临床结果超过1L EGFR-TKI进展在mNSCLC中：LUNGFUL实际研究的最终结果。
Clinical Outcomes Beyond 1L EGFR-TKI Progression in mNSCLC: Final Results of the Real-World Study 'LUNGFUL'.
发表日期：2023 May
作者：
Giannis Mountzios, Anna Koumarianou, Helena Linardou, Anastasios Boutis, Dimitrios Mavroudis, Epaminondas Samantas, Ippokratis Korantzis, Elias Athanasiadis, Evangelos G Fergadis, Sofia Lampaki, Vassilis Georgoulias, Sofia Baka, Michalis V Karamouzis, Ioannis Boukovinas, Charalampos Andreadis, Aggeliki Rapti, Nikolaos Koulouris, George Pentheroudakis, Marios E Froudarakis, Alvertos Somarakis, Eleftheria Anastasopoulou, Alexandra Karadimou, Foteini Papageorgiou, Zoe Paparepa, Aristeidis Nikolaou, Christina Papista, Konstantinos N Syrigos
来源：
MOLECULAR & CELLULAR PROTEOMICS
摘要：
需要有关晚期非小细胞肺癌（NSCLC）患者一线/二线EGFR-TKI治疗后进展时EGFR突变谱的实际数据以及治疗策略。该观察性研究在希腊的23家医院肺癌中心进行（协议代码：D133FR00126）。96名符合条件的患者在2017年7月至2019年9月期间连续入组。在79名一线（1L）治疗进展中经过T790M阴性的液态活检测试的患者中，有18名进行了再次活检。在研究人群中，21.9%检测出T790M阳性，而72.9%继续进行二线（2L）治疗，主要包括第三代EGFR-TKI（48.6%）、化疗转换（30.0%）或化疗免疫治疗（17.1%）。二线治疗中T790M阴性患者的客观缓解率（ORR）为27.9％，而T790M阳性患者为50.0％。在可评估的患者中，67.2％的人出现疾病进展；T790M阴性和阳性患者的中位无进展生存期（PFS）分别为5.7和10.0个月。在T790M阴性患者中，接受第三代EGFR-TKI治疗的中位PFS和进展后生存期较长。突变状态和治疗策略被确定为希腊实际情况下EGFR突变NSCLC患者2L情况下临床结果的关键决定因素，早期诊断，适当的分子检测和高效治疗在一线情况下对ORR和PFS产生积极影响。版权所有©2023年国际抗癌研究学会（George J. Delinasios博士），保留所有权利。
Real-world data on the EGFR mutational profile upon progression after first/second-generation EGFR-TKI treatment in patients with advanced non-small-cell lung cancer (NSCLC) and treatment strategies employed thereon are needed.This observational study was conducted in 23 hospital-based lung cancer Centers in Greece (protocol code: D133FR00126). Ninety-six eligible patients were consecutively enrolled between July-2017 and September-2019. Re-biopsy was performed in 18 of 79 patients who tested T790M-negative in liquid biopsy after progression in the first-line (1L) setting.Of the study population, 21.9% tested T790M-positive, while 72.9% proceeded to 2L treatment, mainly comprising of a third-generation EGFR-TKI (48.6%), a switch to chemotherapy (30.0%), or chemo-immunotherapy (17.1%). The objective response rate (ORR) in 2L was 27.9% in T790M-negative and 50.0% in T790M-positive patients. Of evaluable patients, 67.2% experienced disease progression; median progression-free survival (PFS) was 5.7 and 10.0 months among T790M-negative and positive patients, respectively. Among T790M-negative patients, longer median PFS and post-progression survival were observed with third-generation EGFR-TKI treatment.Mutational status and treatment strategy were identified as critical determinants of clinical outcomes in the 2L-setting of EGFR-mutated NSCLC patients in real-world settings in Greece, with early diagnosis, appropriate molecular testing and high-efficacy treatments at first lines positively affecting ORR and PFS.Copyright © 2023 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.