{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,20]],"date-time":"2026-01-20T07:20:57Z","timestamp":1768893657515,"version":"3.49.0"},"reference-count":35,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2017,6,15]],"date-time":"2017-06-15T00:00:00Z","timestamp":1497484800000},"content-version":"vor","delay-in-days":14,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013170","name":"Ono Pharmaceutical Co. Ltd","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100013170","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2017,6]]},"abstract":"<jats:p>Treating advanced or recurrent melanoma remains a challenge. Cancer cells can evade the immune system by blocking T\u2010cell activation through overexpression of the inhibitory receptor programmed death 1 (<jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content>\u20101) ligands. The <jats:styled-content style=\"fixed-case\">PD<\/jats:styled-content>\u20101 inhibitor nivolumab blocks the inhibitory signal in T cells, thus overcoming the immune resistance of cancer cells. Nivolumab has shown promising anticancer activity in various cancers. We carried out a single\u2010arm, open\u2010label, multicenter, phase <jats:styled-content style=\"fixed-case\">II<\/jats:styled-content> study to investigate the efficacy and safety of nivolumab in previously untreated Japanese patients with advanced melanoma. Twenty\u2010four 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 were enrolled and received i.v. nivolumab 3 mg\/kg every 2 weeks until disease progression or unacceptable toxicity. The primary endpoint was overall response rate evaluated by an independent radiology review committee. The independent radiology review committee\u2010assessed overall response rate was 34.8% (90% confidence interval, 20.8\u201351.9), and the overall survival rate at 18 months was 56.5% (90% confidence interval, 38.0\u201371.4). Treatment\u2010related adverse events (<jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s) of grade 3 or 4 only occurred in three patients (12.5%). Two patients discontinued nivolumab because of <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s, but all <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s were considered manageable by early diagnosis and appropriate treatment. Subgroup analyses showed that nivolumab was clinically beneficial and tolerable regardless of <jats:italic><jats:styled-content style=\"fixed-case\">BRAF<\/jats:styled-content><\/jats:italic> genotype, and that patients with treatment\u2010related select <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>s and with vitiligo showed tendency for better survival. In conclusion, nivolumab showed favorable efficacy and safety profiles in Japanese patients with advanced or recurrent melanoma, with or without <jats:italic><jats:styled-content style=\"fixed-case\">BRAF<\/jats:styled-content><\/jats:italic> mutations. (Trial registration no. Japic<jats:styled-content style=\"fixed-case\">CTI<\/jats:styled-content>\u2010142533.)<\/jats:p>","DOI":"10.1111\/cas.13241","type":"journal-article","created":{"date-parts":[[2017,3,25]],"date-time":"2017-03-25T10:25:01Z","timestamp":1490437501000},"page":"1223-1230","source":"Crossref","is-referenced-by-count":67,"title":["Efficacy and safety of nivolumab in Japanese patients with previously untreated advanced melanoma: A phase <scp>II<\/scp> study"],"prefix":"10.1111","volume":"108","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":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yoshio","family":"Kiyohara","sequence":"additional","affiliation":[{"name":"Dermatology Division Shizuoka Cancer Center Hospital Shizuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hisashi","family":"Uhara","sequence":"additional","affiliation":[{"name":"Department of Dermatology Shinshu University School of Medicine Nagano Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jiro","family":"Uehara","sequence":"additional","affiliation":[{"name":"Department of Dermatology Asahikawa Medical University Hokkaido Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manabu","family":"Fujimoto","sequence":"additional","affiliation":[{"name":"Department of Dermatology University of Tsukuba Hospital Ibaraki Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatsuya","family":"Takenouchi","sequence":"additional","affiliation":[{"name":"Department of Dermatology Niigata Cancer Center Hospital Niigata Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masaki","family":"Otsuka","sequence":"additional","affiliation":[{"name":"Department of Dermatology Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences Okayama Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hiroshi","family":"Uchi","sequence":"additional","affiliation":[{"name":"Department of Dermatology Graduate School of Medical Sciences Kyushu University Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hironobu","family":"Ihn","sequence":"additional","affiliation":[{"name":"Department of Dermatology and Plastic Surgery Faculty of Life Sciences Kumamoto University Kumamoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hironobu","family":"Minami","sequence":"additional","affiliation":[{"name":"Department Medical Oncology\/Hematology Kobe University Graduate School of Medicine Hyogo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,6,15]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2004.04.165"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2000.18.1.158"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2001.19.16.3635"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.23.4799"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1084\/jem.192.7.1027"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrc3239"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/j.1460-2075.1992.tb05481.x"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/nm730"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/85330"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.24899"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(15)70076-8"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1412082"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1504030"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/00000421-198212000-00014"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2008.10.026"},{"issue":"2","key":"e_1_2_8_17_1","first-page":"S868","article-title":"Phase 2 study of nivolumab (Anti\u2010PD\u20101; 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