报告内容:软组织肉瘤治疗中的严重不良事件-对安慰剂和非系统控制随机试验的30年系统性审查
Rahel Aeschbacher1, Bruno Fuchs1,2,3, Gabriela Studer1,2,4
1Faculty of Health Sciences and Medicine, University of Lucerne, 6002 Lucerne, Switzerland.
Cancers
|October 16, 2025
概括
软组织肉瘤 (STS) 的全身疗法显示中度严重不良事件 (AEs),较新的药物没有降低整体毒性负担. 不一致的AE报告限制了临床试验中的风险效益评估.
科学领域:
- 在瘤学瘤学.
- 临床药理学 临床药理学
- 证据综合 证据综合
背景情况:
- 软组织肉瘤 (STS) 的全身治疗提供了有限的生存益处,但造成了显著的毒性.
- 现有的临床试验报告往往缺乏全面和标准化的不良事件 (AE) 数据.
- 不足够的AE报告阻碍了对STS治疗的准确风险效益评估.
研究的目的:
- 系统地审查和综合随机对照试验 (RCT) 的不良事件 (AE) 数据,评估STS系统疗法.
- 评估与STS不同系统性治疗类别相关的严重副作用的频率和类型.
- 评估发表的STS RCT中AE报告的质量及其对风险效益评估的影响.
主要方法:
- 通过PubMed,CENTRAL和谷歌学者确定RCT进行了PRISMA-2020系统审查.
- 协调AE术语与常用术语对不良事件的标准 (CTCAE) v5.0和规范事件率.
- 使用Cochrane RoB 2工具对聚合比例和评估偏差风险采用随机效应模型.
主要成果:
- 分析了10个涉及2058名患者的RCT;许多试验的毒性数据不完整或缺乏对照组比较.
- 在接受治疗的患者中,重度 (等级≥3) 血液学AE发生在17%的患者中,重度胃肠道AE发生在9%的患者中.
- 严重的副作用的总负担在基于人环素和激酶抑制剂的疗法之间是可比的;较新的药物没有显示出较低的毒性.
结论:
- 严重的副作用在STS系统疗法中很常见,在药物类别中具有不同的特征,但新药的整体负担没有减少.
- 在研究中对AEs的显著异质性和不完整的报告限制了对风险效益评估的信心.
- 未来的STS试验需要标准化的AE报告 (CTCAE v5.0,明确分母,完整的AE矩阵) 进行可靠的评估.
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