Pharmacovigilance analysis of immune checkpoint inhibitor-related reproductive adverse effects based on the FDA adverse event reporting system

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dc.authorid0000-0002-4462-6393
dc.authorid0000-0001-7430-1381
dc.authorid0000-0002-6953-3804
dc.authorid0000-0002-2828-555X
dc.authorid0000-0003-2287-799X
dc.authorid0000-0002-9021-2220
dc.authorid0000-0003-1966-3886
dc.contributor.authorKöylü, Bahadır
dc.contributor.authorEsen, Buğra Han
dc.contributor.authorBektaş, Şevval Nur
dc.contributor.authorÖzbek, Laşin
dc.contributor.authorTuran, Volkan
dc.contributor.authorUrman, Bülent
dc.contributor.authorÖktem, Özgür
dc.contributor.authorSelçukbiricik, Fatih
dc.date.accessioned2025-03-14T11:55:51Z
dc.date.available2025-03-14T11:55:51Z
dc.date.issued2025
dc.departmentFakülteler, Tıp Fakültesi, Cerrahi Tıp Bilimleri Bölümü, Kadın Hastalıkları ve Doğum Ana Bilim Dalı
dc.description.abstractThis 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.
dc.identifier.citationKöylü, B., Esen, B. H., Bektaş, Ş. N., Özbek, L., Turan, V., Urman, B., Öktem, Ö., & Selçukbiricik, F. (2025). Pharmacovigilance analysis of immune checkpoint inhibitor-related reproductive adverse effects based on the FDA adverse event reporting system. Scientific Reports, 15(1), pp. 1-13. https://doi.org/10.1038/s41598-025-91476-0
dc.identifier.doi10.1038/s41598-025-91476-0
dc.identifier.endpage13
dc.identifier.issn2045-2322
dc.identifier.issue1
dc.identifier.pmid40044844
dc.identifier.scopus2-s2.0-86000096941
dc.identifier.scopusqualityQ1
dc.identifier.startpage1
dc.identifier.urihttps://doi.org/10.1038/s41598-025-91476-0
dc.identifier.urihttps://hdl.handle.net/20.500.13055/937
dc.identifier.volume15
dc.identifier.wosWOS:001440274800028
dc.identifier.wosqualityQ1
dc.indekslendigikaynakPubMed
dc.indekslendigikaynak.otherSCI-E - Science Citation Index Expanded
dc.institutionauthorTuran , Volkan
dc.institutionauthorid0000-0003-2287-799X
dc.language.isoen
dc.publisherSpringer Nature
dc.relation.ispartofScientific Reports
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsinfo:eu-repo/semantics/openAccess
dc.subjectFemale Genital System
dc.subjectImmune Checkpoint Inhibitor
dc.subjectMale Genital System
dc.subjectNeoplasm
dc.titlePharmacovigilance analysis of immune checkpoint inhibitor-related reproductive adverse effects based on the FDA adverse event reporting system
dc.typeArticle
dspace.entity.typePublication

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