临床试验中抗体药物偶联物的治疗相关不良事件：一项系统评价和荟萃分析。
Treatment-related adverse events of antibody-drug conjugates in clinical trials: A systematic review and meta-analysis.
作者信息
Li Jinming, Shen Guoshuang, Liu Zhen, Liu Yaobang, Wang Miaozhou, Zhao Fuxing, Ren Dengfeng, Xie Qiqi, Li Zitao, Liu Zhilin, Zhao Yi, Ma Fei, Liu Xinlan, Xu Zhengbo, Zhao Jiuda
机构信息
Breast Disease Diagnosis and Treatment Center Affiliated Hospital of Qinghai University, Affiliated Cancer Hospital of Qinghai University Xining Qinghai China.
Qinghai Provincial Clinical Research Center for Cancer; Qinghai Provincial Institute of Cancer Research Xining Qinghai China.
出版信息
Cancer Innov. 2023 Oct 15;2(5):346-375. doi: 10.1002/cai2.97. eCollection 2023 Oct.
BACKGROUND
The wide use of antibody-drug conjugates (ADCs) is transforming the cancer-treatment landscape. Understanding the treatment-related adverse events (AEs) of ADCs is crucial for their clinical application. We conducted a meta-analysis to analyze the profile and incidence of AEs related to ADC use in the treatment of solid tumors and hematological malignancies.
METHODS
We searched the PubMed, Embase, and Cochrane Library databases for articles published from January 2001 to October 2022. The overall profile and incidence of all-grade and grade ≥ 3 treatment-related AEs were the primary outcomes of the analysis.
RESULTS
A total of 138 trials involving 15,473 patients were included in this study. The overall incidence of any-grade treatment-related AEs was 100.0% (95% confidence interval [CI]: 99.9%-100.0%; = 89%) and the incidence of grade ≥ 3 treatment-related AEs was 6.2% (95% CI: 3.0%-12.4%; ² = 99%).
CONCLUSIONS
This study provides a comprehensive overview of AEs related to ADCs used for cancer treatment. ADC use resulted in a high incidence of any-grade AEs but a low incidence of grade ≥ 3 AEs. The AE profiles and incidence differed according to cancer type, ADC type, and ADC components.
背景
抗体药物偶联物（ADCs）的广泛应用正在改变癌症治疗格局。了解ADCs的治疗相关不良事件（AEs）对其临床应用至关重要。我们进行了一项荟萃分析，以分析与ADCs用于治疗实体瘤和血液系统恶性肿瘤相关的不良事件的特征和发生率。
方法
我们检索了PubMed、Embase和Cochrane图书馆数据库中2001年1月至2022年10月发表的文章。分析的主要结果是所有级别的和≥3级治疗相关不良事件的总体特征和发生率。
结果
本研究共纳入138项试验，涉及15473例患者。任何级别的治疗相关不良事件的总体发生率为100.0%（95%置信区间[CI]：99.9%-100.0%；I²=89%），≥3级治疗相关不良事件的发生率为6.2%（95%CI：3.0%-12.4%；I²=99%）。
结论
本研究全面概述了与用于癌症治疗的ADCs相关的不良事件。使用ADCs导致任何级别的不良事件发生率较高，但≥3级不良事件的发生率较低。不良事件的特征和发生率因癌症类型、ADCs类型和ADCs成分而异。
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