程序性死亡受体1抑制剂一线治疗晚期非小细胞肺癌的预后及安全性  

Prognosis and Safety of Programmed Death 1 Inhibitors in First-Line Treatment of Advanced Non-Small Cell Lung Cancer

作　　者：左刚[1] 王根和[1] 方平[1] ZUO Gang;WANG Genhe;FANG Ping(Dept.of Oncology,Huangshan People’s Hospital,Anhui Huangshan 245000,China)

机构地区：[1]黄山市人民医院肿瘤内科,安徽黄山245000

出　　处：《中国医院用药评价与分析》2022年第11期1340-1344,1348,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：吴阶平医学基金会临床科研专项资助基金项目(No.320.6750.2020-01-22)。

摘　　要：目的:探讨程序性死亡受体1(PD-1)抑制剂作为一线治疗晚期非小细胞肺癌(NSCLC)方案的预后及安全性。方法:收集2019年5月至2021年1月该院采用3种PD-1抑制剂(卡瑞利珠单抗、信迪利单抗和替雷利珠单抗)作为一线治疗的90例晚期NSCLC患者的临床资料,回顾性分析患者的临床特征和不良反应,比较临床特征对PD-1抑制剂一线治疗晚期NSCLC的疾病控制率(DCR)、无进展生存期(PFS)的影响。结果:所有患者的客观缓解率为54.4%(49/90),DCR为78.9%(71/90),多因素分析结果显示,Ⅲb和Ⅲc期、联合化疗及PD-1阳性为影响晚期NSCLC的DCR保护因素(P<0.05)。随访观察中,90例患者的中位PFS为8.6个月;COX回归结果显示,Ⅲb和Ⅲc期、联合化疗及PD-1阳性是晚期NSCLC的PFS保护因素,Ⅲb和Ⅲc期(中位PFS:11.0个月vs.7.2个月,χ^(2)=4.152,P=0.042)、联合化疗(中位PFS:9.6个月vs.7.6个月,χ^(2)=4.066,P=0.044)及PD-1阳性(中位PFS:10.9个月vs.6.6个月,χ^(2)=13.978,P<0.001)患者有较长的PFS。患者总不良反应发生率为67.8%(61/90),使用卡瑞利珠单抗、信迪利单抗和替雷利珠单抗患者的不良反应发生率分别为75.0%(21/28)、73.3%(22/30)和56.3%(18/32),组间差异无统计学意义(χ^(2)=3.041,P=0.218)。结论:PD-1抑制剂作为一线治疗方案治疗晚期NSCLC患者具有较好的临床价值,但应注意治疗过程中的不良反应。Ⅲb和Ⅲc期、PD-L1阳性的晚期NSCLC患者使用PD-1抑制剂的临床效果较好,同时采用PD-1联合化疗患者收益更佳。OBJECTIVE:To probe into the prognosis and safety of programmed death 1(PD-1)inhibitors in first-line treatment of advanced non-small cell lung cancer(NSCLC).METHODS:Clinical data of 90 patients with advanced NSCLC treated with three kinds of PD-1 inhibitors(camrelizumab,sintilizumab and tislelizumab)as first-line treatment in the hospital from May 2019 to Jan.2021 were collected.Clinical characteristics and adverse drug reactions were retrospectively analyzed,and the effects of clinical characteristics on disease control(DCR)and progression-free survival(PFS)of advanced NSCLC treated with PD-1 inhibitors as first-line treatment were compared.RESULTS:The objective response rate(ORR)of all patients was 54.4%(49/90),and the DCR was 78.9%(71/90).Multivariate analysis showed thatⅢb andⅢc,combined chemotherapy and PD-1 positive were the protective factors for DCR in advanced NSCLC(P<0.05).In follow-up observation,the median PFS of 90 patients was 8.6 months.COX regression analysis showed that sⅢb andⅢc,combined chemotherapy and PD-1 positive were the protective factors of PFS in advanced NSCLC.Ⅲb andⅢc(median PFS:11.0 months vs.7.2 months,χ^(2)=4.152,P=0.042),combined chemotherapy(median PFS:9.6 months vs.7.6 months,χ^(2)=4.066,P=0.044)and PD-1 positive(median PFS:10.9 months vs.6.6 months,χ^(2)=13.978,P<0.001)patients had longer PFS.The overall incidence of adverse drug reactions was 67.8%(61/90).The incidences of adverse drug reactions of camrelizumab,sintilide and tislelizumab were respectively 75.0%(21/28),73.3%(22/30)and 56.3%(18/32),there was no significant difference among three groups(χ^(2)=3.041,P=0.218).CONCLUSIONS:PD-1 inhibitors have good clinical value as the first-line treatment for patients with advanced NSCLC,yet attention should be paid to adverse drug reactions during treatment.The clinical effect of PD-1 inhibitor is better for advanced NSCLC patients withⅢb andⅢc,and PD-L1 positive,and patients treated with PD-1 combined with chemotherapy have better benefits.

关 键 词：非小细胞肺癌 程序性死亡受体1 预后 疗效 

分 类 号：R979.1[医药卫生—药品]