Feasibility of next-generation sequencing test for patients with advanced NSCLC in clinical practice.
Feasibility of next-generation sequencing test for patients with advanced NSCLC in clinical practice.
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DOI：
10.1111/1759-7714.13786
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发表时间：
2021-03
期刊：
影响因子：
2.9
通讯作者：
Nishio M
中科院分区：
文献类型：
--
作者：
Ariyasu R;Uchibori K;Ninomiya H;Ogusu S;Tsugitomi R;Manabe R;Sakamaoto H;Tozuka T;Yoshida H;Amino Y;Kitazono S;Yanagitani N;Takeuchi K;Nishio M
Oncomine Dx Target 测试 (Oncomine Dx) 是一种下一代测序 (NGS) 测试，其实用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。在我们医院对连续诊断为晚期 NSCLC 的患者进行了评估。进行了 Oncomine Dx、Cobas EGFR 突变测试 (Cobas EGFR) 和 ALK-IHC。患者被分为四组：完整分析组（FAS）指的是诊断为 NSCLC 的患者；意向执行伴随诊断（CDx）组（IPS）指的是无论样本质量如何都已安排 CDx 的患者；执行 CDx 组（PPS）指的是无论结果如何都可以接受 CDx 的患者；完成 CDx 组（CCS）指的是从 CDx 收到信息性结果的患者。该研究分析的患者总数为 167 例。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 范围在 78.6% 至 90.9% 之间，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。 Oncomine Dx 的可行性将通过改进活检程序而增加。下一代测序（NGS）测试的有用性已在临床试验中得到证实。 NGS 在临床实践中的可行性低于其他诊断方法，尤其是在非手术活检方面。有必要提高NGS在临床实践中的可行性。为了提高NGS的可行性，必须缩短周转时间，并且必须在外科手术过程中获得更大的样本。与 ALK-IHC 和 Cobas EGFR 相比，Oncomine Dx 在临床实践中的可行性相对较低。
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. 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. The feasibility of Oncomine Dx in clinical practice is relatively low compared with that of the ALK‐IHC and Cobas EGFR.
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影响因子：
51.1
作者：
Mitsudomi, Tetsuya;Morita, Satoshi;Fukuoka, Masahiro
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