| アブストラクト | This study aims to investigate the adverse effects of immune checkpoint inhibitors (ICIs) on the female and male reproductive systems. In the FDA Adverse Event Reporting System (FAERS) database, adverse reactions under the "Reproductive system and breast disorders" category in the System Organ Classes were included, covering a period from January 1, 2015, to June 30, 2023. We identified 133,512 patients treated with ICIs. Immune checkpoint inhibitor-related reproductive adverse effects (irRAEs) were reported in 568 (0.43%) patients. Spermatogenesis abnormality (ROR025 = 7.91) had the highest signal strength associated with ICI use in males. Genital tract fistula was the only significant irRAE (ROR025 = 2.72) in females. PD-1 inhibitors pose greater risk than CTLA-4 inhibitors (OR = 1.65 [1.05-2.79], p = 0.045). Gynecologic cancers in females (OR = 3.77 [2.82-4.99], p < 0.0001) and urogenital cancers in males (OR = 1.56 [1.17-2.06], p = 0.0018) carried the highest risk compared to other cancers. Additional targeted drugs (OR = 2.32 [1.76-3.02], p < 0.0001), particularly lenvatinib (OR = 3.50 [2.48-4.94], p < 0.0001) and cabozantinib (OR = 3.71 [1.96-7.03], p < 0.0001) significantly increased the risk for females. Additional use of chemotherapy drugs was associated with a significant reduction in the risk for males (OR = 0.65 [0.42-0.96], p = 0.042) except for doxorubicin (OR = 2.58 [1.22-5.47], p = 0.013) and cyclophosphamide (OR = 2.36 [1.05-5.29], p = 0.038). This study demonstrates that ICIs could potentially lead to a wide range of adverse effects in the reproductive system in both males and females. |
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| ジャーナル名 | Scientific reports |
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| Pubmed追加日 | 2025/3/6 |
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| 投稿者 | Koylu, Bahadir; Esen, Bugra Han; Bektas, Sevval Nur; Ozbek, Lasin; Turan, Volkan; Urman, Bulent; Oktem, Ozgur; Selcukbiricik, Fatih |
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| 組織名 | Department of Internal Medicine, Division of Medical Oncology, Koc University;School of Medicine, Istanbul, Turkey. bkoylu@ku.edu.tr.;Hospital, 34010, Topkapi, Istanbul, Turkey. bkoylu@ku.edu.tr.;Koc University School of Medicine, Istanbul, Turkey.;Istanbul Health and Technology University Faculty of Medicine, Department of;Obstetrics and Gynecology, Istanbul, Turkey.;Department of Obstetrics and Gynecology, Koc University School of Medicine,;Istanbul, Turkey.;Istanbul, Turkey. ooktem@ku.edu.tr.;Department of Obstetrics and Gynecology, Koc University Hospital, 34010, Topkapi,;School of Medicine, Istanbul, Turkey. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/40044844/ |
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