Haentschel Maik, Boeckeler Michael, Bonzheim Irina, Schimmele Florian, Spengler Werner, Stanzel Franz, Petermann Christoph, Darwiche Kaid, Hagmeyer Lars, Buettner Reinhard, Tiemann Markus, Schildhaus Hans-Ulrich, Muche Rainer, Boesmueller Hans, Everinghoff Felix, Mueller Robert, Atique Bijoy, Lewis Richard A, Zender Lars, Fend Falko, Hetzel Juergen
Department of Medical Oncology and Pneumology, Eberhard Karls University, 72076 Tübingen, Germany.
Institute of Pathology and Neuropathology, Reference Center for Haematopathology University Hospital, Tuebingen Eberhard-Karls-University, 72076 Tübingen, Germany.
Diagnostics (Basel). 2020 Jul 6;10(7):459. doi: 10.3390/diagnostics10070459.
The detection of molecular alterations is crucial for the individualized treatment of advanced non-small cell lung cancer (NSCLC). Missing targetable alterations may have a major impact on patient's progression free and overall survival. Although laboratory testing for molecular alterations has continued to improve; little is known about how biopsy technique affects the detection rate of different mutations. In the retrospective study detection rate of epidermal growth factor (EGFR) mutations in tissue extracted by bronchoscopic cryobiopsy (CB was significantly higher compared to other standard biopsy techniques. This prospective, randomized, multicenter, single blinded study evaluates the accuracy of molecular genetic characterization of NSCLC for different cell sampling techniques. Key inclusion criteria are suspected lung cancer or the suspected relapse of known NSCLC that is bronchoscopically visible. Patients will be randomized, either to have a CB or a bronchoscopic forceps biopsy (FB). If indicated, a transbronchial needle aspiration (TBNA) of suspect lymph nodes will be performed. Blood liquid biopsy will be taken before tissue biopsy. The primary endpoint is the detection rate of molecular genetic alterations in NSCLC, using CB and FB. Secondary endpoints are differences in the combined detection of molecular genetic alterations between FB and CB, TBNA and liquid biopsy. This trial plans to recruit 540 patients, with 178 evaluable patients per study cohort. A histopathological and molecular genetic evaluation will be performed by the affiliated pathology departments of the national network for genomic medicine in lung cancer (nNGM), Germany. We will compare the diagnostic value of solid tumor tissue, lymph node cells and liquid biopsy for the molecular genetic characterization of NSCLC. This reflects a real world clinical setting, with potential direct impact on both treatment and survival.
分子改变的检测对于晚期非小细胞肺癌（NSCLC）的个体化治疗至关重要。遗漏可靶向改变可能对患者的无进展生存期和总生存期产生重大影响。尽管分子改变的实验室检测一直在改进，但对于活检技术如何影响不同突变的检测率却知之甚少。在这项回顾性研究中，与其他标准活检技术相比，经支气管冷冻活检（CB）提取的组织中表皮生长因子（EGFR）突变的检测率显著更高。这项前瞻性、随机、多中心、单盲研究评估了不同细胞采样技术对NSCLC进行分子遗传特征分析的准确性。关键纳入标准为疑似肺癌或已知NSCLC的疑似复发且在支气管镜下可见。患者将被随机分组，要么接受CB，要么接受支气管镜钳夹活检（FB）。如果有指征，将对可疑淋巴结进行经支气管针吸活检（TBNA）。在组织活检前采集血液进行液体活检。主要终点是使用CB和FB检测NSCLC中分子遗传改变的发生率。次要终点是FB和CB、TBNA与液体活检在分子遗传改变联合检测方面的差异。该试验计划招募540名患者，每个研究队列有178名可评估患者。德国肺癌基因组医学国家网络（nNGM）的附属病理科将进行组织病理学和分子遗传学评估。我们将比较实体瘤组织、淋巴结细胞和液体活检对NSCLC分子遗传特征分析的诊断价值。这反映了真实世界的临床情况，可能对治疗和生存产生直接影响。
