{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T16:52:22Z","timestamp":1783788742351,"version":"3.55.0"},"reference-count":35,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2021,6,11]],"date-time":"2021-06-11T00:00:00Z","timestamp":1623369600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100001009","name":"Bristol-Myers Squibb Foundation","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001009","id-type":"DOI","asserted-by":"publisher"}]},{"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":[],"published-print":{"date-parts":[[2021,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Nivolumab, the anti-programmed cell death protein 1 antibody, has been approved for advanced melanoma, mainly based on evidence from Western countries. The profile of melanoma differs between Caucasian and Asian patients. This study was performed to obtain post-marketing data of nivolumab in Japanese patients with advanced melanoma.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This prospective, observational study involved patients with unresectable or metastatic melanoma treated with nivolumab at dosages of 2\u00a0mg\/kg every 3\u00a0weeks or 3\u00a0mg\/kg every 2\u00a0weeks. The primary endpoints were objective response rate and overall survival. The secondary endpoints were progression-free survival and the objective response rate according to immune-related Response Evaluation Criteria in Solid Tumours.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Result<\/jats:title>\n                  <jats:p>Among 124 patients analysed, mucosal melanoma was the most common subtype, followed by acral lentiginous, nodular, superficial spreading and lentigo maligna melanoma. Response Evaluation Criteria in Solid Tumours evaluation showed an objective response rate of 17.7%. The median survival time was 15.93\u00a0months, and the 1-year overall survival rate was 66%. Outcomes were not significantly different among melanoma subtypes. Better overall survival and\/or progression-free survival but not objective response rate were associated with performance status 0, lower levels of lactate dehydrogenase, C-reactive protein and neutrophil-to-lymphocyte ratio. Patients with immune-related adverse events showed a better objective response rate, 3-month landmark overall survival and progression-free survival than patients without immune-related adverse events.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The objective response rate and median survival time in Japanese patients treated with nivolumab were lower in daily practice than the &amp;gt;30% and\u00a0&amp;gt;30\u00a0months, respectively, seen in global phase III trials. The occurrence of immune-related adverse events may be a predictor for survival and response to treatment with nivolumab.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyab064","type":"journal-article","created":{"date-parts":[[2021,6,4]],"date-time":"2021-06-04T11:37:23Z","timestamp":1622806643000},"page":"1232-1241","source":"Crossref","is-referenced-by-count":20,"title":["Prospective observational study of the efficacy of nivolumab in Japanese patients with advanced melanoma (CREATIVE study)"],"prefix":"10.1093","volume":"51","author":[{"given":"Naoya","family":"Yamazaki","sequence":"first","affiliation":[{"name":"Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, 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":"Yasuhiro","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Department of Skin Oncology\/Dermatology, Saitama Medical University International Medical Center, Saitama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akira","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenjiro","family":"Namikawa","sequence":"additional","affiliation":[{"name":"Department of Dermatologic Oncology, National Cancer Center Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shigehisa","family":"Kitano","sequence":"additional","affiliation":[{"name":"Department of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan"},{"name":"Division of Cancer Immunotherapy Development, Advanced Medical Development Center, The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomonobu","family":"Fujita","sequence":"additional","affiliation":[{"name":"Division of Cellular Signaling, Institute for Advanced Medical Research, Keio University School of Medicine, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazumi","family":"Kubota","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Epidemiology, Yokohama City University School of Medicine, Yokohama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeharu","family":"Yamanaka","sequence":"additional","affiliation":[{"name":"Department of Biostatistics and Epidemiology, Yokohama City University School of Medicine, Yokohama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutaka","family":"Kawakami","sequence":"additional","affiliation":[{"name":"Division of Cellular Signaling, Institute for Advanced Medical Research, Keio University School of Medicine, Tokyo, Japan"},{"name":"Department of Immunology, School of Medicine, International University of Health and Welfare, Chiba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,6,12]]},"reference":[{"key":"2021080204311960500_ref1","article-title":"Global incidence and mortality of skin cancer by histological subtype and its relationship with the human development index (HDI); 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