Yoichi Naito1, Hiroyuki Aburatani2, Toraji Amano3, Eishi Baba4, Toru Furukawa5, Tetsu Hayashida6, Eiso Hiyama7, Sadakatsu Ikeda8, Masashi Kanai9, Motohiro Kato10, Ichiro Kinoshita11, Naomi Kiyota12, Takashi Kohno13, Shinji Kohsaka14, Keigo Komine15, Itaru Matsumura16, Yuji Miura17, Yoshiaki Nakamura18, Atsushi Natsume19, Kazuto Nishio20, Katsutoshi Oda21, Naoyuki Oda22, Natsuko Okita23, Kumiko Oseto24,25, Kuniko Sunami26, Hideaki Takahashi27, Masayuki Takeda28, Shimon Tashiro29, Shinichi Toyooka30, Hideki Ueno31, Shinichi Yachida32, Takayuki Yoshino18, Katsuya Tsuchihara33. 1. Department of General Internal Medicine/Breast and Medical Oncology/Experimental Therapeutics, National Cancer Center Hospital East, Kashiwa, Japan. 2. Genome Science Division, Research Center for Advanced Science and Technology, University of Tokyo, Tokyo, Japan. 3. Clinical Research and Medical Innovation Center, Hokkaido University Hospital, Sapporo, Japan. 4. Department of Oncology and Social Medicine, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. 5. Department of Investigative Pathology, Tohoku University Graduate School of Medicine, Sendai, Japan. 6. Department of Surgery, Keio University School of Medicine, Tokyo, Japan. 7. Natural Science Center for Basic Research and Development, Hiroshima University, Hiroshima, Japan. 8. Cancer Center, Tokyo Medical and Dental University, Tokyo, Japan. 9. Department of Clinical Oncology, Kyoto University Hospital, Kyoto, Japan. 10. Children's Cancer Center, National Center for Child Health and Development, Tokyo, Japan. 11. Division of Clinical Cancer Genomics, Hokkaido University Hospital, Sapporo, Japan. 12. Kobe University Hospital Cancer Center, Kobe, Japan. 13. Division of Genome Biology, National Cancer Center Research Institute, Tokyo, Japan. 14. Division of Cellular Signaling, National Cancer Center Research Institute, Tokyo, Japan. 15. Department of Medical Oncology, Tohoku University Hospital, Sendai, Japan. 16. Department of Hematology and Rheumatology, Kindai University Faculty of Medicine, Osakasayama, Japan. 17. Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan. 18. Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. 19. Department of Neurosurgery, Nagoya University, Nagoya, Japan. 20. Department of Genome Biology, Kindai University Faculty of Medicine, Osakasayama, Japan. 21. Department of Obstetrics and Gynecology, Faculty of Medicine, The University of Tokyo, Tokyo, Japan. 22. Section of Information Technology Support, Center for Cancer Genomics and Advanced Therapeutics, National Cancer Center, Tokyo, Japan. 23. Clinical Research Support Office, National Cancer Center Hospital, Tokyo, Japan. 24. Department of Clinical Genomics, The University of Tokyo, Tokyo, Japan. 25. Konica Minolta Precision Medicine Japan, Inc., Tokyo, Japan. 26. Department of Laboratory Medicine, National Cancer Center Hospital, Tokyo, Japan. 27. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan. 28. Medical Oncology, Kindai University Faculty of Medicine, Osakasayama, Japan. 29. Department of Sociology, Graduate School of Arts and Letters, Tohoku University, Sendai, Japan. 30. Department of General Thoracic Surgery and Breast and Endocrine Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan. 31. Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan. 32. Department of Cancer Genome Informatics, Graduate School of Medicine, Osaka University, Osaka, Japan. 33. Division of Translational Informatics, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. ktsuchih@east.ncc.go.jp.
Abstract
BACKGROUND: To promote precision oncology in clinical practice, the Japanese Society of Medical Oncology, the Japanese Society of Clinical Oncology, and the Japanese Cancer Association, jointly published "Clinical practice guidance for next-generation sequencing in cancer diagnosis and treatment" in 2017. Since new information on cancer genomic medicine has emerged since the 1st edition of the guidance was released, including reimbursement for NGS-based multiplex gene panel tests in 2019, the guidance revision was made. METHODS: A working group was organized with 33 researchers from cancer genomic medicine designated core hospitals and other academic institutions. For an impartial evaluation of the draft version, eight committee members from each society conducted an external evaluation. Public comments were also made on the draft. The finalized Japanese version was published on the websites of the three societies in March 2020. RESULTS: The revised edition consists of two parts: an explanation of the cancer genomic profiling test (General Discussion) and clinical questions (CQs) that are of concern in clinical practice. Particularly, patient selection should be based on the expectation that the patient's post-test general condition and organ function will be able to tolerate drug therapy, and the optimal timing of test should be considered in consideration of subsequent treatment plans, not limited to treatment lines. CONCLUSION: We expect that the revised version will be used by healthcare professionals and will also need to be continually reviewed in line with future developments in cancer genome medicine.
BACKGROUND: To promote precision oncology in clinical practice, the Japanese Society of Medical Oncology, the Japanese Society of Clinical Oncology, and the Japanese Cancer Association, jointly published "Clinical practice guidance for next-generation sequencing in cancer diagnosis and treatment" in 2017. Since new information on cancer genomic medicine has emerged since the 1st edition of the guidance was released, including reimbursement for NGS-based multiplex gene panel tests in 2019, the guidance revision was made. METHODS: A working group was organized with 33 researchers from cancer genomic medicine designated core hospitals and other academic institutions. For an impartial evaluation of the draft version, eight committee members from each society conducted an external evaluation. Public comments were also made on the draft. The finalized Japanese version was published on the websites of the three societies in March 2020. RESULTS: The revised edition consists of two parts: an explanation of the cancer genomic profiling test (General Discussion) and clinical questions (CQs) that are of concern in clinical practice. Particularly, patient selection should be based on the expectation that the patient's post-test general condition and organ function will be able to tolerate drug therapy, and the optimal timing of test should be considered in consideration of subsequent treatment plans, not limited to treatment lines. CONCLUSION: We expect that the revised version will be used by healthcare professionals and will also need to be continually reviewed in line with future developments in cancer genome medicine.
Entities:
Keywords:
Cancer genomic profiling test; Clinical practice guidance; Next-generation sequencing; Solid cancer
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