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作 者:彭词艳[1] 陈景 李斯妮 李健和[1] 彭六保[1] Ciyan Peng;Jing Chen;Sini Li;Jianhe Li;Liubao Peng(Department of Pharmacy,the Second Xiangya Hospital,Central South University,Changsha 410011,China;Department of Pharmacy,the First Affiliated Hospital of Hunan University of Chinese Medicine,Changsha 410011,China)
机构地区:[1]中南大学湘雅二医院药学部,湖南长沙410011 [2]湖南省中医药大学附属一医院药学部,湖南长沙410011
出 处:《Journal of Chinese Pharmaceutical Sciences》2023年第3期214-222,共9页中国药学(英文版)
摘 要:2015年哌柏西利(Palbociclib)成为首个被FDA批准的CDK4/6选择性小分子酪氨酸激酶抑制剂(TKI)。CDK4/6抑制剂对于晚期HR+/HER2-乳腺癌患者来说,在阻止肿瘤生长、阻止疾病发展和提高存活率方面显示出显著的效果。本研究通过贝叶斯Meta分析和Markov模型评价哌柏西利联用来曲唑对比多西他赛联用表柔比星一线治疗晚期乳腺癌的有效性和经济性。结果显示,多西他赛联用表柔比星对比哌柏西利联用来曲唑治疗晚期HR+/HER2-乳腺癌的无进展生存期(progression-free survival, PFS)为HR=1.8, 95%CI=0.49~5.68, P <0.1,总生存期(Overall Survival, OS)为HR=1.5,95%CI=0.62~5.90, P <0.1;哌柏西利联用来曲唑组获得3.55 LYs,比多西他赛联用表柔比星组增加了0.68 LYs。ICER为91 494元·QALY–1,低于全国的WTP (161 940元·QALY–1),敏感性分析结果与基本分析结果基本一致,说明基础分析结果较为稳定。哌柏西利联用来曲唑对比多西他赛联用表柔比星一线治疗晚期乳腺癌疗效更好,更具有经济性,值得临床关注。In 2015,palbociclib became the first FDA-approved CDK4/6 selective small-molecule tyrosine kinase inhibitor(TKI).CDK4/6 inhibitors have shown significant effects on inhibiting tumor growth,halting disease progression,and improving survival in patients with advanced HR+/HER2-breast cancer.In the present study,we evaluated the effectiveness and affordability of palbociclib in combination with letrozole compared with docetaxel in combination with epirubicin in the first-line treatment of advanced breast cancer by Bayesian analysis and Markov modeling.The results showed that the progression-free survival(PFS)of docetaxel in combination with epirubicin versus palbociclib in combination with letrozole for advanced HR+/HER2-breast cancer was:HR=1.8,95%CI=0.49–5.68,P<0.1,and the overall survival(OS)was:HR=1.5,95%CI=0.62–5.90,P<0.1;3.55 LYs were obtained in the palbociclib combined with letrozole group,with an increase of 0.68 LYs over the docetaxel combined with epirubicin group.The ICER was¥91494 QALY–1,which was lower than the national WTP(¥161940 QALY–1).The results were basically consistent with the results of the primary analysis,indicating that the results of the fundamental analysis were more stable.Palbociclib in combination with letrozole was more effective and economical than docetaxel in combination with epirubicin in the first-line treatment of advanced breast cancer,which deserves clinical attention.
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