Some multi-gene panel tests have been implemented in clinical settings to guide targeted therapy in non-small-cell lung cancer (NSCLC) in Japan. The current performance of multi-gene panel tests under the condition that the Oncomine Dx Target Test (ODxTT) and Amoy Dx®Pan Lung Cancer PCR panel (AmoyDx-multi) are available remains relatively unknown. We retrospectively reviewed consecutive patients with NSCLC, whose FFPE samples were considered for genetic testing. We assessed the submission rates, the success rates, and the driver oncogene detection rates of multi-gene panel tests. A total of 225 patients were histologically newly diagnosed with NSCLC or diagnosed with a recurrence of NSCLC without a previous multi-gene panel test at our institution. Among the 225 patients, the FFPE samples of 212 patients (94.2%) were submitted for multi-gene panel testing, including 191 samples (84.9%) for the ODxTT and 21 samples (9.3%) for the AmoyDx-multi. Among the 212 samples submitted to multi-gene panel tests, the success rate was 99.5% (211/212). The detection rate of driver oncogene alterations for all histologies was 52.4% (111/212), and that for adenocarcinoma was 69.7% (106/152). A favorable submission rate and success rate of multi-gene panel tests were shown, along with a favorable detection rate in recent clinical settings.
在日本临床实践中,已采用部分多基因组合检测指导非小细胞肺癌(NSCLC)的靶向治疗。当前在Oncomine Dx靶向检测(ODxTT)与AmoyDx®泛肺癌PCR组合检测(AmoyDx-multi)可及的情况下,多基因组合检测的实际应用效能尚不明确。本研究回顾性分析了连续入组的NSCLC患者,其福尔马林固定石蜡包埋(FFPE)样本均被纳入基因检测考量。我们系统评估了多基因组合检测的送检率、检测成功率及驱动癌基因检出率。研究共纳入225例经组织学新确诊或既往未接受多基因检测的NSCLC复发患者。其中212例(94.2%)患者的FFPE样本被送检多基因组合检测,包括191例(84.9%)采用ODxTT检测及21例(9.3%)采用AmoyDx-multi检测。在送检的212例样本中,检测成功率达99.5%(211/212)。全组织学类型的驱动癌基因变异检出率为52.4%(111/212),其中腺癌亚型检出率达69.7%(106/152)。研究表明在当前临床实践中,多基因组合检测呈现出良好的送检率与检测成功率,同时展现出理想的驱动基因检出效能。