Feasibility and utility of a panel testing for 114 cancer-associated genes in a clinical setting: A hospital-based study.

Sunami K1, Ichikawa H2,3, Kubo T1,2,3, Kato M4, Fujiwara Y5, Shimomura A5, Koyama T5, Kakishima H1, Kitami M1, Matsushita H1, Furukawa E4, Narushima D4, Nagai M4, Taniguchi H1, Motoi N1, Sekine S1, Maeshima A1, Mori T1, Watanabe R1, Yoshida M1, Yoshida A1, Yoshida H1, Satomi K1, Sukeda A1, Hashimoto T1, Shimizu T5, Iwasa S5, Yonemori K5, Kato K6, Morizane C7, Ogawa C8, Tanabe N9, Sugano K9,10, Hiraoka N1, Tamura K11, Yoshida T9, Fujiwara Y12, Ochiai A1,13, Yamamoto N5, Kohno T3,14.

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Abstract

Next generation sequencing (NGS) of tumor tissue (i.e., clinical sequencing) can guide clinical management by providing information about actionable gene aberrations that have diagnostic and therapeutic significance. Here, we performed a hospital-based prospective study (TOP-GEAR project, 2nd stage) to investigate the feasibility and utility of NGS-based analysis of 114 cancer-associated genes (the NCC Oncopanel test). We examined 230 cases (comprising > 30 tumor types) of advanced solid tumors, all of which were matched with non-tumor samples. Gene profiling data were obtained for 187 cases (81.3%), 111 (59.4%) of which harbored actionable gene aberrations according to the Clinical Practice Guidelines for Next Generation Sequencing in Cancer Diagnosis and Treatment (Edition 1.0) issued by three major Japanese cancer-related societies. Twenty-five (13.3%) cases have since received molecular-targeted therapy according to their gene aberrations. These results demonstrate the utility of tumor-profiling multiplex gene panel testing in a clinical setting in Japan. This study is registered with UMIN Clinical Trials Registry (UMIN000011141). This article is protected by copyright. All rights reserved.