程序性死亡蛋白配体-1表达阴性的晚期非鳞非小细胞肺癌患者程序性死亡蛋白-1抑制剂联合化疗与贝伐珠单抗联合化疗的疗效对比及生存分析  

Programmed death-1 inhibitor plus chemotherapy versus bevacizumab plus chemotherapy in first-line treatment for negative programmed death ligand-1 expression non-squamous non-small cell lung carcinoma

作　　者：李亚男[1] 杨文雨 刘哲峰[3] Li Yanan;Yang Wenyu;Liu Zhefeng(Graduate School,Chinese PLA General Hospital/Chinese PLA Medical School,Beijing 100853,China;Department of Clinical Medicine,Nankai University,Tianjin 300071,China;Key Laboratory for Tumor Targeting Therapy and Antibody Drugs,Chinese PLA Key Laboratory of Oncology,Department of Oncology,Chinese PLA General Hospital,the First Medical Center,Beijing 100853,China)

机构地区：[1]解放军总医院研究生院解放军医学院,北京100853 [2]南开大学临床医学系,天津300071 [3]解放军总医院第一医学中心肿瘤内科全军肿瘤学重点实验室肿瘤靶向治疗和抗体药物教育部重点实验室,北京100853

出　　处：《肿瘤综合治疗电子杂志》2022年第2期93-98,共6页Journal of Multidisciplinary Cancer Management(Electronic Version)

摘　　要：目的比较程序性死亡蛋白配体-1(programmed death ligand-1,PD-L1)表达阴性的晚期非鳞非小细胞肺癌(non-small cell lung carcinoma,NSCLC)患者一线治疗使用程序性死亡蛋白-1(programmed death-1,PD-1)抑制剂联合化疗与使用贝伐珠单抗联合化疗的疗效和安全性。方法回顾性分析2015年1月至2021年11月于解放军总医院第一医学中心就诊的PD-L1表达阴性的晚期非鳞NSCLC患者的临床资料。根据一线治疗方案进行分组,方案为PD-1抑制剂联合化疗的23例患者纳入PD-1抑制剂组,方案为贝伐珠单抗联合化疗的42例患者纳入贝伐珠单抗组。每2个周期评估两组患者的疗效和安全性。结果PD-1抑制剂组患者的客观缓解率显著高于贝伐珠单抗组(69.6%∶35.7%,P=0.01)。随访截至2021年11月,PD-1抑制剂组和贝伐珠单抗组患者中位无进展生存(progression-free survival,PFS)时间分别为7.8个月(95%CI:7.3~8.3)、6.5个月(95%CI:4.9~8.1),两组患者PFS时间比较差异无统计学意义(P>0.05),但PD-1抑制剂组患者PFS时间有获益趋势。两组患者不良反应谱相似,但PD-1抑制剂组患者3~4级不良反应发生率显著高于贝伐珠单抗组(P=0.036)。结论在PD-L1表达阴性的晚期非鳞NSCLC患者的一线治疗中,PD-1抑制剂联合化疗的近期疗效优于贝伐珠单抗联合化疗,但3~4级不良反应发生率更高。两种治疗方案的远期生存无统计学意义。Objective To compare the efficacy and safety of first-line treatment with chemotherapy in combination with programmed death-1(PD-1)inhibitors versus bevacizumab in patients with advanced non-small cell lung carcinoma(NSCLC)who are negative for programmed death ligand-1(PD-L1)expression.Method Patients with advanced non-squamous NSCLC with negative PD-L1 expression who received first-line anti-PD-1 plus chemotherapy or bevacizumab plus chemotherapy from January 2017 to November 2021 in the Department of Oncology of the First Medical Center of PLA General Hospital were included in the study.Patients who received anti-PD-1 plus chemotherapy were included in anti-PD-1 group(n=23),and patients received bevacizumab plus chemotherapy were included in bevacizumab group(n=42).The efficacy and safety of the two groups were evaluated every 2 cycles.Result The objective response rates(ORR)in anti-PD-1 was significantly higher than that in bevacizumab group(69.6%vs 35.7%,P=0.01).November 2021 ended,the median progression-free survival(PFS)time of the two groups were 7.8 months(95%CI:7.3~8.3)and 6.5 months(95%CI:4.9~8.1),respectively,with no statistical difference(P>0.05).But anti-PD-1 group had a tendency to benefit in PFS time.The incidence of adverse reactions were similar between the two groups,but the incidence of grade 3 to 4 adverse reactions was significantly higher in PD-1 inhibitor group than that in bevacizumab group(P=0.036).Conclusion In the first-line treatment of patients with advanced non-squamous NSCLC with negative PD-L1 expression,the near-term efficacy of PD-1 inhibitors combined with chemotherapy is superior to that of bevacizumab combined with chemotherapy,but the incidence of grade 3 to 4 adverse reactions is higher.Long-term survival is not statistically significant for the two treatment regimens.

关 键 词：程序性死亡蛋白配体-1 非鳞非小细胞肺癌 程序性死亡蛋白-1抑制剂 贝伐珠单抗 化疗 客观缓解率 无进展生存 不良反应 

分 类 号：R734.2[医药卫生—肿瘤]