[1]陈明镜,杨峤,许子寒,等.基于iRECIST标准的晚期NSCLC免疫治疗的真实世界研究[J].第三军医大学学报,2020,42(05):480-486.
 CHEN Mingjing,YANG Qiao,XU Zihan,et al.Real-world research of advanced NSCLC immunotherapy based on iRECIST criteria[J].J Third Mil Med Univ,2020,42(05):480-486.
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基于iRECIST标准的晚期NSCLC免疫治疗的真实世界研究(/HTML )
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《第三军医大学学报》[ISSN:1000-5404/CN:51-1095/R]

卷:
42卷
期数:
2020年第05期
页码:
480-486
栏目:
临床医学
出版日期:
2020-03-15

文章信息/Info

Title:
Real-world research of advanced NSCLC immunotherapy based on iRECIST criteria
作者:
陈明镜杨峤许子寒李奉杨光荣游启爱余永新孙建国
陆军军医大学(第三军医大学)第二附属医院全军肿瘤研究所 
Author(s):
CHEN Mingjing YANG Qiao XU Zihan LI Feng YANG Guangrong YOU Qi’ai YU Yongxin SUN Jianguo

Cancer Institute of PLA, Second Affiliated Hospital, Army Medical University (Third Military Medical University), Chongqing, 400037, China

关键词:
非小细胞肺癌免疫检查点抑制剂最佳应答无进展生存期免疫相关不良反应
Keywords:
non-small cell lung cancer immune checkpoint inhibitors best overall response progression-free survival immune-related adverse events
分类号:
R181.32; R730.51; R734.2
文献标志码:
A
摘要:

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。

Abstract:

ObjectiveTo 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). MethodsAccording 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. ResultsA 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%). ConclusionOur 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.

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更新日期/Last Update: 2020-03-06