| アブストラクト | OBJECTIVES: KRAS (G12C) inhibitors (sotorasib and adagrasib) have approved treatment in patients with KRAS (G12C)-mutated non-small cell lung cancer (NSCLC). The post-marketing data concerning KRAS (G12C) inhibitors remain limited, and the outcomes of relevant studies are yet to yield conclusive evidence supporting the long-term safety of KRAS (G12C) inhibitors. MATERIALS AND METHODS: This investigation comprehensively assessed adverse events (AEs) attributed to KRAS (G12C) inhibitors by employing advanced data mining techniques, utilizing the FDA Adverse Event Reporting System (FAERS). The dataset encompasses the period from the first quarter of 2021 to the first quarter of 2024. A disproportionality analysis was conducted to quantify the correlation between KRAS (G12C) inhibitors and AEs. The metrics employed for the evaluation of disproportionality comprise the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the information component (IC), and the empirical Bayesian geometric mean (EBGM). RESULTS: A total of 2,253 and 486 reports were identified as related to sotorasib and adagrasib, with the identification of 51 and 26 preferred terms, respectively. The most frequent AEs of sotorasib comprised diarrhoea (ROR 5.27), hepatotoxicity (ROR 38.09), alanine aminotransferase increased (ROR 17.41), aspartate aminotransferase increased (ROR 20.88), and hepatic function abnormal (ROR 19.88). The most common AEs of adagrasib included diarrhoea (ROR 4.21), nausea (ROR 3.84), vomiting (ROR 5.36), decreased appetite (ROR 4.79), and dehydration (ROR 7.00). A relatively reduced risk of hepatotoxicity but a increased risk of serious AEs in adagrasib compared to sotorasib (P < 0.001). CONCLUSION: Our findings would provide valued evidence for healthcare professionals to recognize AEs associated with KRAS (G12C) inhibitors and differences between sotorasib and adagrasib, and guide their clinical practice. |
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| ジャーナル名 | Lung cancer (Amsterdam, Netherlands) |
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| 投稿日 | 2024/9/30 |
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| 投稿者 | Chen, Maohua; Huang, Yaping; Jiang, Shaojun; Ke, Chengjie |
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| 組織名 | Department of Pharmacy, Pingtan Comprehensive Experimental Area Hospital, Pingtan;Comprehensive Experimental Area, Fuzhou 350400, China.;Department of Pharmacy, Shengli Clinical Medical College of Fujian Medical;University, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial;Hospital, NO.134 Dongjie Street, Fuzhou 350001, Fujian, China.;Department of Pharmacy, The First Affiliated Hospital of Fujian Medical;University, Fuzhou 350005, China; Department of Pharmacy, National Regional;Medical Center, Binhai Campus of the First Affiliated Hospital, Fujian Medical;University, Fuzhou 350005, China.;University, Fuzhou 350005, China. Electronic address: kcj1994@fjmu.edu.cn. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39342769/ |
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