Treatment-related adverse events of antibody-drug conjugates in clinical trials: A systematic review and meta-analysis

Cancer Innovation Pub Date : 2023-10-15 DOI:10.1002/cai2.97

Jinming Li, Guoshuang Shen, Zhen Liu, Yaobang Liu, Miaozhou Wang, Fuxing Zhao, Dengfeng Ren, Qiqi Xie, Zitao Li, Zhilin Liu, Yi Zhao, Fei Ma, Xinlan Liu, Zhengbo Xu, Jiuda Zhao

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Abstract

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%; I² = 89%) and the incidence of grade ≥ 3 treatment-related AEs was 6.2% (95% CI: 3.0%–12.4%; I² = 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.

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临床试验中抗体-药物偶联物的治疗相关不良事件：系统综述和荟萃分析

背景抗细菌偶联物（ADC）的广泛应用正在改变癌症治疗的格局。了解ADC的治疗相关不良事件（AE）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ADC在治疗实体瘤和血液系统恶性肿瘤中的应用相关的AE的概况和发生率。方法检索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。所有等级和等级的总体轮廓和发生率≥ 3例治疗相关AE是分析的主要结果。结果本研究共纳入138项试验，涉及15473名患者。任何级别治疗相关AE的总发生率为100.0%（95%置信区间[CI]:99.9%-100.0%；I2 = 89%）和分级的发生率 ≥ 3例治疗相关AE为6.2%（95%CI:3.0%-12.4%；I² = 99%）。结论本研究对癌症治疗中与ADC相关的AE进行了全面综述。ADC的使用导致任何级别AE的高发生率，但级别AE的低发生率 ≥ 3例AE。AE特征和发病率因癌症类型、ADC类型和ADC成分而异。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Cancer Innovation

CiteScore

0.70

自引率

0.00%

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