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

您当前的位置：

首页 >

文章列表页 >

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

Clinical Medicine | 更新时间：2026-01-09

- Real-world research of advanced NSCLC immunotherapy based on iRECIST criteria
- Journal of Third Military Medical University Vol. 42, Issue 5, Pages: 480-486(2020)
- 作者机构：
  
  400037 重庆，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
- 作者简介：
- 基金信息：
  
  the General Program of National Natural Science Foundation of China(81972858);the National Natural Science Foundation for Young Scholars of China(81602688);the Cultivation Program for Clinical Research Talents of Army Medical University in 2018(2018XLC1010);and the Natual Science Foundation of Chongqing(CSTS2016jcyjA0531)
- DOI：10.16016/j.1000-5404.201910122
  CLC： R181.32;R730.51;R734.2
- Received：19 October 2019，
  
  Revised：2019-12-26，
  
  Published：15 March 2020
- 稿件说明：
移动端阅览
Mingjing CHEN, Qiao YANG, Zihan XU, et al. Real-world research of advanced NSCLC immunotherapy based on iRECIST criteria[J]. Journal of Third Military Medical University, 2020, 42(5): 480-486.
DOI：

Mingjing CHEN, Qiao YANG, Zihan XU, et al. Real-world research of advanced NSCLC immunotherapy based on iRECIST criteria[J]. Journal of Third Military Medical University, 2020, 42(5): 480-486. DOI： 10.16016/j.1000-5404.201910122.

摘要

目的

2

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

2

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

2

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

2

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

Objective

2

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

2

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

2

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

2

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.

关键词

Keywords

references

SIEGEL R L, MILLER K D, JEMAL A. Cancer statistics, 2019[J]. CA Cancer J Clin, 2019, 69(1): 7-34. DOI:10.3322/caac.21551.

郑荣寿, 孙可欣, 张思维, 等. 2015年中国恶性肿瘤流行情况分析[J].中华肿瘤杂志, 2019, 41(1): 19-28. DOI:10.3760/cma.j.issn.0253-3766.2019.01.005.

ZHENG R S, SUN K X, ZHANG S W, et al . Report of epidemiology in China, 2015[J ] .Chin J Oncol, 2019, 41(1): 19-28. DOI:10.3760/cma.j.issn.0253-3766.2019.01.005.

CHEN Z, FILLMORE C M, HAMMERMAN P S, et al . Non-small-cell lung cancers: a heterogeneous set of diseases[J ] . Nat Rev Cancer, 2014, 14(8): 535-546. DOI:10.1038/nrc3775.

[NOONE AM, HOWLADER N, KRAPCHO M, et al . SEER Cancer Statistics Review, 1975-2015[EB/OL ] . Bethesda, MD: National Cancer Institute.[2018-04-30 ] . https://seer.cancer.gov/csr/1975_2015/ https://seer.cancer.gov/csr/1975_2015/ ..

BUCHBINDER E I, DESAI A. CTLA-4 and PD-1 pathways: similarities, differences, and implications of their inhibition[J]. Am J Clin Oncol, 2016, 39(1): 98-106. DOI:10.1097/COC.0000000000000239.

BRAHMER J, RECKAMP K L, BAAS P, et al . Nivolumab versus docetaxel in advanced squamous-cell non-small-cell lung cancer[J ] . N Engl J Med, 2015, 373(2): 123-135. DOI:10.1056/NEJMoa1504627.

BORGHAEI H, PAZ-ARES L, HORN L, et al . Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer[J ] . N Engl J Med, 2015, 373(17): 1627-1639. DOI:10.1056/NEJMoa1507643.

RECK M, RODRÍGUEZ-ABREU D, ROBINSON A G, et al . Pembrolizumab versus chemotherapy for PD-L1-positive non-small-cell lung cancer[J ] . N Engl J Med, 2016, 375(19): 1823-1833. DOI:10.1056/NEJMoa1606774.

MOK T S K, WU Y L, KUDABA I, et al . Pembrolizumab versus chemotherapy for previously untreated, PD-L1-expressing, locally advanced or metastatic non-small-cell lung cancer(KEYNOTE-042): a randomised, open-label, controlled, phase 3 trial[J ] . Lancet, 2019, 393(10183): 1819-1830. DOI:10.1016/S01 40-6736(18)32409-7.

SHARMA P, HU-LIESKOVAN S, WARGO J A, et al . Primary, adaptive, and acquired resistance to cancer immunotherapy[J ] . Cell, 2017, 168(4): 707-723. DOI:10.1016/j.cell.2017.01.017.

GANDHI L, RODRÍGUEZ-ABREU D, GADGEEL S, et al . Pembrolizumab plus chemotherapy in metastatic non-small-cell lung cancer[J ] . N Engl J Med, 2018, 378(22): 2078-2092. DOI:10.1056/NEJMoa1801005.

SOCINSKIM A, JOTTE R M, CAPPUZZO F, et al . Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC[J ] . N Engl J Med, 2018, 378(24): 2288-2301. DOI:10.1056/nejmoa1716948.

SHERMAN R E, ANDERSON S A, DAL PAN G J, et al . Real-world evidence—what is it and what can it tell us?[J ] . N Engl J Med, 2016, 375(23): 2293-2297. DOI:10.1056/NEJMsb1609216.

FERTÉ C, MARABELLE A. iRECIST: A clarification of tumour response assessment in the immunotherapy era[J]. Eur J Cancer, 2017, 77: 165-167. DOI:10.1016/j.ejca.2017.02.015.

CARBONE D P, RECK M, PAZ-ARES L, et al . First-line nivolumab in stage Ⅳ or recurrent non-small-cell lung cancer[J ] . N Engl J Med, 2017, 376(25): 2415-2426. DOI:10.1056/NEJMoa1613493.

WEST H, MCCLEOD M, HUSSEIN M, et al . Atezolizumab in combination with carboplatin plus nab-paclitaxel chemotherapy compared with chemotherapy alone as first-line treatment for metastatic non-squamous non-small-cell lung cancer(IMpower130): a multicentre, randomised, open-label, phase 3 trial[J ] . Lancet Oncol, 2019, 20(7): 924-937. DOI:10.1016/S1470-2045(19)30167-6.

HERBST R S, BAAS P, KIM D W, et al . Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer(KEYNOTE-010): a randomised controlled trial[J ] . Lancet, 2016, 387(10027): 1540-1550. DOI:10.1016/S0140-6736(15)01281-7.

MURPHY W J, LONGO D L. The surprisingly positive association between obesity and cancer immunotherapy efficacy[J]. JAMA, 2019, 321(13): 1247-1248. DOI:10.1001/jama.2019.0463.

ROUTY B, LE CHATELIER E, DEROSA L, et al . Gut microbiome influences efficacy of PD-1-based immunotherapy against epithelial tumors[J ] . Science, 2018, 359(6371): 91-97. DOI:10.1126/science.aan3706.

GOPALAKRISHNAN V, SPENCER C N, NEZI L, et al . Gut microbiome modulates response to anti-PD-1 immunotherapy in melanoma patients[J ] . Science, 2018, 359(6371): 97-103. DOI:10.1126/science.aan4236.

GETTINGER S, HORN L, JACKMAN D, et al . Five-year follow-up of nivolumab in previously treated advanced non-small-cell lung cancer: results from the CA209-003 study[J ] . J Clin Oncol, 2018, 36(17): 1675-1684. DOI:10.1200/JCO.2017.77.0412.

VOKES E E, READY N, FELIP E, et al . Nivolumab versus docetaxel in previously treated advanced non-small-cell lung cancer(CheckMate 017 and CheckMate 057): 3-year update and outcomes in patients with liver metastases[J ] . Ann Oncol, 2018, 29(4): 959-965. DOI:10.1093/annonc/mdy041.

FEHRENBACHER L, SPIRA A, BALLINGER M, et al . Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer(POPLAR): a multicentre, open-label, phase 2 randomised controlled trial[J ] . Lancet, 2016, 387(10030): 1837-1846. DOI:10.1016/S0140-6736(16)00587-0.

RITTMEYER A, BARLESI F, WATERKAMP D, et al . Atezolizumab versus doc etaxel in patients with previously treated non-small-cell lung cancer(OAK): a phase 3, open-label, multicentre randomised controlled trial[J ] . Lancet, 2017, 389(10066): 255-265. DOI:10.1016/S0140-6736(16)32517-X.

0

Views

0

下载量

0

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Related Articles

Effects of anti-drug antibody on clinical efficacy and adverse reactions of immunotherapy for non-small cell lung cancer

Effect of chronic obstructive pulmonary disease on immunotherapy in patients with advanced non-small cell lung cancer

Risk factors for deep venous thrombosis in patients with advanced lung cancer after treatment of immune checkpoint inhibitors

Integrative model combining deep learning, clinical and radiomic features enhances EGFR mutation prediction in non-small cell lung cancer

Preparation of doxorubicin-loaded polyphyllin H liposomes and synergistic anti-tumor activity against non-small cell lung cancer in vitro

Related Author

赵先兰

李吉茜

杨峤

李世勋

余永新

李奉

李梦侠

孙建国

Related Institution

Department of Diagnostic Radiology， Eastern Theatre General Hospital

Department of Radiology， Daping Hospital， Army Medical University

Department of Radiology，First Affiliated Hospital， Army Medical University （Third Military Medical University）

Infervision Medical Technology Co.， Ltd

Department of Medical Service,No. Hospital of Joint Logistics Support Force

⁰