma, diffuse uveal melanocytic proliferation, renal cancer metastasis, connective tissue neoplasm and salivary gland fistula. Both drugs share significant ADRs including palmar-plantar erythrodysesthesia syndrome, disease progression and hyperkeratosis. Furthermore, subgroup analysis was conducted to explore sex difference in ripretinib and sunitinib.
This study validated known AEs and identified new potential safety signals associated with ripretinib and sunitinib in GIST treatment. These findings contribute to the understanding of ripretinib and sunitinib, providing valuable evidence for improving its clinical use.
本研究旨在利用美国食品药品监督管理局不良事件报告系统（FAERS）的数据，分析瑞派替尼和舒尼替尼在胃肠道间质瘤（GIST）治疗中潜在的不良事件（AE）。研究结果为未来改善瑞派替尼和舒尼替尼安全性及临床管理的研究提供了见解。
分别从FAERS数据库中提取2020年第二季度至2024年第四季度以及2006年第一季度至2024年第四季度期间与瑞派替尼和舒尼替尼相关的药品不良事件（ADE）报告。根据《药物监管活动医学词典》（MedDRA）中的首选术语（PT）和系统器官分类（SOC）对ADE进行分类和描述。采用不成比例分析，包括报告比值比（ROR）、比例报告比值（PRR）、贝叶斯置信传播神经网络（BCPNN）和多项目伽马泊松收缩器（MGPS），来识别显著信号。
使用四种不成比例分析方法共识别出3636份与瑞派替尼相关的ADE报告和34768份与舒尼替尼相关的ADE报告。瑞派替尼的前五大不良反应信号包括肝栓塞、肿瘤压迫、角化过度、肿瘤切除和肿瘤疼痛。对于舒尼替尼，五个最强的不良反应信号是转移性肾细胞癌、弥漫性葡萄膜黑素细胞增生、肾癌转移、结缔组织肿瘤和唾液腺瘘。两种药物都有显著的不良反应，包括手足红斑感觉异常综合征、疾病进展和角化过度。此外，还进行了亚组分析以探讨瑞派替尼和舒尼替尼的性别差异。
本研究验证了已知的AE，并识别出与瑞派替尼和舒尼替尼在GIST治疗中相关的新潜在安全信号。这些发现有助于对瑞派替尼和舒尼替尼的理解，为改善其临床应用提供了有价值的证据。
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