Multiple Biomarker Testing Tissue Consumption and Completion Rates With Single-gene Tests and Investigational Use of Oncomine Dx Target Test for Advanced Non-Small-cell Lung Cancer: A Single-center Analysis
Multiple Biomarker Testing Tissue Consumption and Completion Rates With Single-gene Tests and Investigational Use of Oncomine Dx Target Test for Advanced Non-Small-cell Lung Cancer: A Single-center Analysis
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DOI：
10.1016/j.cllc.2018.08.010
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发表时间：
2019-01-01
影响因子：
3.6
通讯作者：
Layton, Andrew J.
中科院分区：
文献类型：
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作者：
Yu, Tiffany M.;Morrison, Carl;Layton, Andrew J.
与非小细胞肺癌治疗相关的基因数量不断增加，再加上肺组织样本量较小，这就增加了对组织管理的需求，以实现多种生物标志物检测。本回顾性分析评价了1402份临床医生提交的样本中的3659项单基因检测和169项研究性Oncomine Dx靶标检测。与单基因检测相比，Oncomine Dx靶向检测试剂盒可成功检测小样本的多种生物标志物。引言：一线靶向治疗已被开发用于晚期非小细胞肺癌（NSCLC）。然而，小活检样本对测试所有相关生物标志物构成挑战。本研究表征了临床医生订购的单基因肺癌检测，并评估了组织管理以及通过单基因检测或Oncomine Dx Target Test的研究性使用成功确定突变状态的能力。材料与方法：回顾性评价了临床医生提交的1402份样本中3659项单基因检测（EGFR、ALK、ROS 1、BRAF、KRAS、ERBB 2、MET、RET、FGFR 1）的订单，以及169项试验用Oncomine Dx靶标检测。通过样本类型、测试类型和每个样本的单基因测试数量来评估测试成功率和组织消耗。结果如下：提交用于临床试验的绝大多数肺组织样本较小（70.5%粗针活检; 10.0%细针抽吸）。通过单基因检测，88.4%的临床样本成功报告了>= 1个生物标志物的突变状态。随着额外生物标志物的检测，成功率降低，组织消耗增加。研究性Oncomine Dx靶向检测允许各使用1张组织载玻片，并且对于空芯针活检>= 5个生物标志物、细针抽吸>= 4个生物标志物和手术切除标本>= 2个生物标志物，成功率与单基因检测相似。结论：组织管理对于成功完成基因检测和做出明智的NSCLC治疗决策非常重要。对研究性Oncomine Dx Target Test的初步评估表明，它可以促进使用小组织样本进行多种生物标志物检测，以支持晚期NSCLC患者的治疗决策。(C)2018作者（S）爱思唯尔公司出版
The increasing number of genes relevant to non-small-cell lung cancer treatment, combined with small lung tissue samples, has heightened the need for tissue stewardship to enable multiple biomarker testing. The present retrospective analysis evaluated 3659 single-gene tests across 1402 clinician-submitted samples and 169 investigational Oncomine Dx Target Tests. Compared with single-gene testing, the Oncomine Dx Target Test could facilitate successful multiple biomarker testing of small samples.Introduction: First-line targeted therapies have been developed for advanced non-small-cell lung cancer (NSCLC). However, small biopsy samples pose a challenge to testing all relevant biomarkers. The present study characterized clinician-ordered single-gene lung cancer testing and evaluated tissue stewardship and the ability to successfully determine mutation status with single-gene testing or investigational use of the Oncomine Dx Target Test. Materials and Methods: Clinician-submitted orders for 3659 single-gene tests (EGFR, ALK, ROS1, BRAF, KRAS, ERBB2, MET, RET, FGFR1) across 1402 samples at a large US-based commercial reference laboratory and 169 investigational Oncomine Dx Target Tests were retrospectively evaluated. The testing success rates and tissue consumption were evaluated by sample type, test type, and number of single-gene tests per sample. Results: The large majority of lung tissue samples submitted for clinical testing were small (70.5% core needle biopsies; 10.0% fine needle aspirations). With single-gene testing, mutation status was successfully reported for >= 1 biomarker for 88.4% of the clinical samples. The success rates decreased and tissue consumption increased with testing of additional biomarkers. Investigational Oncomine Dx Target Tests were permitted 1 tissue slide each and demonstrated success rates similar to single-gene testing for >= 5 biomarkers on core needle biopsies, >= 4 biomarkers on fine needle aspirations, and >= 2 biomarkers on surgical resection specimens. Conclusion: Tissue stewardship is important to enable successful completion of genetic testing and informed NSCLC treatment decisions. Preliminary assessment of the investigational Oncomine Dx Target Test suggests it could facilitate access to multiple biomarker testing using small tissue samples to support therapy decisions for patients with advanced NSCLC. (C) 2018 The Author(s). Published by Elsevier Inc.