一线化疗联合贝伐珠单抗治疗晚期非小细胞肺癌的真实世界研究  

Real-world study of first-line chemotherapy in combination with bevacizumab for advanced non-small cell lung cancer

作　　者：王冰[1] 王雨廷 李进峰 刘飞 王颖[1] 陈维娜 董浩贞 张媛[1] 孙铜 WANG Bing;WANG Yuting;LI Jinfeng;LIU Fei;WANG Ying;CHEN Weina;DONG Haozhen;ZHANG Yuan;SUN Tong(Department of Pharmacy,Weihai Municipal Hospital,Cheeloo College of Medicine,Shandong University,Weihai 264200,China;Shandong Center for Food and Drug Evaluation&Inspection,Jinan 250022,China;Shandong Institute for Food and Drug Control,Jinan 250101,China)

机构地区：[1]山东大学附属威海市立医院,山东威海264200 [2]山东省食品药品审评查验中心,山东济南250022 [3]山东省食品药品检验研究院,山东济南250101

出　　处：《药学研究》2025年第3期289-295,共7页Journal of Pharmaceutical Research

基　　金：2021年度山东省医学会临床科研资金项目(No.YXH2022ZX02054)。

摘　　要：目的比较国产生物类似药贝伐珠单抗注射液(安可达)与原研药贝伐珠单抗注射液(安维汀)在治疗晚期非小细胞肺癌患者中的疗效及安全性。方法选择2020年1月至2021年12月于威海市立医院就诊的肺癌患者,对符合纳入标准的患者进行筛选得到66例,其中化疗方案培美曲塞+铂类+贝伐珠单抗(安维汀)为对照组,共28例;培美曲塞+铂类+贝伐珠单抗(安可达)为试验组,共38例。把第12周客观缓解率(ORR)作为主要终点,而18周客观缓解率(ORR)、24周客观缓解率(ORR)、缓解持续时间(DOR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS)、安全性评估作为次要终点。结果在66名患者的生存函数显示安可达组与安维汀组对患者的生存时间影响未见显著性差异(P>0.05)。COX单因素回归分析,性别、年龄、吸烟史、肿瘤分期以及肿瘤转移部位等因素与PFS、OS均未见显著性关联(P>0.05)。主要研究终点第12周ORR:安维汀组是32.14%,安可达组是65.79%,P=0.007;次要研究终点第18周ORR:安维汀组是21.43%,安可达组是44.74%,P=0.05;第24周ORR:安维汀组是14.29%,安可达组是23.68%,P值是0.343。安维汀组随访结束时ORR 3.57%,DCR 14.29%;安可达组随访结束时ORR 15.79%,DCR 5.26%,两组数据差异无统计学意义(P>0.05)。不良反应共24例,且安可达组与安维汀组发生不良反应的情况差异无统计学意义。结论贝伐珠单抗注射液(安可达)在治疗晚期非小细胞肺癌中,有较好的临床疗效及生存获益,不良反应可控、可耐受,临床有效性及安全性较参照药贝伐珠单抗注射液(安维汀)差异无统计学意义。Objective To compare the safety and efficacy of domestic biological analogue Bevacizumab Injection(Ankeda)and the original research drug Bevacizumab Injection(Avastin)in the treatment of advanced non-small cell lung cancer patients.Methods Total of 66 patients with advanced non-small cell lung cancer admitted to Weihai Municipal Hospital from January 2020 to December 2021 were selected,of which 28 patients were treated with the chemotherapy regimen pemetrexed+platinum+bevacizumab(Avastin)as the control group and the chemotherapy regimen was pemetrexed+platinum+bevacizumab(Ankeda)as the experimental group,with a total of 38 cases.The objective response rate(ORR)at week 12 was used as the primary endpoint,while objective response rates(ORR)at week 18,24,duration of response(DOR),disease control rate(DCR),progression free survival(PFS),overall survival(OS),and safety assessment were used as secondary endpoints.Results In the survival function of 66 patients,there was no significant difference in the effect of time to survival between the Ankeda and Avastin groups(P>0.05),and no significant association was found between sex,age,smoking history,tumor stage and metastatic site on PFS and OS in the COX one-way regression analysis(P>0.05).The main endpoint of the 12th week ORR study was 32.14% in the Avastin group and 65.79% in the Ankeda group(P=0.007);The ORR of the secondary study endpoint at week 18 was 21.43% in the Avastin group and 44.74% in the Ankeda group(P=0.05);The ORR for the 24th week was 14.29% in the Avastin group and 23.68% in the Ankeda group(P=0.343).The patients in the Avastin group had an ORR of 3.57% and a DCR of 14.29% at the end of follow-up。And at the end of follow-up,patients in the Ankeda group had an ORR of 15.79% and a DCR of 5.26%,with no statistically significant difference between the two groups(P>0.05).Among the 66 patients,there were 24 cases of adverse reactions.And there was no statistically significant difference between the occurrence of adverse reactions in the Ankeda and Avastin

关 键 词：非小细胞肺癌 贝伐珠单抗注射液 化疗 生物类似药 原研药 

分 类 号：R734.2[医药卫生—肿瘤]