{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,5,14]],"date-time":"2025-05-14T00:31:56Z","timestamp":1747182716688,"version":"3.40.5"},"reference-count":33,"publisher":"Wiley","issue":"29","license":[{"start":{"date-parts":[[2023,8,23]],"date-time":"2023-08-23T00:00:00Z","timestamp":1692748800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009954","name":"Taiho Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009954","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Thoracic Cancer"],"published-print":{"date-parts":[[2023,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>This study evaluated the efficacy and safety of the combination chemotherapy of docetaxel plus S\u20101 in patients with previously treated non\u2010small cell lung cancer (NSCLC) compared to docetaxel alone.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients with previously treated NSCLC were randomly assigned to docetaxel alone (arm A) or a combination of docetaxel and S\u20101 (arm B) for a maximum of four cycles. The primary endpoint was overall survival (OS).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The study was terminated early because of poor accrual. The number of patients evaluated were 74 and 77 in arm A and arm B, respectively. The median OS was 9.8\u2009months (95% confidence interval [CI]: 6.8\u201315.2) and 12.3\u2009months (95% CI: 9.2\u201314.5) in arms A and B, respectively. In arms A and B, the median progression\u2010free survival was 3.5\u2009months (95% CI: 2.7\u20134.0) and 4.1\u2009months (95% CI: 3.2\u20134.7), respectively. No statistically significant difference was observed in OS (hazard ratio [HR]: 0.984, 95% CI: 0.682\u20131.419, <jats:italic>p<\/jats:italic>\u2009=\u20090.4569) or progression\u2010free survival (HR: 0.823, 95% CI: 0.528\u20131.282, <jats:italic>p<\/jats:italic>\u2009=\u20090.0953). The major toxicity was myelosuppression. The incidence of grade 3 or more neutropenia was higher in arm A than in arm B (44.6% vs. 35.1%). However, the incidence of grade 3 or more febrile neutropenia and infection with neutropenia (12.2% vs. 22.1%) was more frequently observed in arm B.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The prematurely terminated study did not show the benefit of two cytotoxic agents over single\u2010agent therapy for previously treated NSCLC patients.<\/jats:p><\/jats:sec>","DOI":"10.1111\/1759-7714.15080","type":"journal-article","created":{"date-parts":[[2023,8,23]],"date-time":"2023-08-23T03:50:44Z","timestamp":1692762644000},"page":"2941-2949","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["A randomized phase <scp>III<\/scp> study of docetaxel alone versus docetaxel plus S\u20101 in patients with previously treated non\u2010small cell lung cancer: <scp>JMTO LC09<\/scp>\u201001"],"prefix":"10.1111","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1876-7069","authenticated-orcid":false,"given":"Shinji","family":"Atagi","sequence":"first","affiliation":[{"name":"Health Management Center Japan Community Health care Organization Yamatokoriyama Hospital  Yamatokoriyama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Daimon","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Hyogo College of Medicine  Nishinomiya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyoichi","family":"Okishio","sequence":"additional","affiliation":[{"name":"Department of Clinical Research Center National Hospital Organization Kinki\u2010Chuo Chest Medical Center  Sakai Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kiyoshi","family":"Komuta","sequence":"additional","affiliation":[{"name":"Internal Medicine Osaka Anti\u2010Tuberculosis Association Osaka Fukujuji Hospital  Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshio","family":"Okano","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine National Hospital Organization Kochi Hospital  Kochi Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koichi","family":"Minato","sequence":"additional","affiliation":[{"name":"Division of Respiratory Medicine Gunma Prefectural Cancer Center  Ota Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Young Hak","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Graduate School of Medicine, Kyoto University  Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryo","family":"Usui","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Tokyo Metropolitan Bokutoh Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chiharu","family":"Tabata","sequence":"additional","affiliation":[{"name":"Cancer Center Hyogo College of Medicine  Nishinomiya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atsuhisa","family":"Tamura","sequence":"additional","affiliation":[{"name":"Center for Pulmonary Diseases National Hospital Organization Tokyo National Hospital  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masaaki","family":"Kawahara","sequence":"additional","affiliation":[{"name":"Operations Office The Japan\u2010Multinational Trial Organization  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,8,23]]},"reference":[{"doi-asserted-by":"publisher","key":"e_1_2_10_2_1","DOI":"10.3322\/caac.21660"},{"doi-asserted-by":"publisher","key":"e_1_2_10_3_1","DOI":"10.6004\/jnccn.2021.0013"},{"doi-asserted-by":"publisher","key":"e_1_2_10_4_1","DOI":"10.1056\/NEJMoa1801005"},{"doi-asserted-by":"publisher","key":"e_1_2_10_5_1","DOI":"10.1056\/NEJMoa1810865"},{"doi-asserted-by":"publisher","key":"e_1_2_10_6_1","DOI":"10.1001\/jama.2014.3741"},{"doi-asserted-by":"publisher","key":"e_1_2_10_7_1","DOI":"10.1200\/JCO.2000.18.10.2095"},{"doi-asserted-by":"publisher","key":"e_1_2_10_8_1","DOI":"10.1200\/JCO.2000.18.12.2354"},{"doi-asserted-by":"publisher","key":"e_1_2_10_9_1","DOI":"10.1200\/JCO.2004.08.163"},{"doi-asserted-by":"publisher","key":"e_1_2_10_10_1","DOI":"10.1056\/NEJMoa050753"},{"doi-asserted-by":"publisher","key":"e_1_2_10_11_1","DOI":"10.1016\/S0140-6736(14)60845-X"},{"doi-asserted-by":"publisher","key":"e_1_2_10_12_1","DOI":"10.1056\/NEJMoa1507643"},{"doi-asserted-by":"publisher","key":"e_1_2_10_13_1","DOI":"10.1056\/NEJMoa1504627"},{"doi-asserted-by":"publisher","key":"e_1_2_10_14_1","DOI":"10.1001\/jama.292.4.470"},{"doi-asserted-by":"publisher","key":"e_1_2_10_15_1","DOI":"10.1200\/JCO.2008.17.5844"},{"issue":"17","key":"e_1_2_10_16_1","first-page":"4004","article-title":"Inhibition by oxonic acid of gastrointestinal toxicity of 5\u2010fluorouracil without loss of its antitumor activity in rats","volume":"53","author":"Shirasaka T","year":"1993","journal-title":"Cancer Res"},{"doi-asserted-by":"publisher","key":"e_1_2_10_17_1","DOI":"10.1054\/bjoc.2001.2031"},{"doi-asserted-by":"publisher","key":"e_1_2_10_18_1","DOI":"10.1093\/annonc\/mdx419"},{"doi-asserted-by":"publisher","key":"e_1_2_10_19_1","DOI":"10.1097\/JTO.0b013e318183f8ed"},{"doi-asserted-by":"publisher","key":"e_1_2_10_20_1","DOI":"10.1002\/sim.4780110205"},{"doi-asserted-by":"publisher","key":"e_1_2_10_21_1","DOI":"10.1097\/JTO.0b013e3181e3248e"},{"doi-asserted-by":"publisher","key":"e_1_2_10_22_1","DOI":"10.3389\/fonc.2021.708943"},{"doi-asserted-by":"publisher","key":"e_1_2_10_23_1","DOI":"10.1200\/JCO.2012.46.0444"},{"doi-asserted-by":"publisher","key":"e_1_2_10_24_1","DOI":"10.1016\/j.lungcan.2013.06.022"},{"doi-asserted-by":"publisher","key":"e_1_2_10_25_1","DOI":"10.1016\/j.lungcan.2023.02.002"},{"doi-asserted-by":"publisher","key":"e_1_2_10_26_1","DOI":"10.1016\/j.cllc.2021.12.009"},{"doi-asserted-by":"publisher","key":"e_1_2_10_27_1","DOI":"10.1016\/S1470-2045(13)70586-2"},{"doi-asserted-by":"publisher","key":"e_1_2_10_28_1","DOI":"10.21037\/tlcr-21-197"},{"doi-asserted-by":"publisher","key":"e_1_2_10_29_1","DOI":"10.21037\/tlcr-21-1018"},{"doi-asserted-by":"publisher","key":"e_1_2_10_30_1","DOI":"10.1016\/j.lungcan.2017.07.034"},{"doi-asserted-by":"publisher","key":"e_1_2_10_31_1","DOI":"10.1016\/j.jtho.2017.10.011"},{"doi-asserted-by":"publisher","key":"e_1_2_10_32_1","DOI":"10.1111\/1759-7714.13055"},{"doi-asserted-by":"publisher","key":"e_1_2_10_33_1","DOI":"10.1200\/JCO.22.00912"},{"doi-asserted-by":"publisher","key":"e_1_2_10_34_1","DOI":"10.1016\/j.lungcan.2022.01.023"}],"container-title":["Thoracic Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/1759-7714.15080","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,12]],"date-time":"2023-10-12T19:31:30Z","timestamp":1697139090000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/1759-7714.15080"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,8,23]]},"references-count":33,"journal-issue":{"issue":"29","published-print":{"date-parts":[[2023,10]]}},"alternative-id":["10.1111\/1759-7714.15080"],"URL":"https:\/\/doi.org\/10.1111\/1759-7714.15080","archive":["Portico"],"relation":{},"ISSN":["1759-7706","1759-7714"],"issn-type":[{"type":"print","value":"1759-7706"},{"type":"electronic","value":"1759-7714"}],"subject":[],"published":{"date-parts":[[2023,8,23]]},"assertion":[{"value":"2023-05-30","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-08-05","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-08-23","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}