信迪利单抗注射液联合注射用紫杉醇(白蛋白结合型)治疗复发或难治性ES-SCLC的临床研究  

Clinical Research on Sintilimab Injection Combined with Paclitaxel Injection (Albumin-Bound) in the Treatment of Relapsed or Refractory ES-SCLC

作　　者：李卉惠[1] 李广欣 赵鹏飞[1] 林海珊[1] 赵磊[1] 俞静[1] 张颖[1] LI Huihui;LI Guangxin;ZHAO Pengfei;LIN Haishan;ZHAO Lei;YU Jing;ZHANG Ying(Cancer Center,Beijing Friendship Hospital,Capital Medical University,Beijing 100050,China;Dept.of Radiation Therapy,Tsinghua Changgung Hospital Affiliated to Tsinghua University,Beijing 102218,China)

机构地区：[1]首都医科大学附属北京友谊医院肿瘤中心,北京100050 [2]清华大学附属北京清华长庚医院放射治疗科,北京102218

出　　处：《中国医院用药评价与分析》2024年第8期901-904,909,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家自然科学基金资助项目(No.81774221)。

摘　　要：目的:评估信迪利单抗注射液联合注射用紫杉醇(白蛋白结合型)在复发或难治性广泛期(ES)小细胞肺癌(SCLC)患者二线治疗中的疗效和安全性。方法:选择2022年1月至2023年1月首都医科大学附属北京友谊医院收治的一线应用依托泊苷/铂类药物化疗后进展的ES-SCLC患者74例,根据随机数字表法分为研究组38例和对照组36例。研究组患者给予信迪利单抗注射液联合注射用紫杉醇(白蛋白结合型)治疗,对照组患者给予注射用盐酸托泊替康治疗。观察两组患者的客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS)及不良反应。结果:研究组、对照组患者的ORR分别为26.3%(10/38)、13.9%(5/36)(P=0.035),DCR分别为84.2%(32/38)、72.2%(26/36)(P=0.042),中位PFS分别为6.00、3.45个月(P=0.013),中位OS分别为10.30、8.75个月(P=0.007),上述差异均有统计学意义。两组患者不良反应发生率的差异无统计学意义(P>0.05)。结论:与注射用盐酸托泊替康相比,信迪利单抗注射液联合紫杉醇(白蛋白结合型)延长了复发或难治性ES-SCLC患者的生存期,且不良反应可耐受。OBJECTIVE:To evaluate the efficacy and safety of sintilimab injection combined with paclitaxel injection(albumin-bound)in the second-line treatment of patients with relapsed or refractory extensive stage(ES)of small cell lung cancer(SCLC).METHODS:A total of 74 patients with ES-SCLC who progressed after first-line application of etoposide/platinum-based chemotherapy admitted into Beijing Friendship Hospital,Capital Medical University from Jan.2022 to Jan.2023 were selected to be divided into 38 cases in the research group and 36 cases in the control group via random number table method.The research group was given sintilimab injection combined with paclitaxel injection(albumin-bound),while the control group received topotecan hydrochloride injection.The objective remission rate(ORR),disease control rate(DCR),progression-free survival(PFS),overall survival(OS)and adverse drug reactions of both groups were observed.RESULTS:The ORR of research group and control group were 26.3%(10/38)and 13.9%(5/36)(P=0.035),the DCR were 84.2%(32/38)and 72.2%(26/36)(P=0.042),the median PFS were 6.00 months and 3.45 months(P=0.013),the median OS were 10.30 months and 8.75 months(P=0.007),respectively,with statistically significant differences.There was no statistically significant difference in the incidences of adverse drug reactions between two groups(P>0.05).CONCLUSIONS:Compared with the topotecan hydrochloride injection,sindilizumab injection in combination with paclitaxel(albumin-bound)has prolonged survivals in patients with relapsed or refractory ES-SCLC with tolerable adverse drug reactions.

关 键 词：信迪利单抗 紫杉醇 安全性 有效性 小细胞肺癌 程序性死亡受体配体1 

分 类 号：R979.1[医药卫生—药品]