| アブストラクト | BACKGROUND: BRAF and MEK inhibitor combination therapy have significantly improved the outcome of several BRAF-mutation tumors, but it also confers the risk of drug-induced ocular adverse events (oAEs). However, very few studies focused on this risk. METHODS: The United States Food and Drug Administration Adverse Event Reporting System (FAERS) data from Quarter 1-2011 to Quarter 2-2022 were searched to detect signs of oAEs of three marketed BRAF and MEK inhibitor combination therapies: vemurafenib plus cobimetinib (V + C), dabrafenib plus trametinib (D + T), and encorafenib plus binimetinib (E + B). Disproportionality analyses were performed by calculating the proportional reporting ratio (PRR), chi2 (chi-square), and reporting odds ratios (RORs) with a 95% confidence interval (CI). RESULTS: A series of oAEs were identified, including 42 preferred terms, which could be classified into 8 aspects. In addition to previously reported oAEs, several unexpected oAE signals were detected. Moreover, differences in oAE profiles were found among three combination therapies (V + C, D + T, and E + B). CONCLUSIONS: Our findings support an association between several oAEs and BRAF and MEK inhibitor combination therapies, including several new oAEs. In addition, oAEs profiles may vary across the treatment regimens. Further studies are needed to better quantify these oAEs. |
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| ジャーナル名 | Expert opinion on drug safety |
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| 投稿日 | 2023/3/11 |
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| 投稿者 | Huang, Shuohan; Guo, Zihan; Wang, Mengmeng; She, Youjun; Ye, Xuan; Zhai, Qing; Liu, Jiyong; Du, Qiong |
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| 組織名 | Department of Pharmacy, Fudan University Shanghai Cancer Center, Shanghai, China.;Department of Oncology, Shanghai Medical College, Fudan University, Shanghai,;China. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/36896641/ |
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