Affiliations: [a] Department of Respiratory Medicine, Kitasato University School of Medicine, Kanagawa, Japan | [b] Department of Genome Biology, Kindai University Faculty of Medicine, Osaka, Japan | [c] Research and Development Center for New Medical Frontiers, Kitasato University School of Medicine, Kanagawa, Japan | [d] Fundamental Nursing, Kitasato University School of Nursing, Kanagawa, Japan | [e] Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan
Correspondence:
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Corresponding author: Tomoya Fukui, Department of Respiratory Medicine, Kitasato University School of Medicine, 1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0374, Japan. Tel.: +81 42 778 8506; Fax: +81 42 778 6412; E-mail: [email protected].
Abstract: BACKGROUND: The advancement of cancer genomics has allowed for multiplex gene assays using next-generation sequencing (NGS) to be practically implemented, however, a clinical practice system remains to be established. OBJECTIVE: We evaluated the feasibility of clinical sequencing using NGS-based multiplex gene assays between cooperating medical institutions in patients with advanced cancers. METHODS: In this observational study, DNA and RNA samples prepared from existing tumor tissues were subjected to comprehensive genomic profiling using targeted sequencing. RESULTS: From January 2017 to March 2019, 36 samples from 33 patients were assessed. Of all patients, 27 (82%) had lung cancer, with the median age of 50 years (range 38–83). Multiplex gene panel tests were successfully carried out on 35/36 (97%) samples. Potentially actionable gene alterations were identified in 10/30 (33%) samples (3 HER2, 2 KRAS, 2 ALK, 1 PIK3CA, 1 RET, and 1 CDKN2A). In the 6 samples examined for resistant mechanisms, ALK I1171N mutation and MET copy number gain were detected in 2 patients with ALK rearrangement-positive lung cancer. CONCLUSIONS: Clinical sequencing using NGS-based multiplex gene assays between collaborating domestic medical institutions was feasible, with a success rate of > 97%. Overall, clinical sequencing benefits therapeutic decision-making in patients with advanced cancer.
