Background: Immune checkpoint inhibitors (ICIs) have emerged as an essential therapeutic approach in treating many solid tumors. ICIs enhance the body’s anti-tumor T-cell activity, resulting in a novel spectrum of immunotherapy-related side effects. This novel spectrum of adverse events differs significantly from the side effects of conventional chemotherapy. It, therefore, requires special attention in the diagnosis and management of immunotherapy-related adverse events (irAEs). The present study aimed to retrospectively analyze the incidence, diagnosis, and management of irAEs in patients with gynecologic malignancies who received ICIs and to discuss these findings in the context of the recent literature. Methods: In the present retrospective overview, we evaluated patients with gynecologic malignancies (breast, endometrial, cervical, ovarian) who received ICIs with regard to the incidence, type, and time to onset of irAEs. A total of 61 patients treated at the Department of Gynecology and Obstetrics, University Medical Center Mainz, Germany, between 2018 and 2023 were included in the analysis. Results: A total of 32.8% of patients developed an irAE of any grade or type. The median time to irAE was 24 weeks. The most frequently observed irAEs were grade 1 (20%) or 2 (35%). Immunotherapy-related grade 3 or 4 adverse events occurred in 45% of patients (40% grade 3, 5% grade 4). The most common type of irAE in our cohort was hypothyroidism, followed by hepatitis and colitis. Cox regression analysis identified the duration of ICI therapy as the only significant factor influencing the incidence of irAEs (p= 0.004). Conclusion: The broad spectrum of irAEs and the onset time of irAEs are important challenges of therapy with ICIs, requiring proactive monitoring and tailored management strategies to optimize the safety and efficacy of immunotherapy.
背景：免疫检查点抑制剂已成为治疗多种实体肿瘤的重要疗法。该类药物通过增强机体抗肿瘤T细胞活性，引发一系列新型免疫治疗相关不良反应。这类新型不良事件谱与传统化疗的副作用存在显著差异，因此在免疫治疗相关不良事件的诊断和管理中需要特别关注。本研究旨在回顾性分析接受免疫检查点抑制剂治疗的妇科恶性肿瘤患者中免疫治疗相关不良事件的发生率、诊断及管理情况，并结合最新文献对研究结果进行探讨。 方法：本回顾性研究评估了接受免疫检查点抑制剂治疗的妇科恶性肿瘤（乳腺癌、子宫内膜癌、宫颈癌、卵巢癌）患者免疫治疗相关不良事件的发生率、类型及发生时间。研究纳入了2018年至2023年间在德国美因茨大学医学中心妇产科接受治疗的61例患者。 结果：共有32.8%的患者出现任何级别或类型的免疫治疗相关不良事件。免疫治疗相关不良事件发生的中位时间为24周。最常见的不良事件为1级（20%）和2级（35%）。3级或4级免疫治疗相关不良事件发生率为45%（其中3级40%，4级5%）。本队列中最常见的免疫治疗相关不良事件类型为甲状腺功能减退，其次为肝炎和结肠炎。Cox回归分析显示，免疫检查点抑制剂治疗持续时间是影响免疫治疗相关不良事件发生率的唯一显著因素（p=0.004）。 结论：免疫治疗相关不良事件的广泛性和发生时间是免疫检查点抑制剂治疗面临的重要挑战，需要采取主动监测和个体化管理策略，以优化免疫治疗的安全性和有效性。
肿瘤(癌症)患者之家