Department of Thoracic Medical Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Division of Pathology, Cancer Institute, Japanese Foundation for Cancer Research, Tokyo, Japan.
Thorac Cancer. 2021 Feb;12(4):504-511. doi: 10.1111/1759-7714.13786. Epub 2020 Dec 21.
The usefulness of the Oncomine Dx Target test (Oncomine Dx), a next-generation sequencing (NGS) test, has already been proven in clinical trials. However, NGS requires high-quality tumor samples and takes a long time to generate results. The feasibility of NGS for use in advanced non-small cell lung cancer (NSCLC) patients in clinical practice has not yet been determined.
Patients serially diagnosed with advanced NSCLC were evaluated in our hospital. The Oncomine Dx, Cobas EGFR mutation test (Cobas EGFR), and ALK-IHC were performed. The patients were divided into four sets: the full analysis set (FAS) that referred to patients diagnosed with NSCLC, the intent to perform companion diagnostics (CDx) set (IPS) that referred to patients in which CDx had been ordered regardless of sample quality, the per-performed CDx set (PPS) that referred to patients who could undergo CDx regardless of the results, and the per-completed CDx set (CCS) that referred to patients in which informative results were received from the CDx.
The total number of patients analyzed in the study was 167. The IPS/FAS of Oncomine Dx (80.2%) was lower than that of the ALK-IHC (85.0%) and Cobas EGFR (92.8%). The CCS/FAS of Oncomine Dx (65.9%) was lower than that of the ALK-IHC (82.0%) and Cobas EGFR (92.2%). PPS/IPS and CCS/PPS of the Oncomine Dx with nonsurgical biopsy ranged between 78.6% and 90.9%, which was lower than those patients who underwent surgical resection (95.0% and 100%).
The feasibility of Oncomine Dx in clinical practice was lower than the other CDx. The feasibility of Oncomine Dx will increase by improving the biopsy procedure.
SIGNIFICANT STUDY FINDINGS: The usefulness of a next-generation sequencing (NGS) test has been proven in clinical trials. The feasibility of NGS is lower than other diagnostics in clinical practice especially with regard to nonsurgical biopsy.
It is necessary to improve the feasibility of NGS in clinical practice. To improve NGS feasibility, turnaround time must be shortened, and larger samples must be obtained during surgical procedures.
下一代测序（NGS）检测 Oncomine Dx Target 测试（Oncomine Dx）的有效性已在临床试验中得到证实。然而，NGS 需要高质量的肿瘤样本，并且需要很长时间才能得出结果。NGS 在临床实践中用于晚期非小细胞肺癌（NSCLC）患者的可行性尚未确定。
在我院连续评估了经病理诊断为晚期 NSCLC 的患者。进行了 Oncomine Dx、Cobas EGFR 突变检测（Cobas EGFR）和 ALK-IHC。将患者分为四组：全分析集（FAS），指被诊断为 NSCLC 的患者；意向进行伴随诊断（CDx）集（IPS），指无论样本质量如何，均已订购 CDx 的患者；可进行 CDx 的患者集（PPS），指无论 CDx 结果如何，均可进行 CDx 的患者；可获得 CDx 信息性结果的患者集（CCS），指从 CDx 获得信息性结果的患者。
本研究共分析了 167 例患者。Oncomine Dx 的 IPS/FAS（80.2%）低于 ALK-IHC（85.0%）和 Cobas EGFR（92.8%）。Oncomine Dx 的 CCS/FAS（65.9%）低于 ALK-IHC（82.0%）和 Cobas EGFR（92.2%）。Oncomine Dx 非手术活检的 PPS/IPS 和 CCS/PPS 范围为 78.6%~90.9%，低于接受手术切除的患者（95.0%和 100%）。
Oncomine Dx 在临床实践中的可行性低于其他 CDx。通过改进活检程序，可提高 Oncomine Dx 的可行性。
重要研究结果：下一代测序（NGS）检测的有效性已在临床试验中得到证实。NGS 的可行性低于其他诊断方法，尤其是在非手术活检方面。
需要提高 NGS 在临床实践中的可行性。要提高 NGS 的可行性，必须缩短周转时间，并在手术过程中获得更大的样本。
