Real-world data on NGS using the Oncomine DxTT for detecting genetic alterations in non-small-cell lung cancer: WJOG13019L.
Real-world data on NGS using the Oncomine DxTT for detecting genetic alterations in non-small-cell lung cancer: WJOG13019L.
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DOI：
10.1111/cas.15176
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发表时间：
2022-01
期刊：
影响因子：
5.7
通讯作者：
Nakagawa K
中科院分区：
文献类型：
--
作者：
Sakata S;Otsubo K;Yoshida H;Ito K;Nakamura A;Teraoka S;Matsumoto N;Shiraishi Y;Haratani K;Tamiya M;Ikeda S;Miura S;Tanizaki J;Omori S;Yoshioka H;Hata A;Yamamoto N;Nakagawa K
考虑到发现的致癌基因改变的数量越来越多，需要进行额外的基因测试来确定晚期非小细胞肺癌(NSCLC)的治疗。下一代测序可以同时检测多个致癌基因，从而能够分析有限数量的活组织样本。在这项多中心的回顾性研究中(UMIN ID000039523)，我们使用Oncomine Dx靶测试多CDX系统(Oncomine DxTT)作为辅助诊断系统来评估真实世界的临床数据。在2019年6月至2020年1月期间使用Oncomine DxTT对46个基因进行测试的NSCLC患者有资格参加登记。受试者来自西日本肿瘤学集团下属的19个机构。研究的主要终点是使用Oncomine DxTT对四个驱动基因(EGFR、ALK、ROS1和BRAF)进行基因改变检测的成功率。总共有533名患者参加了这项研究。4种基因突变检测的成功率均为80.1%(95%可信区间为76.5%~83.4%)。手术切除成功率最高(88.0%)，显著高于支气管镜活检(76.8%，P=0.005)。多因素分析显示，单纯手术切除组差异有统计学意义(P=0.006，95%可信区间1.36~6.18，优势比2.90)。在本研究中，虽然在DxTT诱导后立即进行基因突变检测的成功率不够高，但优化样本数量和质量可能会提高司机基因检测在临床中的应用。4个基因的突变鉴定成功率均为80.1%。手术切除与最高成功率相关。多因素分析显示单纯手术切除有显著差异。
Considering the increasing number of identified driver oncogene alterations, additional genetic tests are required to determine the treatment for advanced non‐small‐cell lung cancer (NSCLC). Next‐generation sequencing can detect multiple driver oncogenes simultaneously, enabling the analysis of limited amounts of biopsied tissue samples. In this retrospective, multicenter study (UMIN ID000039523), we evaluated real‐world clinical data using the Oncomine Dx Target Test Multi‐CDx System (Oncomine DxTT) as a companion diagnostic system. Patients with NSCLC who were tested for a panel of 46 genes using the Oncomine DxTT between June 2019 and January 2020 were eligible for enrollment. Patients from 19 institutions affiliated to the West Japan Oncology Group were recruited. The primary endpoint of the study was the success rate of genetic alteration testing in four driver genes (EGFR, ALK, ROS1, and BRAF) using the Oncomine DxTT. In total, 533 patients were enrolled in the study. The success rate of genetic alteration testing for all four genes was 80.1% (95% CI 76.5%‐83.4%). Surgical resection was associated with the highest success rate (88.0%), which was significantly higher than that for bronchoscopic biopsy (76.8%, P = .005). Multivariate analysis revealed a significant difference for surgical resection alone (P = .006, 95% CI 1.36‐6.18, odds ratio 2.90). Although the success rate of genetic alteration testing immediately after Oncomine DxTT induction was not sufficient in this study, optimizing specimen quantity and quality may improve the use of driver gene testing in clinical settings. The mutation identification success rate for all four genes was 80.1%. Surgical resection was associated with the highest success rate. Multivariate analysis showed a significant difference for surgical resection alone.
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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
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