PD-1抑制剂对非小细胞肺癌的近期疗效与安全性观察

Short-term efficacy and safety of PD-1 inhibitor in the treatment of non-small cell lung cancer

目的分析程序性死亡受体-1(PD-1)抑制剂在非小细胞肺癌(NSCLC)中的疗效及安全性。方法回顾性收集2020-01-01-2021-06-30在嘉兴市第一医院接受PD-1抑制剂治疗的NSCLC患者149例,对用药信息、免疫治疗相关不良反应(irAEs)、客观缓解率(ORR)和疾病控制率(DCR)进行分析,采用χ^(2)检验比较组间差异,二分类logistic回归分析与irAEs发生有关的独立危险因素。结果6种PD-1抑制剂中信迪利单抗占比最高(48例,32.2%);联合化疗是最主要的治疗方式(86例,57.7%)。irAEs发生率为47.7%(71/149),其中≥3级的irAEs发生率为6.7%(10/149),且单药治疗高于联合治疗(14.3%vs 3.7%),χ^(2)=5.359,P=0.021;二分类logistic回归分析结果显示,吸烟史是发生irAEs的独立危险因素,OR=2.521,95%CI:1.235~5.146,P=0.011。总人群的ORR为23.5%,DCR为83.2%,其中PD-L1肿瘤细胞阳性比例分数(TPS)≥1%较PD-L1TPS<1%者具有较高的DCR(90.3%vs 66.7%),χ^(2)=4.814,P=0.028;一线治疗的DCR高于后线治疗(90.4%vs 74.2%),χ^(2)=6.841,P=0.009;irAEs组较无irAEs组有较高的ORR(33.8%vs 14.1%,χ^(2)=8.026,P=0.005)和DCR(93.0%vs 74.4%,χ^(2)=9.208,P=0.002)。结论PD-1抑制剂治疗晚期NSCLC疗效尚可,irAEs发生率与疗效相关。

Objective To study the short-term efficacy and safety of anti-programmed cell death-1(PD-1)drugs in non-small cell lung cancer(NSCLC)in real world.Methods Totally 149 patients with NSCLC treated with anti-PD-1 drugs in the First Hospital of Jiaxing from January 1,2020 to June 30,2021 were collected,and analyzed drug information,immune related adverse reactions(irAEs),objective response rate(ORR)and disease control rate(DCR).χ^(2)test was used for comparison between groups,logistic regression multivariate analysis was used to analyze the independent risk factors associated with irAEs.Results Sintilimab accounted for the highest proportion(48 cases,32.2%)among the six anti-PD-1 drugs;combined chemotherapy was the main treatment of immunotherapy(86 cases,57.7%).The incidence of irAEs was 47.7%(71/149),and the incidence of irAEs exceeding grade 3 was 6.7%(10/149).The incidence of irAEs exceeding grade 3 using anti-PD-1 drugs monotherapy was more than that in combination therapy(14.3%vs 3.7%,χ^(2)=5.359,P=0.021).Logistic regression multivariate analysis showed that smoking history was independent risk factor for irAEs(OR=2.521,95%CI:1.235-5.146,P=0.011).Among the overall population,the ORR was 23.5%,the DCR was 83.2%.PD-L1 tumor proportion score(TPS)≥1%had higher DCR than PD-L1 TPS<1%(90.3%vs 66.7%,χ^(2)=4.814,P=0.028).The first line treatment had higher DCR than the posterior line treatment(90.4%vs 74.2%,χ^(2)=6.841,P=0.009).The irAEs group had higher ORR(33.8%vs 14.1%,χ^(2)=8.026,P=0.005)and DCR(93.0%vs 74.4%,χ^(2)=9.208,P=0.002)than non-irAEs group.Conclusion Anti-PD-1 drugs have good curative effect in the treatment of advanced NSCLC,and the incidence of irAEs is related to the curative effect.