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

抗体药物偶联物临床试验中治疗相关不良事件:系统评价和荟萃分析

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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%; I (2) = 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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