Clinical practice guidance for next‐generation sequencing in cancer diagnosis and treatment (Edition 1.0)

  • Kuniko Sunami
    Department of Pathology and Clinical Laboratories National Cancer Center Hospital Tokyo Japan
  • Hideaki Takahashi
    Department of Hepatobiliary and Pancreatic Oncology National Cancer Center Hospital East Kashiwa Japan
  • Katsuya Tsuchihara
    Division of Translational Informatics Exploratory Oncology Research and Clinical Trial Center National Cancer Center Kashiwa Japan
  • Masayuki Takeda
    Department of Medical Oncology Kindai University Faculty of Medicine Osaka Japan
  • Tatsuya Suzuki
    Department of Hematology National Cancer Center Hospital Tokyo Japan
  • Yoichi Naito
    Department of Breast and Medical Oncology National Cancer Center Hospital East Kashiwa Japan
  • Kazuko Sakai
    Department of Genome Biology Kindai University Faculty of Medicine Osaka Japan
  • Hirotoshi Dosaka‐Akita
    Department of Medical Oncology Hokkaido University Graduate School of Medicine Hokkaido Japan
  • Chikashi Ishioka
    Department of Medical Oncology Tohoku University Hospital Miyagi Japan
  • Yasuhiro Kodera
    Department of Gastroenterological Surgery Nagoya University Graduate School of Medicine Aichi Japan
  • Manabu Muto
    Department of Therapeutic Oncology Graduate School of Medicine Kyoto University Kyoto Japan
  • Toshifumi Wakai
    Division of Digestive and General Surgery Niigata University Graduate School of Medical and Dental Sciences Niigata Japan
  • Kentaro Yamazaki
    Division of Gastrointestinal Oncology Shizuoka Cancer Center Shizuoka Japan
  • Wataru Yasui
    Department of Molecular Pathology Hiroshima University Hiroshima Japan
  • Hideaki Bando
    Department of Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan
  • Yumi Fujimoto
    Department of Breast and Medical Oncology National Cancer Center Hospital East Kashiwa Japan
  • Shota Fukuoka
    Department of Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan
  • Kenichi Harano
    Department of Breast and Medical Oncology National Cancer Center Hospital East Kashiwa Japan
  • Akihito Kawazoe
    Department of Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan
  • Gen Kimura
    Department of Hepatobiliary and Pancreatic Oncology National Cancer Center Hospital East Kashiwa Japan
  • Shigehiro Koganemaru
    Department of Experimental Therapeutics National Cancer Center Hospital East Kashiwa Japan
  • Takahiro Kogawa
    Department of Breast and Medical Oncology National Cancer Center Hospital East Kashiwa Japan
  • Daisuke Kotani
    Department of Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan
  • Yasutoshi Kuboki
    Department of Experimental Therapeutics National Cancer Center Hospital East Kashiwa Japan
  • Hiroshi Matsumoto
    Department of Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan
  • Shingo Matsumoto
    Department of Thoracic Oncology National Cancer Center Hospital East Kashiwa Japan
  • Saori Mishima
    Department of Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan
  • Yoshiaki Nakamura
    Department of Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan
  • Kentaro Sawada
    Department of Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan
  • Sumito Shingaki
    Department of Experimental Therapeutics National Cancer Center Hospital East Kashiwa Japan
  • Kohei Shitara
    Department of Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan
  • Kumiko Umemoto
    Department of Hepatobiliary and Pancreatic Oncology National Cancer Center Hospital East Kashiwa Japan
  • Shigeki Umemura
    Department of Thoracic Oncology National Cancer Center Hospital East Kashiwa Japan
  • Kayo Yasuda
    Department of Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan
  • Takayuki Yoshino
    Department of Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan
  • Noboru Yamamoto
    Department of Experimental Therapeutics National Cancer Center Hospital Tokyo Japan
  • Kazuto Nishio
    Department of Genome Biology Kindai University Faculty of Medicine Osaka Japan

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<jats:p>In Japan, the social (medical) health‐care system is on the way to being developed to advance personalized medicine through the implementation of cancer genomic medicine, known as “cancer clinical sequencing,” which uses a next‐generation sequencer. However, no Japanese guidance for cancer genomic testing exists. Gene panel testing can be carried out to help determine patient treatment, confirm diagnosis, and evaluate prognostic predictions of patients with mainly solid cancers for whom no standard treatment is available. This guidance describes how to utilize gene panel testing according to the type of cancer: childhood cancer, rare cancer, carcinoma of unknown primary, and other cancers. The level of evidence classification for unified use in Japan is also detailed. This guidance establishes the basic principles of the quality control of specimens, requirements of medical institutions, informed consent, handling of data during the postanalysis stage, and treatment options based on the evidence level. In Japan, gene panel testing for cancer treatment and diagnosis is recommended to comply with this guidance. This is a collaborative work of the Japanese Society of Medical Oncology, Japan Society of Clinical Oncology, and the Japanese Cancer Association.</jats:p>

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