{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T06:36:37Z","timestamp":1777876597916,"version":"3.51.4"},"reference-count":23,"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 trial. Disease progression and pneumonitis were reported as the main reasons to preclude the initiation of durvalumab in multiple retrospective studies. However, the transition rate and the reasons for failure to proceed to consolidation therapy with durvalumab after CRT were not evaluated prospectively. Although phase II studies in Japan have shown high efficacy and tolerability of CRT with cisplatin\u2009+\u2009S-1 (SP), no prospective study using durvalumab after SP-based CRT has yet been reported. We therefore conducted a phase II study to verify the efficacy and safety of durvalumab following SP-based CRT. In this interim analysis, we report the transition rate and the reasons for its failure.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/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 every 2\u2009weeks for up to 12\u2009months. The primary endpoint was 12\u2009month progression-free survival rate.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>Fifty-nine patients were enrolled, of whom 86.4% (51\/59) proceeded to durvalumab. All of them initiated durvalumab within 42\u2009days after CRT [median 18\u2009days (range: 3\u201338)], including 27.5% (14\/51) in &lt;14\u2009days. Common reasons for failure to proceed to durvalumab were disease progression (2\/59, 3.4%) and adverse events (6\/59, 10.2%). Among the latter cases, four resumed treatment and proceeded to durvalumab within 42\u2009days on off-protocol. The objective response rate and the disease control rate were 62.7% and 93.2%, respectively. The incidences of \u2a7egrade 3 pneumonitis, febrile neutropenia, and esophagitis were 0%, 8.5%, and 3.4%, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>Regarding durvalumab after CRT, this interim analysis of the SAMURAI study clarified the high transition rate, early introduction, and reasons for failure to proceed to consolidation therapy, which were not determined in the PACIFIC trial.<\/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\/17588359221116603","type":"journal-article","created":{"date-parts":[[2022,7,30]],"date-time":"2022-07-30T01:50:58Z","timestamp":1659145858000},"update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":2,"title":["Prospective analysis of factors precluding the initiation of durvalumab from an interim analysis of a phase II trial 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)"],"prefix":"10.1177","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5738-0313","authenticated-orcid":false,"given":"Shigeru","family":"Tanzawa","sequence":"first","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Itabashi-ku, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tomonori","family":"Makiguchi","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Aomori, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sadatomo","family":"Tasaka","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Hirosaki University Graduate School of Medicine, Hirosaki, Aomori, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Megumi","family":"Inaba","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Kumamoto Chuo Hospital, Kumamoto, Kumamoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryosuke","family":"Ochiai","sequence":"additional","affiliation":[{"name":"Division of Medical Oncology, Department of Internal Medicine, Teikyo University School of Medicine, Itabashi-ku, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junya","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koji","family":"Inoue","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Ehime Prefectural Central Hospital, Matsuyama, Ehime, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takayuki","family":"Kishikawa","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Tochigi Cancer Center, Utsunomiya, Tochigi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masanao","family":"Nakashima","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Shin-Yurigaoka General Hospital, Kawasaki, Kanagawa, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keiichi","family":"Fujiwara","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, National Hospital Organization Okayama Medical Center, Okayama, Okayama, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tadashi","family":"Kohyama","sequence":"additional","affiliation":[{"name":"Department of Internal medicine, Teikyo University Mizonokuchi Hospital, Kawasaki, Kanagawa, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroo","family":"Ishida","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama, Kanagawa, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shoichi","family":"Kuyama","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, National Hospital Organization Iwakuni Clinical Center, Iwakuni, Yamaguchi, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naoki","family":"Miyazawa","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Saiseikai Yokohamashi Nanbu Hospital, Yokohama, Kanagawa, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"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":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Miyawaki","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Kagawa Prefectural Central Hospital, Takamatsu, Kagawa, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Naohiro","family":"Oda","sequence":"additional","affiliation":[{"name":"Department of Internal medicine, Fukuyama City Hospital, Fukuyama, Hiroshima, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nobuhisa","family":"Ishikawa","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Hiroshima Prefectural Hospital, Hiroshima, Hiroshima, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ryotaro","family":"Morinaga","sequence":"additional","affiliation":[{"name":"Department of Thoracic Medical Oncology, Oita Prefectural Hospital, Oita, Oita, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kei","family":"Kusaka","sequence":"additional","affiliation":[{"name":"The Center for Pulmonary Diseases, National Hospital Organization Tokyo National Hospital, Kiyose, Tokyo, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yosuke","family":"Miyamoto","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Okayama Rosai Hospital, Okayama, Okayama, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toshihide","family":"Yokoyama","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Okayama, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chiaki","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Chugoku Central Hospital, Fukuyama, Hiroshima, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takeshi","family":"Tsuda","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Toyama Prefectural Central Hospital, Toyama, Toyama, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sunao","family":"Ushijima","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Kumamoto Kenhoku Hospital, Tamana, Kumamoto, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kazuhiko","family":"Shibata","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Kouseiren Takaoka Hospital, Takaoka, Toyama, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takuo","family":"Shibayama","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, National Hospital Organization Okayama Medical Center, Okayama, Okayama, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Akihiro","family":"Bessho","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Japanese Red Cross Okayama Hospital, Okayama, Okayama, Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyoichi","family":"Kaira","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Saitama Medical University International Medical Center, Hidaka, Saitama, 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