PD-1/PD-L1抑制剂治疗老年晚期非小细胞肺癌患者的疗效及安全性研究

Efficacy and Safety of PD-1/PD-L1 Inhibitors in the Treatment of Elderly Patients with Advanced Non-Small Cell Lung Cancer

目的:探讨真实世界中程序性死亡蛋白1(PD-1)/程序性死亡蛋白配体1(PD-L1)抑制剂在<65岁或≥65岁的晚期非小细胞癌患者一线、二线及以上治疗中的疗效及安全性。方法:回顾性选取2017年5月至2021年5月于该院就诊的使用PD-1/PD-L1抑制剂治疗的局部晚期或转移性非小细胞肺癌(NSCLC)患者274例为研究对象,分为年龄<65岁组(130例)及≥65岁组(144例),观察随访,末次随访时间为2021年10月5日。比较<65岁组及≥65岁组患者在一线、二线及以上治疗中的无进展生存期(PFS)、总生存期(OS)及不良反应发生率。结果:一线治疗中,<65岁组患者的中位PFS显著长于≥65岁组,差异有统计学意义(9个月vs.5个月,95%CI=0.2396~0.7617,P=0.0039);而两组患者OS的差异无统计学意义(12个月vs.7个月,95%CI=0.3478~1.1380,P=0.1254)。二线治疗中,两组患者PFS(5个月vs.4个月,95%CI=0.5497~1.1950,P=0.2893)、OS(8个月vs.8个月,95%CI=0.7449~1.6050,P=0.6480)的差异均无统计学意义。在安全性方面,<65岁组患者间质性肺炎的发病率高于≥65岁组,差异有统计学意义[12.31%(16/130)vs.5.56%(8/144),P=0.0483]。结论:老年晚期NSCLC患者使用PD-1/PD-L1抑制剂在一线治疗中疗效低于成年患者,而二线治疗中与成年患者的差异无统计学意义;老年晚期NSCLC患者使用PD-1/PD-L1抑制剂的耐受性较好,且间质性肺炎发生率低于成年患者,但本研究结果仍需大样本量研究结果证实。

OBJECTIVE:To explore the real-world efficacy and safety of programmed death protein 1(PD-1)/programmed death protein ligand 1(PD-L1)inhibitor in first-line,second-line and above treatment of<65 years old and≥65 years old patients with advanced non-small cell cancer.METHODS:A total of 274 patients with locally advanced or metastatic non-small cell lung cancer(NSCLC)treated with PD-1/PD-L1 inhibitors in the hospital from May 2017 to May 2021 were retrospectively extracted as the study subjects,and were divided into<65 years old group(130 cases)and≥65 years old group(144 cases).The last follow-up was Oct.5th,2021.The progression free survival(PFS),overall survival(OS)and adverse drug reactions were compared between<65 years old group and≥65 years old group in first-line,second-line and above treatment.RESULTS:In first-line treatment,the median PFS in<65 years old group was significantly higher than that in≥65 years old group,with statistically significant difference(9 months vs.5 months,95%CI=0.2396-0.7617,P=0.0039);there was no significant difference in OS between two groups(12 months vs.7 months,95%CI=0.3478-1.1380,P=0.1254).In second-line treatment,there were no significant differences in PFS(5 months vs.4 months,95%CI=0.5497-1.1950,P=0.2893)and OS(8 months vs.8 months,95%CI=0.7449-1.6050,P=0.6480)between two groups.In terms of safety,the incidence of interstitial pneumonia in<65 years old group was higher than that in≥65 years old group,the difference was statistically significant[12.31%(16/130)vs.5.56%(8/144),P=0.0483].CONCLUSIONS:The efficacy of elderly patients with advanced NSCLC treated with PD-1/PD-L1 inhibitors in first-line treatment is lower than that of adult patients,while the difference is not statistically significant in second-line treatment.Elderly patients with advanced NSCLC have better tolerance to PD-1/PD-L1 inhibitors,and the incidence of interstitial pneumonia is lower than that of adults.However,the results of this study still need to be confirmed by large sample size study.