基于真实世界数据分析马来酸吡咯替尼治疗HER-2阳性转移性乳腺癌的有效性及经济性  

Efficacy and pharmacoeconomic evaluations of pyrotinib in the treatment of HER-2 positive metastatic breast cancer based upon real world data

作　　者：耿亚迪 刘含韵 吴颖其 颜辉 余翠翠 宁丽娟 朱鹏里 陈泳伍 吴菲[1,2] 沈爱宗 GENG Yadi;LIU Hanyun;WU Yingqi;YAN Hui;YU Cuicui;NING Lijuan;ZHU Pengli;CHEN Yongwu;WU Fei;SHEN Aizong(Department of Pharmacy,First Affiliated Hospital,Division of Life Sciences&Medicine,University of Science and Technology of China,Anhui Hefei 230001,China;Technology of China/Anhui Technology Center for Clinical Comprehensive Evaluation of Drugs,Anhui Hefei 230001,China;School of Management,University of Science&Technology of China,Anhui Hefei 230001,China)

机构地区：[1]中国科学技术大学附属第一医院(安徽省立医院)药学部,安徽合肥230001 [2]安徽省药品临床综合评价技术中心,安徽合肥230001 [3]中国科学技术大学管理学院,安徽合肥230001

出　　处：《中国医院药学杂志》2024年第10期1179-1183,共5页Chinese Journal of Hospital Pharmacy

摘　　要：目的:分析吡咯替尼对比拉帕替尼分别联合其他抗肿瘤药物治疗人表皮生长因子受体-2(HER-2)阳性转移性乳腺癌的有效性及经济性。方法:回顾性纳入中国科学技术大学附属第一医院(安徽省立医院)2018年1月至2023年1月使用拉帕替尼(对照组)或吡咯替尼(观察组)的HER-2阳性转移性乳腺癌患者,收集患者基本信息、临床疗效及住院成本信息。比较2组的无进展生存期(PFS)、有效率(RR)及疾病控制率(DCR),并以PFS为产出指标,计算增量成本效果比(ICER)。结果:2组患者的年龄、病理类型、病理分期及治疗方案均无显著性差异,效果方面,两组的PFS分别为3.16个月(拉帕替尼组)及6.67个月(吡咯替尼组)(P<0.05);2组RR及DCR均无显著性差异;成本方面,2组的平均总住院成本分别为78500.51元(拉帕替尼组)及144094.66元(吡咯替尼组);吡咯替尼组对比拉帕替尼组的ICER为18687.79元/月。单因素敏感性分析表明,吡咯替尼组住院费用对结果的影响较大;概率敏感性结果表明,当意愿支付阈值(WTP)为32600元/月时,吡咯替尼组和拉帕替尼组具有经济性的概率各为50%。结论:吡咯替尼组的治疗效果优于拉帕替尼组,成本效果分析结果表明,当患者的WTP大于18687.79元/月时,吡咯替尼更具有经济性。OBJECTIVE To explore the efficacies and economics of pyrotinib versus lapatinib plus other anti-tumor agents for HER-2(human epidermal growth factor receptor-2)positive metastatic breast cancer.METHODS From January 2018 to January 2023,HER-2 positive patients of advanced breast cancer on a therapy of lapatinib or pyrotinib at First Affiliated Hospital of USTC were retrospectively reviewed.They were assigned into two groups of lapatinib and pyrotinib.Basic profiles,clinical outcomes and hospitalization expense were recorded.Progression-free survival(PFS),response rate(RR)and disease control rate(DCR)of two groups were compared.And PFS was utilized as an output index for calculating the value of incremental cost-effectiveness ratio(ICER).RESULTS No significant inter-group differences existed in age,pathological type,pathological stage or treatment regimen.The median PFS of two groups was 3.16 months in lapatinib group and 6.67 months in pyrotinib group(P<0.05).No significant inter-group difference existed in RR or DCR.Mean total hospitalization expenses were 78500.51 yuan(lapatinib group)and 144094.66 yuan(pyrotinib group)respectively.ICER of pyrotinib versus lapatinib was 18687.79 yuan per month.One-way Sensitivity analysis revealed that hospitalization expense had a greater impact on the results in pyrotinib group.Probabilistic sensitivity analysis indicated that,at a threshold of willingness-to-pay(WTP)>32600 yuan/month,the probability of cost-effective of pyrotinib group and lapatinib group was 50%each.CONCLUSION The treatment efficacy of pyrotinib group is better than that of lapatinib group.Cost-effectiveness analysis revealed that when WTP is greater than 18687.79 yuan/month,pyrotinib is a cost-effective alternative therapy for HER-2 positive metastatic breast cancer.

关 键 词：吡咯替尼 拉帕替尼 乳腺癌 真实世界 无进展生存期 成本效果分析 

分 类 号：R737.9[医药卫生—肿瘤]