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帕妥珠单抗治疗HER2阳性乳腺癌的快速卫生技术评估

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目的 对帕妥珠单抗治疗人表皮生长因子受体(human epidermal growth factor receptor,HER)2阳性乳腺癌的安全性、有效性及经济性进行快速卫生技术评估(health technology assessment,HTA),为临床药物的遴选提供循证依据.方法 系统检索PubMed、Cochrane Library、Embase、中国知网、万方以及各国HTA官方网站.根据纳入和排除标准筛选文献,经数据提取和质量评价对结果进行描述性分析.结果 共纳入系统评价/meta分析20篇,经济学研究12篇,HTA4篇.研究结果表明,有效性方面,针对新辅助治疗的乳腺癌患者,帕妥珠单抗可提高曲妥珠单抗的疾病缓解率(pathologic conplete remission,pCR)和客观缓解率(objective remission rate,ORR)、曲妥珠单抗+化疗的pCR和无病生存期(disease free survival,DFS).针对转移性乳腺癌患者,帕妥珠单抗可提高曲妥珠单抗的无进展生存期(progression free survival,PFS)、曲妥珠单抗+紫杉醇的PFS、ORR、1年、2年和中位生存期(overall survival,OS)以及曲妥珠单抗+卡培他滨的OS.安全性方面,帕妥珠单抗不良反应较轻,安全性较好.经济性方面,无论是国内还是国外,加入帕妥珠单抗均不具有经济性.结论 帕妥珠单抗治疗HER2阳性乳腺癌的有效性、安全性较好,但经济性较差.
Pertuzumab for the treatment of HER2-positive breast cancer:a rapid health technology assessment
Objective To perform a rapid health technology assessment(rHTA)on the safety,effectiveness,and economy of pertuzumab in human epidermal growth factor receptor(HER)2-positive breast cancer,and to provide an evidence-based basis for clinical drug decision.Methods Pubmed,Cochrane Library,Embase,CNKI,Wanfang,official HTA websites were systematically searched.References were screened according to the inclusion and exclusion criterion.And the results were analyzed by data extraction and quality evaluation.Results 20 systematic review/meta-analysis,12 economic studies and 4 HTA were included in our study.The results of the study showed that in terms of effectiveness,pertuzumab can improve the pathologic conplete remission(pCR)and objective remission rate(ORR)of trastuzumab,pCR and disease free survival(DFS)of trastuzumab plus chemotherapy for neoadjuvant breast cancer patients.For the patients with metastatic breast cancer,pertuzumab can improve the progression-free survival(PFS)of trastuzumab,PFS,ORR,1-year,2-year and median overall survival(OS)of trastuzumab plus taxol,the OS of trastuzumab plus capecitabine.In terms of safety,pertuzumab had mild side effects and good safety.In terms of economy,the combination of pertuzumab was not economical both in abroad and at home.Conclusion Pertuzumab was effective and safe in the treatment of HER2-positive breast cancer,but the economy was poor.

pertuzumabhuman epidermal growth factor receptor 2-positive breast cancerrapid health technology assessmenteffectivenesssafetyeconomy

纪汶君、商杨婕、门鹏、吴慧、马莹

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泰州市人民医院药学部,江苏泰州 225300

北京大学医学部药物评价中心,北京 100191

盐城市第一人民医院药学部,江苏盐城 224000

帕妥珠单抗 HER2阳性乳腺癌 快速卫生技术评估 有效性 安全性 经济性

江苏省药学会——天晴医院药学基金

Q202049

2024

世界临床药物
上海医药工业研究院

世界临床药物

CSTPCD
影响因子:0.849
ISSN:1672-9188
年,卷(期):2024.45(3)
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