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免疫疗法在临床试验中代表性不足的晚期非小细胞肺癌患者中的应用。

Immunotherapy in Patients with Advanced Non-Small-Cell Lung Cancer Under-Represented by Clinical Trials.

机构信息

CancerCare Manitoba, Winnipeg, MB R3E 0V9, Canada.

出版信息

Curr Oncol. 2024 Sep 14;31(9):5498-5515. doi: 10.3390/curroncol31090407.

DOI:10.3390/curroncol31090407
PMID:39330035
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11431477/
Abstract

Since the initial US FDA approval of an immune checkpoint inhibitor (ICI) for the treatment of non-oncogene-driven non-small-cell lung cancer (NSCLC) nine years ago, this therapeutic strategy has been cemented as a crucial component of treatment for most of these patients. However, there is a clear efficacy-effectiveness gap whereby patients in the 'real world' seem to have more modest clinical outcomes compared to those enrolled in landmark clinical trials. This gap may be driven by the under-representation of important patient populations, including populations defined by clinical or molecular characteristics. In this review, we summarize the data outlining the evidence of ICIs in patients with poor Eastern Cooperative Oncology Group performance status (ECOG PS), underlying autoimmune disease (AID), older age, active brain metastases (BMs), and molecular aberrations such as mutations, fusions, mutations and fusions.

摘要

自九年前美国食品药品监督管理局(FDA)首次批准免疫检查点抑制剂(ICI)用于治疗非驱动基因的非小细胞肺癌(NSCLC)以来,这种治疗策略已成为大多数此类患者治疗的重要组成部分。然而,疗效差距明显,与纳入标志性临床试验的患者相比,“真实世界”中的患者的临床结局似乎较为温和。这种差距可能是由于重要患者人群代表性不足所致,包括基于临床或分子特征定义的人群。在这篇综述中,我们总结了有关 ICI 在以下患者中的应用数据:ECOG 表现状态(PS)较差、潜在自身免疫性疾病(AID)、年龄较大、有活动性脑转移(BMs),以及存在突变、融合、缺失和融合等分子异常的患者。

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Immunotherapy in Patients with Advanced Non-Small-Cell Lung Cancer Under-Represented by Clinical Trials.免疫疗法在临床试验中代表性不足的晚期非小细胞肺癌患者中的应用。
Curr Oncol. 2024 Sep 14;31(9):5498-5515. doi: 10.3390/curroncol31090407.
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本文引用的文献

1
Phase III KEYNOTE-789 Study of Pemetrexed and Platinum With or Without Pembrolizumab for Tyrosine Kinase Inhibitor‒Resistant, -Mutant, Metastatic Nonsquamous Non-Small Cell Lung Cancer.帕博利珠单抗联合培美曲塞和铂类对比培美曲塞和铂类用于治疗 EGFR/ALK 抑制剂耐药、突变的转移性非鳞状非小细胞肺癌的 III 期 KEYNOTE-789 研究
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Phase III, Randomized Study of Atezolizumab Plus Bevacizumab and Chemotherapy in Patients With - or -Mutated Non-Small-Cell Lung Cancer (ATTLAS, KCSG-LU19-04).III 期随机研究阿特珠单抗联合贝伐珠单抗和化疗治疗 - 或 - 突变的非小细胞肺癌患者(ATTLAS,KCSG-LU19-04)。
J Clin Oncol. 2024 Apr 10;42(11):1241-1251. doi: 10.1200/JCO.23.01891. Epub 2023 Oct 20.
6
Phase II Trial of Atezolizumab Combined With Carboplatin and Pemetrexed for Patients With Advanced Nonsquamous Non-Small-Cell Lung Cancer With Untreated Brain Metastases (Atezo-Brain, GECP17/05).阿特珠单抗联合卡铂和培美曲塞治疗未经治疗的脑转移的晚期非鳞状非小细胞肺癌患者的 II 期临床试验(Atezo-Brain,GECP17/05)。
J Clin Oncol. 2023 Oct 1;41(28):4478-4485. doi: 10.1200/JCO.22.02561. Epub 2023 Aug 21.
7
First-line atezolizumab monotherapy versus single-agent chemotherapy in patients with non-small-cell lung cancer ineligible for treatment with a platinum-containing regimen (IPSOS): a phase 3, global, multicentre, open-label, randomised controlled study.一线阿特珠单抗单药治疗与含铂方案治疗不适用的非小细胞肺癌患者的单药化疗(IPSOS):一项全球、多中心、开放标签、随机对照的 3 期临床试验。
Lancet. 2023 Aug 5;402(10400):451-463. doi: 10.1016/S0140-6736(23)00774-2. Epub 2023 Jul 6.
8
Real-World Outcomes of Stage IV NSCLC with PD-L1 ≥ 50% Treated with First-Line Pembrolizumab: Uptake of Second-Line Systemic Therapy.一线帕博利珠单抗治疗 PD-L1≥50%的 IV 期 NSCLC 的真实世界结局:二线系统治疗的应用。
Curr Oncol. 2023 May 26;30(6):5299-5308. doi: 10.3390/curroncol30060402.
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Safety and Efficacy of Immune Checkpoint Inhibitors in Cancer Patients and Preexisting Autoimmune Disease: A Systematic Review and Meta-Analysis in Non-Small-Cell Lung Cancer.免疫检查点抑制剂在癌症患者和伴发自身免疫性疾病患者中的安全性和疗效:非小细胞肺癌的系统评价和荟萃分析。
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