| アブストラクト | BACKGROUND: No head-to-head clinical trials have compared the differences in adverse events (AEs) between nivolumab plus ipilimumab (NIVO-IPI) and nivolumab plus cabozantinib (NIVO-CABO) in the treatment of metastatic renal cell carcinoma (mRCC). AIM: We analysed the two largest real-world databases, the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) and the World Health Organization's VigiBase, to elucidate the differences in AEs between NIVO-IPI and NIVO-CABO. METHOD: In total, 40,376 and 38,022 records were extracted from FAERS and VigiBase, and 193 AEs were analysed. The reporting odds ratios (ROR) with 95% confidence interval were calculated using a disproportionality analysis (NIVO-CABO/NIVO-IPI). RESULTS: The reported numbers of immune-related AEs, including myocarditis, colitis, and hepatitis, were significantly higher with NIVO-IPI (ROR = 0.18 for FAERS and 0.13 for VigiBase). Contrarily, the reported numbers of other AEs, including gastrointestinal disorders (ROR = 2.68 and 2.92) and skin and subcutaneous tissue disorders (ROR = 2.94 and 3.55), considered to be potentiated by the combination of NIVO and CABO, were higher with NIVO-CABO. CONCLUSION: Our findings contribute to the selection and clinical management of NIVO-IPI and NIVO-CABO, which minimizes the risk of AEs for individual patients with mRCC by considering distinctive differences in the AE profiles. |
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| 投稿者 | Oka, Yurie; Matsumoto, Jun; Takeda, Tatsuaki; Iwata, Naohiro; Niimura, Takahiro; Ozaki, Aya Fukuma; Bekku, Kensuke; Hamano, Hirofumi; Araki, Motoo; Ishizawa, Keisuke; Zamami, Yoshito; Ariyoshi, Noritaka |
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| 組織名 | Department of Personalized Medicine and Preventive Healthcare Sciences, Faculty;of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, 2-5-1;Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.;Shikata-cho, Kita-ku, Okayama, 700-8558, Japan. matsumotoj@okayama-u.ac.jp.;Department of Education and Research Centre for Clinical Pharmacy, Faculty of;Pharmaceutical Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama,;700-8558, Japan. matsumotoj@okayama-u.ac.jp.;Department of Pharmacy, Okayama University Hospital, 2-5-1 Shikata-cho, Kita-ku,;Okayama, 700-8558, Japan. matsumotoj@okayama-u.ac.jp.;700-8558, Japan.;Okayama, 700-8558, Japan.;Department of Clinical Pharmacology and Therapeutics, Graduate School of;Biomedical Sciences, Tokushima University, 2-50-1 Kuramoto-cho, Tokushima,;700-8503, Japan.;Department of Clinical Pharmacy Practice, School of Pharmacy & Pharmaceutical;Sciences, University of California Irvine, 101 Theory Ste 100, Irvine, CA, 92697,;USA.;Department of Urology, Faculty of Medicine, Dentistry, and Pharmaceutical;Sciences, Okayama University, 2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558,;Japan. |
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