阿贝西利治疗激素受体阳性/人表皮生长因子受体2阴性晚期/转移性乳腺癌的快速卫生技术评估#br#

摘要/Abstract

摘要： 目的：评价阿贝西利(ABE)用于治疗激素受体阳性(HR+)/人表皮生长因子受体2阴性( HER2-)晚期/转移性乳腺癌的有效性、安全性和经济性。方法：通过检索CNKI、万方、PubMed、Embase等中英文数据库，由2位评价者分别根据纳入与排除标准进行文献筛选和分析。结果：共纳入2篇卫生技术评估(HTA) 报告、12 篇SR/Meta分析、7篇经济学研究。在HR+ /HER2-晚期或转移性乳腺癌的治疗中，有效性和安全性方面，与内分泌治疗(ET)相比，ABE联合ET均可显著改善患者的无进展生存期(PFS)，肿瘤客观缓解率(ORR)，但增加了血液系统，胃肠道，静脉血栓等不良反应发生风险，且与同类药物哌柏西利(PAL)，瑞博西尼(RIB)相比疗效和安全性相当。在经济性方面，大部分结果表明，ABE+ET与单独ET或其他同类药物相比，不具有成本效果优势。结论：ABE用于HR+/HER2-晚期或转移性乳腺癌具有良好的有效性和安全性，但在经济学方面并无明显的优势。

关键词: 阿贝西利, 晚期/转移性乳腺癌, 快速卫生技术评估, 成本效果

Abstract: Objective： To evaluate the efficacy， safety and economy of Abemaciclib (ABE) in the treatment of hormone receptor positive (HR+)/human epidermal growth factor receptor-2-negative (HER2-) metastatic/advanced breast cancer. Methods： By searching CNKI， Wanfang， PubMed， Embase and other Chinese and English databases， two reviewers were selected and analyzed according to inclusion and exclusion criteria respectively. Results： A total of 2 Health Technology assessment (HTA) reports， 12 SR/meta-analyses， and 7 economic studies were included. In the treatment of HR+ /HER2-advanced or metastatic breast cancer， in terms of efficacy and safety， compared with ET， ABE combined with endocrine therapy (ET) can significantly improve patients′ progression-free survival (PFS) and tumor objective response rate (ORR)， but increase the risk of adverse reactions such as blood system， gastrointestinal tract and venous thrombosis， and compared with the similar drugs Palbociclib (PAL)， Ribociclib(RIB)， the efficacy and safety is comparable. In terms of economics， most results suggest that ABE+ET does not have a cost-effectiveness advantage over ET alone or other drugs of the same class. Conclusion： ABE has a good efficacy and acceptable safety profile in HR+ /HER2-advanced or metastatic breast cancer， but no significant economic advantages.

Key words: Abemaciclib, Advanced / metastatic breast cancer, Rapid health technology assessment, Cost-effectiveness

中图分类号:

普艳姣1, 李辉1, 段雪玉1, 陈伟1, 张婷1, 王学昌2. 阿贝西利治疗激素受体阳性/人表皮生长因子受体2阴性晚期/转移性乳腺癌的快速卫生技术评估#br#[J]. 中国药物评价, 2024, 41(1): 71-77.

PU Yan-jiao1, LI Hui1, DUAN Xue-yu1, CHEN Wei1, ZHANG Ting1, WANG Xue-chang2. Rapid Health Technology Assessment Abemaciclib in the Treatment of Hormone Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative Advanced /Metastatic Breast Cancer[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2024, 41(1): 71-77.

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