Feasibility and clinical impact of re-biopsy in advanced non small-cell lung cancer: A prospective multicenter study in a real-world setting (GFPC study 12-01)
Feasibility and clinical impact of re-biopsy in advanced non small-cell lung cancer: A prospective multicenter study in a real-world setting (GFPC study 12-01)
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DOI：
10.1016/j.lungcan.2014.08.016
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发表时间：
2014-11-01
期刊：
影响因子：
5.3
通讯作者：
Vergnenegre, Alain
中科院分区：
文献类型：
--
作者：
Chouaid, Christos;Dujon, Cecile;Vergnenegre, Alain
目的：当晚期非小细胞肺癌（NSCLC）在一线治疗期间进展时，可能需要再次活检以检测可能的新生物学特征（与初始状态比较、出现耐药生物标志物或评估新生物标志物）。这一务实的前瞻性多中心研究的目的是评估的可行性和临床实用性，在晚期NSCLC的再活检在现实世界setting.Methods：主要纳入标准是晚期NSCLC的适应症，由患者的临床医生确定的重复活检。主要结局是成功手术的百分比。次要结局是手术类型、新的生物学状态、手术耐受性和临床效用结果：从2012年5月至2013年5月，18个中心招募了100名患者（男性：44%;中位年龄：64.8岁; PS 0/1：88%;腺癌：89%; EGFR突变：50%;无初始生物学特征：16.4%）。19.5%的病例无法再次活检，25.6%的病例没有提供或提供太少的肿瘤细胞。30.4%（25/82）的病例重复活检对指导治疗有帮助。并发症很少（2例中度出血和1例气胸）。结论：在现实世界中，晚期NSCLC再次活检是可行的，不良事件是可以接受的。需要对再次活检的适应症、程序的选择、取样部位和实验室分析制定指南。(C)2014爱思唯尔爱尔兰有限公司版权所有。
Objectives: When advanced non-small-cell lung cancer (NSCLC) progresses during first-line treatment, re-biopsy may be indicated to detect a possible new biological profile (comparison to initial status, emergence of resistance biomarkers, or assessment of new biomarkers). The aim of this pragmatic prospective multicenter study was to assess the feasibility and clinical utility of re-biopsy in advanced NSCLC in a real-world setting.Methods: The main inclusion criteria were advanced NSCLC with an indication for repeat biopsy identified by the patient's clinician. The primary outcome was the percentage of successful procedures. Secondary outcomes were the type of procedure, new biological status, tolerability of the procedure, and clinical utility (treatment modification).Results: From May 2012 to May 2013, 18 centers enrolled 100 patients (males: 44%; median age: 64.8 years; PS 0/1: 88%; adenocarcinoma: 89%; EGFR mutated: 50%; no initial biological profile: 16.4%). Re-biopsy was not possible in 19.5% of cases and provided no or too few tumor cells in 25.6% of cases. Repeat biopsy was useful for guiding treatment in 30.4% (25/82) of cases. Complications were infrequent (2 cases of moderate bleeding and 1 case of pneumothorax).Conclusion: Re-biopsy of advanced NSCLC is feasible in the real-world setting, with acceptable adverse events. Guidelines are needed on the indications of re-biopsy, the choice of procedure, the sampling site, and laboratory analysis. (C) 2014 Elsevier Ireland Ltd. All rights reserved.