{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,7]],"date-time":"2026-09-07T21:36:48Z","timestamp":1788817008362,"version":"build-2803163510"},"reference-count":21,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2025,4,11]],"date-time":"2025-04-11T00:00:00Z","timestamp":1744329600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100010795","name":"Chugai Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100010795","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2025,7]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p>The FIRST\u2010Dx study prospectively evaluated the clinical utility of the comprehensive genomic profiling (CGP) test (FoundationOne CDx) in the first\u2010line setting for patients with chemotherapy\u2010na\u00efve advanced solid tumors (gastrointestinal, biliary, pancreatic, lung, breast, gynecologic, melanoma) in six hospitals in Japan. Here, we report the results of the 1\u2010year interim analysis of the follow\u2010up study about the clinical benefits provided by the upfront CGP test. The primary endpoint was overall survival (OS), and secondary endpoints were the proportion of patients who actually received molecular\u2010based recommended therapy (MBRT) determined by the molecular tumor board, best overall response rate (ORR) in each line of therapy, and progression\u2010free survival (PFS) ratio (PFS on MBRT\/PFS on the first\u2010line therapy). Data from 172 patients with a median follow\u2010up of 15.1 months (range: 0.1\u201321.5 months) were available. The median OS was not reached. Thirty\u2010nine patients (22.7%) received MBRT during this follow\u2010up period. ORR in first\u2010line therapy was 56.3% in the MBRT group (<jats:italic>n<\/jats:italic> =\u200916) vs. 42.3% in the non\u2010MBRT group (<jats:italic>n<\/jats:italic> =\u2009137), and in the second\u2010line was 26.3% in the MBRT group (<jats:italic>n<\/jats:italic> =\u200919) vs. 17.1% in the non\u2010MBRT group (<jats:italic>n<\/jats:italic> =\u200982). Regarding the PFS ratio of second\u2010line MBRT (<jats:italic>n<\/jats:italic> =\u200912), the median PFS ratio was 1.1, and four patients (33.3%) had a ratio \u2265\u20091.3, indicating that MBRT might be effective in changing the clinical outcome. The findings of this study imply that CGP testing before the standard of care for patients with advanced solid tumors could prove to be a clinically beneficial strategy for guiding subsequent precision anticancer treatments.<\/jats:p><jats:p><jats:bold>Trial Registration:<\/jats:bold> Japan Registry of Clinical Trials (jRCT) ID: jRCT1050220041<\/jats:p>","DOI":"10.1111\/cas.70077","type":"journal-article","created":{"date-parts":[[2025,4,12]],"date-time":"2025-04-12T04:50:47Z","timestamp":1744433447000},"page":"1908-1919","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["First\u2010Line Genomic Profiling in Previously Untreated Advanced Solid Tumors: 1\u2010Year Follow\u2010Up of the <scp>FIRST<\/scp>\u2010Dx Study"],"prefix":"10.1111","volume":"116","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0116-5133","authenticated-orcid":false,"given":"Junichi","family":"Matsubara","sequence":"first","affiliation":[{"name":"Department of Clinical Oncology Kyoto University Hospital  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kumi","family":"Mukai","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology Kyoto University Hospital  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5102-2654","authenticated-orcid":false,"given":"Tomohiro","family":"Kondo","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology Kyoto University Hospital  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Yoshioka","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology Kyoto University Hospital  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3658-4442","authenticated-orcid":false,"given":"Hidenori","family":"Kage","sequence":"additional","affiliation":[{"name":"Department of Clinical Genomics The University of Tokyo Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsutoshi","family":"Oda","sequence":"additional","affiliation":[{"name":"Department of Clinical Genomics The University of Tokyo Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sadakatsu","family":"Ikeda","sequence":"additional","affiliation":[{"name":"Department of Precision Cancer Medicine Tokyo Medical and Dental University Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3155-7576","authenticated-orcid":false,"given":"Hiromichi","family":"Ebi","sequence":"additional","affiliation":[{"name":"Division of Molecular Therapeutics Aichi Cancer Center Research Institute  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kei","family":"Muro","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology Aichi Cancer Center  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinya","family":"Kajiura","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology Toyama University Hospital  Toyama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryuji","family":"Hayashi","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology Toyama University Hospital  Toyama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reiko","family":"Ashida","sequence":"additional","affiliation":[{"name":"Second Department of Internal Medicine Wakayama Medical University  Wakayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masayuki","family":"Kitano","sequence":"additional","affiliation":[{"name":"Second Department of Internal Medicine Wakayama Medical University  Wakayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3127-8203","authenticated-orcid":false,"given":"Manabu","family":"Muto","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology Kyoto University Hospital  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,4,11]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41591\u2010023\u201002379\u20104"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ccell.2020.12.021"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1615014"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1111\/cas.15517"},{"key":"e_1_2_10_6_1","volume-title":"CDRH's Approach to Tumor Profiling Next Generation Sequencing Tests","author":"FDA Fact Sheet","year":"2022"},{"key":"e_1_2_10_7_1","unstructured":"\u201cNext Generation Sequencing (NGS) for Medicare Beneficiaries With Advanced Cancer (CAG\u201000450 N). 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