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已发表论文
免疫检查点抑制剂治疗妇科癌症患者免疫相关不良事件的临床特征及管理：一项回顾性研究
Authors Xia Y, Gao S, Wei Q, Gu W, Li X , Qu H
Received 14 September 2025
Accepted for publication 1 January 2026
Published 21 January 2026 Volume 2026:15 566542
DOI https://doi.org/10.2147/ITT.S566542
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Prof. Dr. Michael Shurin
Yu Xia,1,* Song Gao,1,* Qianxue Wei,1,* Wen Gu,2,* Xiuqin Li,1 Hui Qu1
1Department of Obstetrics and Gynecology, Shengjing Hospital of China Medical University, Shenyang, People’s Republic of China; 2Department of Oncology, Shengjing Hospital of China Medical University, Shenyang, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Xiuqin Li, Email lixq_cmu@163.com Hui Qu, Email quhui@sj-hospital.org
Purpose: This study aimed to characterize the clinical profile, risk factors, and management of immune-related adverse events (irAEs) in patients with gynecologic cancers treated with immune checkpoint inhibitors (ICIs).
Methods: In this single-center retrospective study, we analyzed data from 626 gynecologic cancer patients who received ICIs at our institution between January 2019 and July 2024. Data on the occurrence, grading, organ involvement, management, and potential risk factors of irAEs were collected and analyzed using binary logistic regression.
Results: Of the 626 patients, 136 (21.7%) developed irAEs. The most commonly affected systems were endocrine (11.7%), cardiac (3.2%), and skin (2.6%). The incidence of grade 1– 2 and grade 3– 4 irAEs was 17.7% and 3.99%, respectively. The median time to irAE onset was 9 weeks (after 3 treatment cycles). Binary logistic regression analysis revealed that anti-PD-1/CTLA-4 bispecific antibody was a significant risk factor for irAEs (OR = 2.874, p < 0.0001), whereas a higher number of treatment cycles and combination immunotherapy regimens were protective factors. Most irAEs were managed with intravenous methylprednisolone daily. No irAE-related deaths occurred.
Conclusion: In this cohort of gynecologic cancer patients receiving ICIs, our findings suggest a considerable prevalence of endocrine and cardiac irAEs and identify several treatment-related factors associated with irAE risk. The results may underscore the potential importance of timely glucocorticoid initiation, and could support the consideration of empirical steroid therapy in critically ill patients when diagnostic confirmation is difficult. These findings point to the potential importance of organ-specific monitoring and provide insights that could inform the development of management strategies for this population.
Keywords: immunotherapy, immune-related adverse events, cardiac toxicity, gynecologic cancer, glucocorticoids, methylprednisolone
1Department of Obstetrics and Gynecology, Shengjing Hospital of China Medical University, Shenyang, People’s Republic of China; 2Department of Oncology, Shengjing Hospital of China Medical University, Shenyang, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Xiuqin Li, Email lixq_cmu@163.com Hui Qu, Email quhui@sj-hospital.org
Purpose: This study aimed to characterize the clinical profile, risk factors, and management of immune-related adverse events (irAEs) in patients with gynecologic cancers treated with immune checkpoint inhibitors (ICIs).
Methods: In this single-center retrospective study, we analyzed data from 626 gynecologic cancer patients who received ICIs at our institution between January 2019 and July 2024. Data on the occurrence, grading, organ involvement, management, and potential risk factors of irAEs were collected and analyzed using binary logistic regression.
Results: Of the 626 patients, 136 (21.7%) developed irAEs. The most commonly affected systems were endocrine (11.7%), cardiac (3.2%), and skin (2.6%). The incidence of grade 1– 2 and grade 3– 4 irAEs was 17.7% and 3.99%, respectively. The median time to irAE onset was 9 weeks (after 3 treatment cycles). Binary logistic regression analysis revealed that anti-PD-1/CTLA-4 bispecific antibody was a significant risk factor for irAEs (OR = 2.874, p < 0.0001), whereas a higher number of treatment cycles and combination immunotherapy regimens were protective factors. Most irAEs were managed with intravenous methylprednisolone daily. No irAE-related deaths occurred.
Conclusion: In this cohort of gynecologic cancer patients receiving ICIs, our findings suggest a considerable prevalence of endocrine and cardiac irAEs and identify several treatment-related factors associated with irAE risk. The results may underscore the potential importance of timely glucocorticoid initiation, and could support the consideration of empirical steroid therapy in critically ill patients when diagnostic confirmation is difficult. These findings point to the potential importance of organ-specific monitoring and provide insights that could inform the development of management strategies for this population.
Keywords: immunotherapy, immune-related adverse events, cardiac toxicity, gynecologic cancer, glucocorticoids, methylprednisolone