REVIEW article
Front. Pharmacol.
Sec. Predictive Toxicology
Volume 16 - 2025 | doi: 10.3389/fphar.2025.1561937
This article is part of the Research TopicToxicity Mechanisms, Exposure, Toxicokinetic and Risk Assessment Aspects of Metals, Toxic for Animals and Humans, Volume IIIView all 11 articles
Gastrointestinal stromal tumors with the use of ripretinib and sunitinib: realworld adverse event analysis based on the FDA adverse event reporting system (FAERS)
Provisionally accepted
- 1First College of Clinical Medicine, Shandong University of Traditional Chinese Medicine, Jinan, China
- 2Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, Shandong Province, China
Select one of your emails
You have multiple emails registered with Frontiers:
Notify me on publication
Please enter your email address:
If you already have an account, please login
You don't have a Frontiers account ? You can register here
Objective: 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.Methods: 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. Results: 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. Conclusion: 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.
Keywords: ripretinib, Sunitinib, adverse events, FAERS, GIST treatment
Received: 16 Jan 2025; Accepted: 16 Jun 2025.
Copyright: © 2025 Che and Zhu. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Yong Zhu, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, 250011, Shandong Province, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.