Journal Article

Real‐world data on NGS using the Oncomine DxTT for detecting genetic alterations in non‐small‐cell lung cancer: WJOG13019L

Yamamoto, Nobuyuki, Teraoka, Shunsuke, Omori, Shota, Tamiya, Motohiro, Tanizaki, Junko, Nakamura, Atsushi, Haratani, Koji, Hata, Akito, Nakagawa, Kazuhiko, Shiraishi, Yoshimasa, Yoshioka, Hiroshige, Miura, Satoru, Otsubo, Kohei, Sakata, Shinya, Matsumoto, Naohisa, Yoshida, Hisako, Ikeda, Satoshi, Ito, Kentaro

2022

Overview

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.

• Publisher: John Wiley & Sons, Inc,John Wiley and Sons Inc
• Subject: Adult / Aged / Aged, 80 and over / Anaplastic Lymphoma Kinase - genetics / Biopsy / Carcinoma, Non-Small-Cell Lung - genetics / Carcinoma, Non-Small-Cell Lung - surgery / Dissection / ErbB Receptors - genetics / Female / Genes / Genetic screening / Genetic Testing - methods / High-Throughput Nucleotide Sequencing / Humans / Kinases / Laboratories / Lung cancer / Lung Neoplasms - genetics / Lung Neoplasms - surgery / Male / Middle Aged / Multivariate Analysis / Mutation / next‐generation sequencing gene panel / Non-small cell lung carcinoma / non‐small‐cell lung cancer / Oncomine Dx / Original / Patients / Prognosis / Protein-Tyrosine Kinases - genetics / Proto-Oncogene Proteins - genetics / Proto-Oncogene Proteins B-raf - genetics / Retrospective Studies / Sequence Analysis, DNA / Success / Treatment Outcome / turnaround time