Zhang Qi, Chen Jialing, Tsai Nana, Zhu Xuejuan, Zhao Minyan, Meng Lirong, Fong Pedro
Department of Nursing, The Second Affiliated Hospital of Soochow University, Suzhou, China.
Faculty of Health Science and Sports, Macao Polytechnic University, Macao, China.
Sci Rep. 2024 Dec 28;14(1):30983. doi: 10.1038/s41598-024-82105-3.
Immune checkpoint inhibitors (ICIs) have been approved for monotherapy and combined therapy with chemotherapy and/or radiotherapy in China since 2018. The number of patients receiving ICIs has significantly increased in recent years, and the collection and analysis of this data are crucial for a comprehensive understanding of their clinical outcomes and adverse effects. The effects of ICIs may vary among different ethnic groups, and there is a lack of such data in the Chinese population. This study aimed to investigate the occurrence rate of various types of immune-related adverse events (irAEs) of ICIs in cancer survivors with different types of cancer and explore the associated risk factors. Demographic data, cancer type, dosage, Eastern Cooperative Oncology Group Performance Score (ECOG-PS), and details of irAEs were collected from 120 participants who underwent ICI treatment. Descriptive statistics were used to summarise the patient population characteristics, while t-tests and Chi-square tests assessed associations between variables. Multiple logistic regression evaluated the relationships between independent variables and the likelihood of experiencing irAEs. The results indicated that the occurrence of less severe G1 and G2 irAEs was 25%, while more severe G3 to G5 irAEs accounted for 5.8% of the total. Among the irAEs, skin toxicity had the highest incidence rate (14.2%), followed by gastrointestinal toxicity (6.7%), and endocrine toxicity had the lowest incidence rate of 2.5%. The multiple logistic regression model revealed that patients with ECOG-PS ≥ 2 are over five times more likely to experience irAEs compared to those with lower ECOG-PS (OR: 5.03, 95% CI: 1.05-24.17). Additionally, patients with cancer stage IV have 11.47 times the odds of experiencing irAEs (OR: 11.47, 95% CI: 1.05-24.17). In conclusion, a substantial proportion of patients receiving ICIs experienced irAEs. Patients with an ECOG-PS score of ≥ 2 and advanced cancer stage are at increased risk for these events, necessitating close monitoring by healthcare professionals. The identification of skin and gastrointestinal toxicities as the most common irAEs revealed the need for targeted education for the patients and their carers to recognise and manage these issues. Furthermore, our findings, in conjunction with existing literature, may guide future research on predictive modelling for high-risk patients receiving ICIs.
自2018年以来,免疫检查点抑制剂(ICIs)在中国已被批准用于单药治疗以及与化疗和/或放疗联合治疗。近年来,接受ICIs治疗的患者数量显著增加,收集和分析这些数据对于全面了解其临床疗效和不良反应至关重要。ICIs的疗效在不同种族群体中可能有所不同,而中国人群中缺乏此类数据。本研究旨在调查不同类型癌症幸存者中ICIs各类免疫相关不良事件(irAEs)的发生率,并探索相关危险因素。从120名接受ICI治疗的参与者中收集了人口统计学数据、癌症类型、剂量、东部肿瘤协作组体能状态评分(ECOG-PS)以及irAEs的详细信息。使用描述性统计来总结患者群体特征,同时采用t检验和卡方检验评估变量之间的关联。多元逻辑回归评估自变量与发生irAEs可能性之间的关系。结果表明,较轻的G1和G2级irAEs的发生率为25%,而较严重的G3至G5级irAEs占总数的5.8%。在irAEs中,皮肤毒性的发生率最高(14.2%),其次是胃肠道毒性(6.7%),内分泌毒性的发生率最低,为2.5%。多元逻辑回归模型显示,ECOG-PS≥2的患者发生irAEs的可能性是ECOG-PS较低患者的五倍多(比值比:5.03,95%置信区间:1.05 - 24.17)。此外,癌症IV期患者发生irAEs的几率是前者的11.47倍(比值比:11.47,95%置信区间:1.05 - 24.17)。总之,相当一部分接受ICIs治疗的患者发生了irAEs。ECOG-PS评分≥2且癌症分期较晚的患者发生这些事件的风险增加,医护人员需要密切监测。确定皮肤和胃肠道毒性是最常见的irAEs表明,需要对患者及其护理人员进行针对性教育,以识别和处理这些问题。此外,我们的研究结果与现有文献相结合,可能会为未来针对接受ICIs治疗的高危患者的预测模型研究提供指导。