{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,16]],"date-time":"2026-07-16T03:27:51Z","timestamp":1784172471648,"version":"3.55.0"},"reference-count":23,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2019,5,23]],"date-time":"2019-05-23T00:00:00Z","timestamp":1558569600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002491","name":"Bristol-Myers Squibb","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100002491","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2019,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The immune checkpoint inhibitor nivolumab inhibits the programmed death 1 receptor and suppresses the immune resistance of cancer cells. This is a long\u2010term follow up of a single\u2010arm, open\u2010label, multicenter, phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> study of nivolumab in untreated Japanese patients with stage <jats:styled-content style=\"fixed-case\">III<\/jats:styled-content>\/<jats:styled-content style=\"fixed-case\">IV<\/jats:styled-content> or recurrent melanoma. In addition, a post\u2013hoc subgroup analysis stratified by melanoma types was performed. Nivolumab was administered intravenously at a dose of 3\u00a0mg\/kg every 2\u00a0weeks. The primary endpoint was the overall response rate (<jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content>), and secondary endpoints included overall survival (<jats:styled-content style=\"fixed-case\">OS<\/jats:styled-content>), progression\u2010free survival (<jats:styled-content style=\"fixed-case\">PFS<\/jats:styled-content>), best overall response, the disease control rate and change in tumor diameter. Safety was assessed by recording treatment\u2010related adverse events (<jats:styled-content style=\"fixed-case\">TRAE<\/jats:styled-content>), including select immune\u2010related adverse events. Of the 24 patients initially included in the primary phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> study, 10 survived for over 3\u00a0years (41.7%). The <jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content> was 34.8% (90% confidence interval [<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>]: 20.8, 51.9) for all patients. When analyzing by melanoma type, the <jats:styled-content style=\"fixed-case\">ORR<\/jats:styled-content> was 66.7% (90% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>: 34.7, 88.3) for superficial spreading, 33.3% (90% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>: 11.7, 65.3) for mucosal, and 28.6% (90% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>: 10.0, 59.1) for acral lentiginous tumors. The median <jats:styled-content style=\"fixed-case\">OS<\/jats:styled-content> was 32.9\u00a0months, the 3\u2010year <jats:styled-content style=\"fixed-case\">OS<\/jats:styled-content> rate was 43.5%, and the 3\u2010year <jats:styled-content style=\"fixed-case\">PFS<\/jats:styled-content> rate was 17.2%. A long\u2010term response was observed in all the tumor types. The most common <jats:styled-content style=\"fixed-case\">TRAE <\/jats:styled-content>included skin toxicity (45.8%) and endocrine disorders (29.2%). This study demonstrated the long\u2010term efficacy and tolerability of nivolumab in patients with advanced or recurrent melanoma, irrespective of melanoma type.<\/jats:p>","DOI":"10.1111\/cas.14015","type":"journal-article","created":{"date-parts":[[2019,4,8]],"date-time":"2019-04-08T23:10:03Z","timestamp":1554765003000},"page":"1995-2003","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Long\u2010term follow up of nivolumab in previously untreated Japanese patients with advanced or recurrent malignant melanoma"],"prefix":"10.1111","volume":"110","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9638-0428","authenticated-orcid":false,"given":"Naoya","family":"Yamazaki","sequence":"first","affiliation":[{"name":"Department of Dermatologic Oncology National Cancer Center Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshio","family":"Kiyohara","sequence":"additional","affiliation":[{"name":"Dermatology Division Shizuoka Cancer Center Hospital Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisashi","family":"Uhara","sequence":"additional","affiliation":[{"name":"Department of Dermatology Shinshu University School of Medicine Nagano Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jiro","family":"Uehara","sequence":"additional","affiliation":[{"name":"Department of Dermatology Asahikawa Medical University Hokkaido Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuhiro","family":"Fujisawa","sequence":"additional","affiliation":[{"name":"Department of Dermatology University of Tsukuba Hospital Ibaraki Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tatsuya","family":"Takenouchi","sequence":"additional","affiliation":[{"name":"Department of Dermatology Niigata Cancer Center Hospital Niigata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaki","family":"Otsuka","sequence":"additional","affiliation":[{"name":"Department of Dermatology Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Uchi","sequence":"additional","affiliation":[{"name":"Department of Dermatology Graduate School of Medical Sciences Kyushu University Fukuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hironobu","family":"Ihn","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Plastic Surgery Faculty of Life Sciences Kumamoto University Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Hatsumichi","sequence":"additional","affiliation":[{"name":"Ono Pharmaceutical Co., Ltd. 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