维迪西妥单抗治疗晚期实体肿瘤的有效性和安全性研究  

Efficacy and Safety of Vedicetuzumab in the Treatment of Advanced Solid Tumors

作　　者：杨婧[1] 严冬 高芸菲[1] 程瑜蓉 吴磊 YANG Jing;YAN Dong;GAO Yunfei;CHENG Yurong;WU Lei(Cancer Center,Beijing Luhe Hospital,Capital Medical University,Beijing 101100,China)

机构地区：[1]首都医科大学附属北京潞河医院肿瘤中心,北京101100

出　　处：《中国医院用药评价与分析》2023年第7期773-775,779,共4页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：北京市自然科学基金面上项目(No.7232085)。

摘　　要：目的:探讨维迪西妥单抗治疗晚期实体肿瘤的有效性和安全性。方法:选取2021年7月至2022年12月该院收治的20例人表皮生长因子受体2(HER2)表达的晚期实体瘤患者,所有患者均经一线或以上治疗后病情进展,单独使用注射用维迪西妥单抗进行治疗,评估患者的客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS)和不良反应发生情况。结果:随访时间为1.5~15个月,中位随访时间为14个月。共入组20例患者,ORR为35%(7例),DCR为80%(16例),中位PFS为5.0个月。根据既往是否使用抗HER2治疗进行分组比较,两组患者中位PFS的差异无统计学意义(P=0.693)。根据HER2过/低表达分组,两组患者中位PFS的差异无统计学意义(P=0.280)。不良反应以1—2级为主,≥3级不良反应发生率为5%(1/20)。结论:对于HER2表达晚期实体肿瘤患者,无论既往是否使用抗HER2治疗,单独使用注射用维迪西妥单抗的,疗效相当;对于HER2过表达或低表达患者,单独使用注射用维迪西妥单抗的疗效相当;注射液维迪西妥单抗在HER2表达晚期实体肿瘤中应用的安全性较好。OBJECTIVE:To probe into the efficacy and safety of vedicetuzumab in the treatment of advanced solid tumors.METHODS:Twenty patients with advanced human epidermal growth factor receptor 2(HER2)-expressing solid tumor admitted into the hospital from Jul.2021 to Dec.2022 were extracted.All patients progressed after first-line treatment or above,and were treated with vidicetuzumab for injection alone.Objective response rate(ORR),disease control rate(DCR),progression-free survival(PFS),overall survival(OS)and adverse drug reactions were evaluated.RESULTS:Follow-up time was 1.5 to 15 months,and median follow-up time was 14 months.A total of 20 patients were enrolled,the ORR was 35%(7 cases),the DCR was 80%(16 cases)and the median PFS was 5.0 months.There was no significant difference in median PFS between two groups based on whether or not be treated with anti-HER2(P=0.693).There was no significant difference in median PFS between groups based on HER2 over/under expression(P=0.280).The majority of adverse drug reactions were grade 1 to 2,and the incidence of adverse drug reactions≥grade 3 was 5%(1/20).CONCLUSIONS:For HER2-positive patients with advanced solid tumors,there is no significant difference in the efficacy of vidicetuzumab for injection alone,regardless of prior anti-HER2 therapy.In patients with HER2 over/under expression,the efficacy of vedicizumab for injection alone is comparable;vedicizumab for injection is safe for use in advanced solid tumors with HER2 expression.

关 键 词：实体肿瘤 抗体偶联药物 有效性 不良反应 

分 类 号：R979.1[医药卫生—药品]