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. 2025 Jun 26:16:1561937.
doi: 10.3389/fphar.2025.1561937. eCollection 2025.

Gastrointestinal stromal tumors with the use of ripretinib and sunitinib: real-world adverse event analysis based on the FDA adverse event reporting system (FAERS)

Xinzhen Che  1 , Yong Zhu  2
Affiliations

Gastrointestinal stromal tumors with the use of ripretinib and sunitinib: real-world adverse event analysis based on the FDA adverse event reporting system (FAERS)

Xinzhen Che et al. Front Pharmacol. .

Erratum in

Abstract

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: FAERS; GIST treatment; adverse events; ripretinib; sunitinib.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

FIGURE 1
FIGURE 1
Flowchart of ripretinib and sunitinib in FAERS.
FIGURE 2
FIGURE 2
Comparation of reporting year between snuitinib and ripretinib.
FIGURE 3
FIGURE 3
Comparation between ripretinib and sunitinib at the SOC level. (A) AE signals at the SOC level in ripretinib. (B) AE signals at the SOC level in sunitinib.
FIGURE 4
FIGURE 4
Subgroup analysis at the PT level of ripretinib.
FIGURE 5
FIGURE 5
Subgroup analysis at the PT level of sunitinib.
See this image and copyright information in PMC

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