曲妥珠单抗生物类似药治疗HER2阳性晚期乳腺癌的安全性、有效性和经济性评价  

Safety,Efficacy,and Economic Evaluation of Trastuzumab Biosimilars in the Treatment of HER2-Positive Advanced Breast Cancer

作　　者：谢梦棋 王佳惠 赖春花 李阿玲[4] 刘丽娟[4] 潘丽莉 廖瑜倩 郭宇玲[5] 陈璿瑛[5] 胡锦芳[5] XIE Mengqi;WANG Jiahui;LAI Chunhua;LI Aling;LIU Lijuan;PAN Lili;LIAO Yuqian;GUO Yuling;CHEN Xuanying;HU Jinfang(Shaoxing Keqiao District Maternal and Child Health Hospital,Shaoxing,Zhejiang,China 312030;School of Pharmacy,Nanchang University,Nanchang,Jiangxi,China 330006;The Third Hospital of Nanchang City,Nanchang,Jiangxi,China 330006;Jiangxi Cancer Hospital of Nanchang University,Nanchang,Jiangxi,China 330006;The First Affiliated Hospital of Nanchang University,Nanchang,Jiangxi,China 330006)

机构地区：[1]浙江省绍兴市柯桥区妇幼保健院,浙江绍兴312030 [2]南昌大学药学院,江西南昌330006 [3]江西省南昌市第三医院,江西南昌330006 [4]江西省肿瘤医院,江西南昌330006 [5]南昌大学第一附属医院,江西南昌330006

出　　处：《中国药业》2024年第23期123-128,共6页China Pharmaceuticals

基　　金：国家自然科学基金[82060679];江西省卫生健康委员会科技计划项目[SKJP220212447];江西省重点研发计划项目[20202BBGL73038];吴阶平医学基金会临床科研专项资助基金项目[320.6750.2022-19-13]。

摘　　要：目的比较曲妥珠单抗生物类似药(商品名汉曲优)与原研药(商品名赫赛汀)治疗人表皮生长因子受体2(HER2)阳性乳腺癌患者的安全性、有效性和经济性。方法回顾性分析2020年8月至2022年12月在南昌大学第一附属医院、江西省肿瘤医院和江西省南昌市第三医院接受曲妥珠单抗联合紫杉醇化学治疗的56例HER2阳性晚期乳腺癌患者的临床资料,按治疗方案的不同将患者分为观察组(22例,予汉曲优)和对照组(34例,予赫赛汀),比较两组患者用药后的疗效、不良反应和治疗费用。结果有效性方面,观察组和对照组的中位无进展生存期分别为15.8个月[95%CI(7.34,24.27)]和12.5个月[95%CI(8.72,16.31)],组间无显著差异(P=0.466);客观缓解率分别为54.55%和52.94%,组间无显著差异(P=0.906);疾病控制率分别为90.91%和88.24%,组间无显著差异(P=1.000)。安全性方面,观察组和对照组不良反应发生率相当(83.36%比73.53%,P=0.418)。经济性方面,观察组患者医疗总费用中位数为13991.08元,少于对照组的17553.69元,但无显著差异(P=0.131)。结论汉曲优与赫赛汀的有效性、安全性及经济性相当,但汉曲优具有规格优势,医师可根据患者的用药剂量选择合适的药物。Objective To compare the safety,efficacy,and economics of the trastuzumab biosimilar Zercepac(HLX02)versus the original drug Herceptin in the treatment of patients with human epidermal growth factor receptor 2(HER2)-positive breast cancer.Methods The clinical data of 56 HER2-positive advanced breast cancer patients who received trastuzumab combined with paclitaxel chemotherapy in the First Affiliated Hospital of Nanchang University,Jiangxi Cancer Hospital and the Third Hospital of Nanchang City from August 2020 to December 2022 were retrospectively analyzed.The patients were divided into the observation group(n=22,treated with HLX02)and the control group(n=34,treated with Herceptin)according to different treatment schemes,and the efficacy,adverse reactions and medical cost in the two groups were compared.Results In terms of efficacy,the median progression-free survival in the observation group was 15.8 months[95%CI(7.34,24.27)],which was not significantly different from 12.5 months[95%CI(8.72,16.31)]in the control group(P=0.466);the objective remission rate in the observation group was 54.55%,which was not significantly different from 52.94%in the control group(P=0.906);the disease control rate in the observation group was 90.91%,which was not significantly different from 88.24%in the control group(P=1.000).In terms of safety,the incidence of adverse reactions between the observation group and the control group was comparable(83.36%vs.73.53%,P=0.418).In terms of economics,the median total medical cost in the observation group was CNY 13991.08,which was lower than CNY 17553.69 in the control group,but there was no significant difference(P=0.131).Conclusion The efficacy,safety,and economics of HLX02 and Herceptin are comparable.But HLX02 has a specification advantage,and physicians can choose the appropriate drug based on the patient′s dosage.

关 键 词：曲妥珠单抗 人表皮生长因子受体2阳性乳腺癌 有效性 安全性 经济性 

分 类 号：R95[医药卫生—药学] R979.1