{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T12:04:29Z","timestamp":1792757069502,"version":"4.5.0"},"reference-count":28,"publisher":"SAGE Publications","license":[{"start":{"date-parts":[[2022,1,1]],"date-time":"2022-01-01T00:00:00Z","timestamp":1640995200000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004325","name":"astrazeneca","doi-asserted-by":"publisher","award":["ESR-18-14099"],"award-info":[{"award-number":["ESR-18-14099"]}],"id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Ther Adv Med Oncol"],"published-print":{"date-parts":[[2022,1]]},"abstract":"<jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>The standard of care for unresectable, locally advanced non-small-cell lung cancer (LA-NSCLC) is chemoradiotherapy (CRT) followed by durvalumab, based on the PACIFIC study. Although multiple Japanese phase II studies have shown high efficacy and tolerability of CRT with cisplatin plus S-1 (SP), no prospective study using durvalumab after SP-based CRT has been reported.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives:<\/jats:title>\n                    <jats:p>We conducted a multicenter phase II study of this approach, the interim analysis of which showed a high transition rate to durvalumab consolidation therapy. Here, we report the primary analysis results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design:<\/jats:title>\n                    <jats:p>\n                      In treatment-na\u00efve LA-NSCLC, cisplatin (60\u2009mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      , day 1) and S-1 (80\u2013120\u2009mg\/body, days 1\u201314) were administered with two 4-week cycles with concurrent thoracic radiotherapy (60\u2009Gy) followed by durvalumab (10\u2009mg\/kg) every 2\u2009weeks for up to 1\u2009year.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>The primary endpoint was 1-year progression-free survival (PFS). The expected 1-year PFS and its lower limit of the 80% confidence interval (CI) were set as 63% and 47%, respectively, based on the results of TORG1018 study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>In all, 59 patients were enrolled, with 51 (86.4%) proceeding to durvalumab. The objective response rate throughout the study was 72.9% (95% CI: 59.7\u201383.6%). After median follow-up of 21.9\u2009months, neither median PFS nor OS was reached. The 1-year PFS was 72.5% (80% CI: 64.2\u201379.2%, 95% CI: 59.1\u201382.2%), while the 1-year overall survival was 91.5% (95% CI: 80.8\u201396.4%). No grade 5 adverse events were observed throughout the study. The most common adverse event during the consolidation phase was pneumonitis (any grade, 78.4%; grade \u2a7e3, 2.0%). Eventually, 52.5% of patients completed 1-year durvalumab consolidation therapy from CRT initiation.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>This study of durvalumab after SP-based CRT met its primary endpoint and found a 1-year PFS of 73% from CRT initiation. This study provides the first prospective data on the prognosis and tolerability of durvalumab consolidation from the initiation of CRT.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration:<\/jats:title>\n                    <jats:p>Japan Registry of Clinical Trials, jRCTs031190127, registered 1 November, 2019, https:\/\/jrct.niph.go.jp\/latest-detail\/jRCTs031190127<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/17588359221142786","type":"journal-article","created":{"date-parts":[[2022,12,19]],"date-time":"2022-12-19T02:27:10Z","timestamp":1671416830000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":5,"title":["A phase II study of S-1 and cisplatin with concurrent thoracic radiotherapy followed by durvalumab for unresectable, locally advanced non-small-cell lung cancer in Japan (SAMURAI study): primary analysis"],"prefix":"10.1177","volume":"14","author":[{"given":"Hisashi","family":"Tanaka","sequence":"first","affiliation":[{"name":"Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Aomori, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5738-0313","authenticated-orcid":false,"given":"Shigeru","family":"Tanzawa","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Itabashi-ku, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshihiro","family":"Misumi","sequence":"additional","affiliation":[{"name":"Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9249-7904","authenticated-orcid":false,"given":"Tomonori","family":"Makiguchi","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Aomori, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Megumi","family":"Inaba","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Kumamoto Chuo Hospital, Kumamoto, Kumamoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Honda","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Itabashi-ku, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junya","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Inoue","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takayuki","family":"Kishikawa","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masanao","family":"Nakashima","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Shin-Yurigaoka General Hospital, Kawasaki, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiichi","family":"Fujiwara","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, National Hospital Organization Okayama Medical Center, Okayama, Okayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadashi","family":"Kohyama","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Teikyo University Hospital, Mizonokuchi, Kawasaki, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroo","family":"Ishida","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shoichi","family":"Kuyama","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, National Hospital Organization Iwakuni Clinical Center, Iwakuni, Yamaguchi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoki","family":"Miyazawa","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Saiseikai Yokohamashi Nanbu Hospital, Yokohama, Kanagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomomi","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Division of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Saga, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Miyawaki","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naohiro","family":"Oda","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Fukuyama City Hospital, Fukuyama, Hiroshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuhisa","family":"Ishikawa","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Hiroshima Prefectural Hospital, Hiroshima, Hiroshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryotaro","family":"Morinaga","sequence":"additional","affiliation":[{"name":"Department of Thoracic Medical Oncology, Oita Prefectural Hospital, Oita, Oita, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kei","family":"Kusaka","sequence":"additional","affiliation":[{"name":"The Center for Pulmonary Diseases, National Hospital Organization Tokyo National Hospital, Kiyose, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4516-0433","authenticated-orcid":false,"given":"Nobukazu","family":"Fujimoto","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Okayama Rosai Hospital, Okayama, Okayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasushi","family":"Fukuda","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Okayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masayuki","family":"Yasugi","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Hiroshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Tsuda","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Toyama Prefectural Central Hospital, Toyama, Toyama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sunao","family":"Ushijima","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Kumamoto Kenhoku Hospital, Tamana, Kumamoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4864-5970","authenticated-orcid":false,"given":"Kazuhiko","family":"Shibata","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Kouseiren Takaoka Hospital, Takaoka, Toyama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuo","family":"Shibayama","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, National Hospital Organization Okayama Medical Center, Okayama, Okayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0394-7377","authenticated-orcid":false,"given":"Akihiro","family":"Bessho","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Okayama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyoichi","family":"Kaira","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka, Saitama, 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A study of durvalumab as consolidation therapy in non-small cell lung cancer patients (PACIFIC-5), https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03706690?term=pacific-5&draw=2&rank=1 (accessed July 28 2022)."}],"container-title":["Therapeutic Advances in Medical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17588359221142786","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/17588359221142786","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/17588359221142786","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,30]],"date-time":"2026-04-30T22:27:59Z","timestamp":1777588079000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/17588359221142786"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,1]]},"references-count":28,"alternative-id":["10.1177\/17588359221142786"],"URL":"https:\/\/doi.org\/10.1177\/17588359221142786","relation":{},"ISSN":["1758-8359","1758-8359"],"issn-type":[{"value":"1758-8359","type":"print"},{"value":"1758-8359","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,1]]},"article-number":"17588359221142786"}}