{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T21:44:29Z","timestamp":1788212669943,"version":"build-2803163510"},"reference-count":40,"publisher":"MDPI AG","issue":"5","license":[{"start":{"date-parts":[[2021,3,5]],"date-time":"2021-03-05T00:00:00Z","timestamp":1614902400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Next-generation sequencing (NGS) assay is part of routine care in Japan owing to its reimbursement by Japan\u2019s universal health-care system; however, reimbursement is limited to patients who finished standard treatment. We retrospectively investigated 221 patients who underwent Foundation One CDX (F1CDx) at our hospital. Every F1CDx result was assessed at the molecular tumor board (MTB) for treatment recommendation. Based on patients\u2019 preferences, presumed germline findings were also assessed at the MTB and disclosed at the clinic. In total, 204 patients underwent F1CDx and 195 patients completed the analysis; however, 13.8% of them could not receive the report due to disease progression. Among 168 patients who received the results, 41.6% had at least one actionable alteration, and 3.6% received genomically matched treatment. Presumed germline findings were nominated in 24 patients, and 16.7% of them contacted a geneticist counselor. The NGS assay should be performed earlier in the clinical course to maximize the clinical benefit. Broader reimbursement for the NGS assay would enhance the delivery of precision oncology to patients. Access to clinical trials affects the number of patients who benefit from NGS. Additionally, the disclosure of presumed germline findings is feasible in clinical practice.<\/jats:p>","DOI":"10.3390\/cancers13051121","type":"journal-article","created":{"date-parts":[[2021,3,5]],"date-time":"2021-03-05T11:46:09Z","timestamp":1614944769000},"page":"1121","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Clinical Utility of Next-Generation Sequencing-Based Panel Testing under the Universal Health-Care System in Japan: A Retrospective Analysis at a Single University Hospital"],"prefix":"10.3390","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1282-232X","authenticated-orcid":false,"given":"Chiaki","family":"Inagaki","sequence":"first","affiliation":[{"name":"Department of Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daichi","family":"Maeda","sequence":"additional","affiliation":[{"name":"Department of Clinical Genomics, Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazue","family":"Hatake","sequence":"additional","affiliation":[{"name":"Center for Cancer Genomics and Personalized Medicine, Osaka University Hospital, Osaka 565-0871, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuki","family":"Sato","sequence":"additional","affiliation":[{"name":"Department of Genetic Counseling, Osaka University Hospital, Osaka 565-0871, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kae","family":"Hashimoto","sequence":"additional","affiliation":[{"name":"Department of Genetic Counseling, Osaka University Hospital, Osaka 565-0871, Japan"},{"name":"Department of Obstetrics and Gynecology, Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Sakai","sequence":"additional","affiliation":[{"name":"Center for Cancer Genomics and Personalized Medicine, Osaka University Hospital, Osaka 565-0871, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinichi","family":"Yachida","sequence":"additional","affiliation":[{"name":"Center for Cancer Genomics and Personalized Medicine, Osaka University Hospital, Osaka 565-0871, Japan"},{"name":"Department of Cancer Genome Informatics, Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norio","family":"Nonomura","sequence":"additional","affiliation":[{"name":"Center for Cancer Genomics and Personalized Medicine, Osaka University Hospital, Osaka 565-0871, Japan"},{"name":"Department of Urology, Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4615-2638","authenticated-orcid":false,"given":"Taroh","family":"Satoh","sequence":"additional","affiliation":[{"name":"Department of Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Osaka 565-0871, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2021,3,5]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"56491","DOI":"10.18632\/oncotarget.10606","article-title":"Clinical benefit of a precision medicine based approach for guiding treatment of refractory cancers","volume":"7","author":"Radovich","year":"2016","journal-title":"Oncotarget"},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"536","DOI":"10.1200\/JCO.2017.75.3780","article-title":"Targeted Therapy for Advanced Solid Tumors on the Basis of Molecular Profiles: Results From MyPathway, an Open-Label, Phase IIa Multiple Basket Study","volume":"36","author":"Hainsworth","year":"2018","journal-title":"J. Clin. Oncol."},{"key":"ref_3","doi-asserted-by":"crossref","unstructured":"Mangat, P.K., Halabi, S., Bruinooge, S.S., Garrett-Mayer, E., Alva, A., Janeway, K.A., Stella, P.J., Voest, E., Yost, K.J., and Perlmutter, J. (2018). Rationale and Design of the Targeted Agent and Profiling Utilization Registry (TAPUR) Study. JCO Precis. Oncol., 2018.","DOI":"10.1200\/PO.18.00122"},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"586","DOI":"10.1158\/2159-8290.CD-16-1396","article-title":"High-Throughput Genomics and Clinical Outcome in Hard-to-Treat Advanced Cancers: Results of the MOSCATO 01 Trial","volume":"7","author":"Massard","year":"2017","journal-title":"Cancer Discov."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"744","DOI":"10.1038\/s41591-019-0407-5","article-title":"Molecular profiling of cancer patients enables personalized combination therapy: The I-PREDICT study","volume":"25","author":"Sicklick","year":"2019","journal-title":"Nat. Med."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"132","DOI":"10.1200\/JCO.2020.38.4_suppl.132","article-title":"Pertuzumab plus trastuzumab (P+T) in patients (Pts) with colorectal cancer (CRC) with ERBB2 amplification or overexpression: Results from the TAPUR Study","volume":"38","author":"Gupta","year":"2020","journal-title":"J. Clin. Oncol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1200\/JCO.2020.38.4_suppl.122","article-title":"Cobimetinib plus vemurafenib (C+V) in patients (Pts) with colorectal cancer (CRC) with BRAF V600E mutations: Results from the TAPUR Study","volume":"38","author":"Klute","year":"2020","journal-title":"J. Clin. Oncol."},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"1014","DOI":"10.1200\/JCO.2019.37.15_suppl.1014","article-title":"Pembrolizumab (P) in patients (pts) with metastatic breast cancer (MBC) with high tumor mutational burden (HTMB): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study","volume":"37","author":"Alva","year":"2019","journal-title":"J. Clin. Oncol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"133","DOI":"10.1200\/JCO.2020.38.4_suppl.133","article-title":"Pembrolizumab (P) in patients (Pts) with colorectal cancer (CRC) with high tumor mutational burden (HTMB): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study","volume":"38","author":"Meiri","year":"2020","journal-title":"J. Clin. Oncol."},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"9041","DOI":"10.1200\/JCO.2019.37.15_suppl.9041","article-title":"Palbociclib (P) in patients (pts) with non-small cell lung cancer (NSCLC) with CDKN2A alterations: Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) Study","volume":"37","author":"Ahn","year":"2019","journal-title":"J. Clin. Oncol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"222","DOI":"10.1111\/ajco.13339","article-title":"Recommendations to improve the clinical adoption of NGS-based cancer diagnostics in Singapore","volume":"16","author":"Tan","year":"2020","journal-title":"Asia Pac. J. Clin. Oncol."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1200\/PO.19.00291","article-title":"Precision Oncology and the Universal Health Coverage System in Japan","volume":"3","author":"Ebi","year":"2019","journal-title":"JCO Precis. Oncol."},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1007\/s10147-020-01831-6","article-title":"Clinical practice guidance for next-generation sequencing in cancer diagnosis and treatment (edition 2.1)","volume":"26","author":"Naito","year":"2021","journal-title":"Int. J. Clin. Oncol."},{"key":"ref_14","doi-asserted-by":"crossref","unstructured":"Takeda, M., Sakai, K., Takahama, T., Fukuoka, K., Nakagawa, K., and Nishio, K. (2019). New Era for Next-Generation Sequencing in Japan. Cancers, 11.","DOI":"10.3390\/cancers11060742"},{"key":"ref_15","doi-asserted-by":"crossref","first-page":"e000675","DOI":"10.1136\/esmoopen-2020-000675","article-title":"Feasibility of next-generation sequencing in clinical practice: Results of a pilot study in the Department of Precision Medicine at the University of Campania \u2018Luigi Vanvitelli\u2019","volume":"5","author":"Poliero","year":"2020","journal-title":"ESMO Open"},{"key":"ref_16","doi-asserted-by":"crossref","first-page":"1480","DOI":"10.1111\/cas.13969","article-title":"Feasibility and utility of a panel testing for 114 cancer-associated genes in a clinical setting: A hospital-based study","volume":"110","author":"Sunami","year":"2019","journal-title":"Cancer Sci."},{"key":"ref_17","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1200\/PO.16.00046","article-title":"Personalized Medicine in the Oncology Clinic: Implementation and Outcomes of the Johns Hopkins Molecular Tumor Board","volume":"1","author":"Dalton","year":"2017","journal-title":"JCO Precis. Oncol."},{"key":"ref_18","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1200\/PO.18.00105","article-title":"Personalized Clinical Decision Making Through Implementation of a Molecular Tumor Board: A German Single-Center Experience","volume":"2","author":"Hoefflin","year":"2018","journal-title":"JCO Precis. Oncol."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1200\/PO.18.00186","article-title":"Precision Oncology in Solid Tumors: A Longitudinal Tertiary Care Center Experience","volume":"2","author":"Sadaps","year":"2018","journal-title":"JCO Precis. Oncol."},{"key":"ref_20","unstructured":"(2021, January 24). Prospective Study for Evaluating Feasibly and Utility of Comprehensive Genomic Profiling Test before Initial Systemic Treatment in Advanced Malignant Solid Tumor Patients. Available online: https:\/\/upload.umin.ac.jp\/cgi-open-bin\/ctr_e\/ctr_view.cgi?recptno=R000046492."},{"key":"ref_21","doi-asserted-by":"crossref","first-page":"2719","DOI":"10.1158\/1078-0432.CCR-17-2494","article-title":"Precision Oncology Decision Support: Current Approaches and Strategies for the Future","volume":"24","author":"Kurnit","year":"2018","journal-title":"Clin. Cancer Res."},{"key":"ref_22","doi-asserted-by":"crossref","first-page":"2051","DOI":"10.1200\/JCO.2014.58.4953","article-title":"Current Status of Single-Agent Phase I Trials in Japan: Toward Globalization","volume":"33","author":"Mizugaki","year":"2015","journal-title":"Int. J. Clin. Oncol."},{"key":"ref_23","doi-asserted-by":"crossref","first-page":"5","DOI":"10.21037\/cco.2019.06.02","article-title":"Challenges and insights of early phase oncology drug development in the Asia-Pacific region","volume":"8","author":"Loong","year":"2019","journal-title":"Chin. Clin. Oncol."},{"key":"ref_24","first-page":"e28049","article-title":"A novel approach for improving drug access using patient-proposed healthcare service","volume":"66","author":"Ishimaru","year":"2019","journal-title":"ABSTRACTS Pediatr. Blood Cancer"},{"key":"ref_25","doi-asserted-by":"crossref","first-page":"5809","DOI":"10.1158\/1078-0432.CCR-20-2989","article-title":"The Paradoxical Effects of COVID-19 on Cancer Care: Current Context and Potential Lasting Impacts","volume":"26","author":"Broom","year":"2020","journal-title":"Clin. Cancer Res."},{"key":"ref_26","doi-asserted-by":"crossref","unstructured":"Tolaney, S.M., Lydon, C.A., Li, T., Dai, J., Standring, A., Legor, K.A., Caparrotta, C.M., Schenker, M.P., Glazer, D.I., and Tayob, N. (2020). The Impact of COVID-19 on Clinical Trial Execution at the Dana-Farber Cancer Institute. JNCI J. Natl. Cancer Inst., djaa144.","DOI":"10.1093\/jnci\/djaa144"},{"key":"ref_27","doi-asserted-by":"crossref","unstructured":"Bun, S., Yonemori, K., Sunadoi, H., Nishigaki, R., Noguchi, E., Okusaka, T., Nishida, T., and Fujiwara, Y. (2020). Safety and Evidence of Off-Label Use of Approved Drugs at the National Cancer Center Hospital in Japan. JCO Oncol. Pract., OP2000131.","DOI":"10.1200\/OP.20.00131"},{"key":"ref_28","doi-asserted-by":"crossref","first-page":"251","DOI":"10.1111\/jcpt.12507","article-title":"Off-label drug use in oncology: A systematic review of literature","volume":"42","author":"Saiyed","year":"2017","journal-title":"J. Clin. Pharm. Ther."},{"key":"ref_29","doi-asserted-by":"crossref","first-page":"55","DOI":"10.1001\/jamainternmed.2015.6058","article-title":"Association of Off-label Drug Use and Adverse Drug Events in an Adult Population","volume":"176","author":"Eguale","year":"2016","journal-title":"JAMA Intern. Med."},{"key":"ref_30","doi-asserted-by":"crossref","first-page":"841","DOI":"10.1007\/s10897-016-0059-2","article-title":"Research Participants\u2019 Preferences for Hypothetical Secondary Results from Genomic Research","volume":"26","author":"Wynn","year":"2017","journal-title":"J. Genet. Couns."},{"key":"ref_31","doi-asserted-by":"crossref","first-page":"932","DOI":"10.1038\/gim.2014.50","article-title":"Public preferences for the return of research results in genetic research: A conjoint analysis","volume":"16","author":"Bridges","year":"2014","journal-title":"Genet. Med."},{"key":"ref_32","doi-asserted-by":"crossref","first-page":"358","DOI":"10.1016\/j.ajhg.2018.07.018","article-title":"Evaluation of Recipients of Positive and Negative Secondary Findings Evaluations in a Hybrid CLIA-Research Sequencing Pilot","volume":"103","author":"Sapp","year":"2018","journal-title":"Am. J. Hum. Genet."},{"key":"ref_33","unstructured":"(2021, February 19). FoundationOne\u00ae CDx Full Specification Information. Available online: https:\/\/www.acessdata.fda.gov\/cdrh_docs\/pdf17\/P170019C.pdf."},{"key":"ref_34","unstructured":"(2021, February 19). FoundationOne\u00ae CDx: Summary of Safety and Effectiveness Data (SSED). Available online: https:\/\/www.acessdata.fda.gov\/cdrh_docs\/pdf17\/P170019S016B.pdf."},{"key":"ref_35","doi-asserted-by":"crossref","first-page":"589","DOI":"10.1093\/bioinformatics\/btp698","article-title":"Fast and accurate long-read alignment with Burrows-Wheeler transform","volume":"26","author":"Li","year":"2010","journal-title":"Bioinformatics"},{"key":"ref_36","unstructured":"Picard (2021, February 19). A Set of Command Line Tools (in Java) for Manipulating High-Throughput Sequencing (HTS) Data and Formats Such as SAM\/BAM\/CRAM and VCF. Available online: http:\/\/broadinstitute.github.io\/picard\/."},{"key":"ref_37","doi-asserted-by":"crossref","first-page":"2078","DOI":"10.1093\/bioinformatics\/btp352","article-title":"1000 Genome Project Data Processing Subgroup. The Sequence Alignment\/Map format and SAMtools","volume":"25","author":"Li","year":"2009","journal-title":"Bioinformatics"},{"key":"ref_38","doi-asserted-by":"crossref","first-page":"491","DOI":"10.1038\/ng.806","article-title":"A framework for variation discovery and genotyping using next-generation DNA sequencing data","volume":"43","author":"DePristo","year":"2011","journal-title":"Nat. Genet."},{"key":"ref_39","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1200\/PO.17.00011","article-title":"OncoKB: A Precision Oncology Knowledge Base","volume":"1","author":"Chakravarty","year":"2017","journal-title":"JCO Precis. Oncol."},{"key":"ref_40","unstructured":"(2021, February 19). Proposal Concerning the Information Transmission Process in Genomic Medicine. Available online: https:\/\/www.amed.go.jp\/en\/news\/seika\/20200706.html."}],"container-title":["Cancers"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/2072-6694\/13\/5\/1121\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,11]],"date-time":"2025-10-11T05:33:37Z","timestamp":1760160817000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/2072-6694\/13\/5\/1121"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,3,5]]},"references-count":40,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2021,3]]}},"alternative-id":["cancers13051121"],"URL":"https:\/\/doi.org\/10.3390\/cancers13051121","relation":{},"ISSN":["2072-6694"],"issn-type":[{"value":"2072-6694","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,3,5]]}}}