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德曲妥珠单抗在晚期或转移性乳腺癌治疗中的快速卫生技术评估
Rapid health technology evaluation of trastuzumab deruxtecan in the treatment of advanced or metastatic breast cancer
【摘要】 目的:评价德曲妥珠单抗(trastuzumab deruxtecan, T-DXd)在晚期或转移性乳腺癌治疗中的有效性、安全性和经济性。方法:系统检索中英文数据库及卫生技术评估(health technology assessment, HTA)相关网站,遴选相关研究并提取数据,进行描述性统计分析。结果:共纳入5篇HTA报告、19篇Meta分析/系统综述和14篇经济学研究。在人表皮生长因子受体2(human epidermal growth factor receptor 2,HER2)阳性晚期或转移性乳腺癌的二线治疗中,T-DXd对比恩美曲妥珠单抗(trastuzumab emtansine, T-DM1)有效性更佳。T-DXd常见不良事件包括胃肠道反应、血液毒性、疲劳、脱发等,特殊不良事件主要为间质性肺病。由于药品价格限制,对于中国支付者,T-DXd相比T-DM1和化疗方案均不具成本效益。结论:T-DXd有效性良好、安全性可控,暂不具备经济性。
【Abstract】 Objective: To evaluate the efficacy, safety and pharmacoeconomic of trastuzumab deruxtecan(T-DXd) in the treatment of advanced or metastatic breast cancer. Methods: Databases in Chinese/English and websites on health technology assessment(HTA) were systematically searched. Two reviewers independently identified the studies, extracted data, and accessed the quality. Descriptive statistical analysis was conducted. Results: 5 HTA reports, 19 Meta-analyses/systematic reviews, and 14 economic studies were included. In the second-line treatment of human epidermal growth factor receptor 2 positive advanced or metastatic breast cancer, T-DXd demonstrated superior efficacy compared to trastuzumab emtansine(T-DM1). Common adverse events associated with T-DXd included gastrointestinal reactions, hematologic toxicity, fatigue, and alopecia. Notably, interstitial lung disease was a specific adverse event. Due to drug price restrictions, T-DXd was not cost-effective compared with T-DM1 or chemotherapy for Chinese payers. Conclusion: T-DXd has favorable efficacy and controllable safety, but is not economical at present.
【Key words】 trastuzumab deruxtecan; breast cancer; effectiveness; safety; economy; rapid health technology assessment;
- 【文献出处】 中国新药杂志 ,Chinese Journal of New Drugs , 编辑部邮箱 ,2025年01期
- 【分类号】R737.9
- 【下载频次】67