Institute of Clinical Pharmacology, Peking University First Hospital, Beijing, China.
Department of Pharmacy, Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences, Tongji Shanxi Hospital, Third Hospital of Shanxi Medical University, Taiyuan, China.
Cancer. 2024 Sep 1;130(17):2968-2977. doi: 10.1002/cncr.35349. Epub 2024 May 4.
Previous studies involving risk-benefit analysis of trastuzumab deruxtecan (DS-8201) have indicated the benefit of this treatment, although it may increase the risk of interstitial lung disease (ILD) and/or pneumonitis in certain patients. This study aimed to assess the safety of DS-8201.
A search was done for relevant articles in four electronic databases: PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov. All reports published up until November 2, 2022, were included, and study types were restricted to clinical trials; the last search was then updated to January 10, 2023. We also assessed the quality of the literature with the Cochrane Handbook for Systematic Reviews of Interventions and the Methodological Index for Non-Randomized Studies tool, and then performed a meta-analysis with R version 4.2.1.
A total of 1428 patients reported in 13 articles were included in this study. The analysis revealed that the most common all-grade treatment-emergent adverse events (TEAEs) were nausea and fatigue. The most common TEAE of grade 3 or above (grade ≥3) was neutropenia. The incidences of ILD and/or pneumonitis for all-grade and grade ≥3 TEAEs were 12.5% and 2.2%, respectively.
This comprehensive summary of the incidence of TEAEs associated with DS-8201 in clinical trials provides an important guide for clinicians. The most common TEAEs were gastrointestinal reactions and fatigue; meanwhile, the most common grade ≥3 TEAE was hematological toxicity. ILD and/or pneumonitis were specific adverse drug reactions associated with DS-8201, of which physicians should be particularly aware for their higher morbidity and rates of grade ≥3 TEAEs.
先前涉及曲妥珠单抗 deruxtecan（DS-8201）风险效益分析的研究表明了这种治疗方法的益处，尽管它可能会增加某些患者发生间质性肺病（ILD）和/或肺炎的风险。本研究旨在评估 DS-8201 的安全性。
在四个电子数据库：PubMed、Embase、Cochrane 图书馆和 ClinicalTrials.gov 中进行了相关文章的检索。纳入截至 2022 年 11 月 2 日发表的所有报告，研究类型仅限于临床试验；然后将最后一次检索更新至 2023 年 1 月 10 日。我们还使用 Cochrane 干预系统评价手册和非随机研究方法学指数工具评估了文献质量，然后使用 R 版本 4.2.1 进行了荟萃分析。
共有 13 篇文章报道的 1428 例患者纳入本研究。分析结果显示，最常见的所有级别治疗后出现的不良事件（TEAEs）是恶心和疲劳。最常见的 3 级或更高级别的 TEAEs 是中性粒细胞减少症。ILD 和/或肺炎的所有级别和 3 级或更高级别的 TEAEs 发生率分别为 12.5%和 2.2%。
本研究综合总结了临床试验中与 DS-8201 相关的 TEAEs 发生率，为临床医生提供了重要指导。最常见的 TEAEs 是胃肠道反应和疲劳；同时，最常见的 3 级或更高级别的 TEAEs 是血液学毒性。ILD 和/或肺炎是与 DS-8201 相关的特定药物不良反应，医生应特别注意其发病率较高和 3 级或更高级别的 TEAEs 发生率较高的情况。
