基于iRECIST标准的晚期NSCLC免疫治疗的真实世界研究

Real-world research of advanced NSCLC immunotherapy based on iRECIST criteria

目的根据iRECIST标准(modified RECIST1.1 for immune based therapeutics),评估免疫检查点抑制剂(immune checkpoint inhibitors,ICIs)治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)的真实世界数据。方法按真实世界研究方法,纳入本院2016年8月10日至2019年7月10日接受免疫检查点抑制剂治疗的晚期NSCLC患者,按iRECIST标准评估一线单药、一线联合、二线单药、二线联合的临床疗效,包括最佳应答(best overall response,bOR)、无进展生存时间(progression-free survival,PFS)、缓解持续时间(duration of response,DoR)等,并评价免疫相关不良反应(immue-related adverse events,irAEs)。结果共纳入61例Ⅳ期NSCLC患者,其中男性54例,女性7例;中位年龄58岁;腺癌31例,鳞癌30例。一线单药bOR为27.3%,中位PFS(mPFS)为11.8个月;一线联合bOR为47.1%,mPFS未达到;一线总体bOR为35.9%,mPFS为11.8个月;二线单药bOR为30%,mPFS为6.0个月;二线联合bOR为41.7%,mPFS未达到;二线总体bOR为36.4%,mPFS为6.3个月。最常见的irAEs为1~2级皮肤毒性(5例,8.20%)。结论基于iRECIST标准评估免疫检测点抑制剂治疗晚期NSCLC的真实世界研究显示,一线单药、一线联合及二线单药bOR及PFS获益优于既往RCT研究结果,而二线联合的bOR及PFS显著优于单药治疗,irAEs可控。

Objective To analyze the real-world data about immune checkpoint inhibitors(ICIs)for advanced non-small cell lung cancer(NSCLC)based on the modified RECIST 1.1 for immune based therapeutics(iRECIST).Methods According to real-world research methods,all advanced NSCLC patients treated with immune checkpoint inhibitors(ICIs)in our hospital from August 10,2016 to July 10,2019 were enrolled in this study.The efficacy,including best overall response(bOR),progression-free survival(PFS)and duration of response(DoR)was evaluated in first-line monotherapy,first-line combination,second-line monotherapy and second-line combination based on iRECIST.Also,immune-related adverse events(irAEs)were evaluated.Results A total of 61 patients(54 males and 7 females)with stage IV NSCLC were included,at a median age of 58 years,and there were 31 cases of adenocarcinoma and 30 cases of squamous carcinoma.The bOR and mPFS were 27.3%and 11.8 months,respectively,for first-line monotherapy;47.1%and not reached(NR),respectively,for first-line combination,and 35.9%and 11.8 months,respectively,for first-line totally.And the bOR and mPFS were 30%and 6.0 months,respectively,for the second-line monotherapy;were 41.7%and NR,respectively,for second-line combination;and were 36.4%and 6.3 months,respectively for second-line totally.The most common irAEs was grade 1~2 skin toxicity(5 cases,8.2%).Conclusion Our results show that bOR and PFS of first-line monotherapy,first-line combination,second-line monotherapy are better than the results of previous RCT,and bOR and PFS of second-line combination are significantly better than second-line monotherapy.irAEs are controllable study.