State Key Laboratory of Oncology in South China, Guangzhou, China.
Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
Front Immunol. 2022 Jul 7;13:874829. doi: 10.3389/fimmu.2022.874829. eCollection 2022.
Immunotherapy has become one of the most important breakthroughs in cancer treatment. Consequently, there have been more immuno-oncology (IO) clinical trials for various cancers in recent decades. However, the quality of such trials in reporting adverse events (AE), especially immune-related AE (irAE), has not been comprehensively evaluated.
We evaluated the harm reporting quality of IO trials. The PubMed, Embase, Cochrane Library, and Web of Science databases were searched to identify all head-to-head phase II and III clinical trials assessing cancer immunotherapy published between January 1, 2010, and December 31, 2021. Publications were assessed using a 16-point harm reporting quality score (HRQS) derived from the 2004 Consolidated Standards of Reporting Trials (CONSORT) extension. The characteristics associated with improved reporting quality were identified with linear regression.
A total of 123 publications were included. The mean HRQS was 11.1 (range, 5-14). The most common poorly reported items were harms addressed in the title (2%), AE collection methodology (3%), the statistical approach for analyzing harms (11%), and the irAE onset patterns and management (adequately reported in 14% and 33% of publications, respectively). The harm information was well described in the publications' Results and Discussion sections (89-99%). The multivariable regression model revealed that higher impact factor (IF) (30<IF<60 vs. IF<30, P=0.021) and phase III clinical trial (phase III vs. phase II, P=0.023) were independent predictors of higher quality score.
Our findings show that AE reporting in IO randomized trials is suboptimal. Efforts should be made to improve harm reporting and to standardize reporting practices. Improvements in AE reporting would permit more balanced assessment of interventions and would enhance evidence-based IO practice.
免疫疗法已成为癌症治疗的最重要突破之一。因此，近几十年来，针对各种癌症的免疫肿瘤学（IO）临床试验越来越多。然而，此类试验在报告不良事件（AE），特别是免疫相关 AE（irAE）方面的质量尚未得到全面评估。
我们评估了 IO 试验的危害报告质量。检索了 PubMed、Embase、Cochrane 图书馆和 Web of Science 数据库，以确定 2010 年 1 月 1 日至 2021 年 12 月 31 日期间发表的所有头对头的 II 期和 III 期评估癌症免疫治疗的临床试验。使用源自 2004 年 CONSORT 扩展的 16 点危害报告质量评分（HRQS）评估出版物。使用线性回归确定与改进报告质量相关的特征。
共纳入 123 篇出版物。平均 HRQS 为 11.1（范围 5-14）。最常报告不佳的项目是标题中涉及的危害（2%）、AE 收集方法（3%）、分析危害的统计方法（11%）和 irAE 发病模式和管理（分别在 14%和 33%的出版物中得到充分报告）。危害信息在出版物的“结果”和“讨论”部分中得到了很好的描述（89-99%）。多变量回归模型显示，较高的影响因子（IF）（30<IF<60 与 IF<30，P=0.021）和 III 期临床试验（III 期与 II 期，P=0.023）是高质量评分的独立预测因素。
我们的研究结果表明，IO 随机试验中的 AE 报告并不理想。应努力改善危害报告并规范报告实践。AE 报告的改进将能够更平衡地评估干预措施，并增强基于证据的 IO 实践。
