PD-1/PD-L1抑制剂治疗晚期驱动基因阴性非小细胞肺癌患者的有效性和安全性

Efficacy and safety of PD-1/PD-L1 inhibitors in the treatment of patients with advanced driver gene-negative non-small cell lung cancer

目的分析程序性死亡受体1/程序性死亡配体1(PD-1/PD-L1)抑制剂治疗晚期(Ⅲ期、Ⅳ期)驱动基因阴性非小细胞肺癌(NSCLC)患者的有效性和安全性。方法选取2019年1月至2021年10月在昆明医科大学第一附属医院就诊的80例晚期驱动基因阴性NSCLC患者为研究对象,根据治疗方案不同将其分为单独化疗组[n=40,采用含铂两药AP方案(培美曲塞+铂)或TP方案(紫杉醇+铂)]和联合治疗组(n=40,在单独化疗组基础上联合PD-1/PD-L1抑制剂)。比较两组的治疗效果。结果联合治疗组的客观缓解率(ORR)、疾病控制率(DCR)高于单独化疗组,差异具有统计学意义(P<0.05)。两组的Ⅰ~Ⅳ级各项不良反应占比无统计学差异(P>0.05)。联合治疗组的中位无进展生存期(PFS)为11个月,长于单独化疗组的6个月,差异具有统计学意义(P<0.05)。结论PD-1/PD-L1抑制剂治疗晚期驱动基因阴性NSCLC患者的效果良好,安全性高,值得临床推广应用。

Objective To analyze the efficacy and safety of programmed cell death protein 1/programmed cell death ligand 1(PD-1/PD-L1)inhibitors in the treatment of advanced(stageⅢ,Ⅳ)driver gene negative non-small cell lung cancer(NSCLC)patients.Methods A total of 80 patients with advanced driver gene-negative NSCLC who were admitted in the First Affiliated Hospital of Kunming Medical University from January 2019 to October 2021 were selected as the research objects.According to different treatment regimens,the patients were divided into single chemotherapy group[n=40,using platinum-containing two-drug AP regimen(pemetrexed+platinum)or TP regimen(paclitaxel+platinum)]and combined treatment group(n=40,combined with PD-1/PD-L1 inhibitor on the basis of single chemotherapy group).The therapeutic effects of the two groups were compared.Results The objective response rate(ORR)and disease control rate(DCR)of the combined treatment group were higher than those of the single chemotherapy group,and the differences were statistically significant(P<0.05).There were no significant differences in the proportion of gradeⅠ-Ⅳadverse reactions between the two groups(P>0.05).The median progression-free survival(PFS)of the combined treatment group was 11 months,which was longer than 6 months of the single chemotherapy group,and the difference was statistically significant(P<0.05).Conclusion PD-1/PD-L1 inhibitors are effective and safe in the treatment of patients with advanced driver gene-negative NSCLC,which is worthy of clinical application and promtion.