{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,26]],"date-time":"2026-08-26T23:16:19Z","timestamp":1787786179417,"version":"build-2784847793"},"reference-count":7,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2022,4,20]],"date-time":"2022-04-20T00:00:00Z","timestamp":1650412800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,4,20]],"date-time":"2022-04-20T00:00:00Z","timestamp":1650412800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb K.K."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Clin Oncol"],"published-print":{"date-parts":[[2022,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>This all-case post-marketing surveillance (PMS) evaluated the real-world safety and effectiveness of nivolumab monotherapy in Japanese patients with un-resectable or metastatic renal cell carcinoma (RCC).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This multicenter, open-label, non-interventional, observational PMS study (registered from August 2016 to January 2017) was conducted in patients who were newly initiated on nivolumab monotherapy. Assessments included treatment-related adverse events (TRAEs) of special interest, patient characteristics affecting safety, and effectiveness over 12\u00a0months.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Overall, 580 patients were enrolled; 555 and 554 patients comprised the safety and effectiveness analysis sets, respectively. The median (range) age of the population was 66\u00a0(14\u201390) years. Nivolumab was initiated as 1st-, 2nd-, and\u2009\u2265\u20093rd-line treatment in 0.2%, 42.0%, and 57.8% of patients, respectively. TRAEs were reported in 275 (49.5%) patients. The most common TRAEs of special interest included thyroid dysfunction (9.5%), hepatic dysfunction (8.6%), and interstitial lung disease (6.7%). The incidence of TRAEs was significantly higher in elderly patients (\u2265\u200965 vs\u2009&lt;\u200965\u00a0years;\u2009\u2265\u200975 vs\u2009&lt;\u200975\u00a0years); patients with lower C-reactive protein levels (&lt;\u20095 vs\u2009\u2265\u20095\u00a0mg\/dL); and patients with vs without a past medical history, including hepatic, thyroid, and autoimmune diseases. The 6- and 12-month survival rates were 71.8% and 57.9%, respectively.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>The safety profile of nivolumab monotherapy in Japanese patients with advanced RCC was similar to that in the phase 3 CheckMate 025 trial. No new safety signals were observed in this study.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10147-022-02155-3","type":"journal-article","created":{"date-parts":[[2022,4,20]],"date-time":"2022-04-20T05:04:36Z","timestamp":1650431076000},"page":"1061-1067","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Real-world safety and effectiveness of nivolumab for advanced renal cell carcinoma in Japan: a post-marketing surveillance"],"prefix":"10.1007","volume":"27","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3665-9523","authenticated-orcid":false,"given":"Hirotsugu","family":"Uemura","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihiko","family":"Tomita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Norio","family":"Nonomura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Yoshizaki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takafumi","family":"Nakao","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuo","family":"Shinohara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,4,20]]},"reference":[{"issue":"19","key":"2155_CR1","doi-asserted-by":"publisher","first-page":"1803","DOI":"10.1056\/NEJMoa1510665","volume":"373","author":"RJ Motzer","year":"2015","unstructured":"Motzer RJ, Escudier B, McDermott DF et al (2015) Nivolumab versus everolimus in advanced renal-cell carcinoma. N Engl J Med 373(19):1803\u20131813","journal-title":"N Engl J Med"},{"issue":"6","key":"2155_CR2","doi-asserted-by":"publisher","first-page":"506","DOI":"10.1093\/jjco\/hyz026","volume":"49","author":"Y Tomita","year":"2019","unstructured":"Tomita Y, Fukasawa S, Shinohara N et al (2019) Nivolumab versus everolimus in advanced renal cell carcinoma: Japanese subgroup 3-year follow-up analysis from the phase III CheckMate 025 study. Jpn J Clin Oncol 49(6):506\u2013514","journal-title":"Jpn J Clin Oncol"},{"key":"2155_CR3","unstructured":"English RA Information Task Force, International Affairs Committee, Japan Pharmaceutical Manufacturers Association. Pharmaceutical administration and regulations in Japan. http:\/\/www.nihs.go.jp\/mhlw\/yakuji\/yakuji-e_20110502-02.pdf. Accessed Jan 2022"},{"issue":"446","key":"2155_CR4","doi-asserted-by":"publisher","first-page":"496","DOI":"10.1080\/01621459.1999.10474144","volume":"94","author":"JP Fine","year":"1999","unstructured":"Fine JP, Gray RJ (1999) A proportional hazards model for the subdistribution of a competing risk. J Am Stat Assoc 94(446):496\u2013509","journal-title":"J Am Stat Assoc"},{"issue":"8","key":"2155_CR5","doi-asserted-by":"publisher","first-page":"1533","DOI":"10.1007\/s10147-020-01692-z","volume":"25","author":"N Hinata","year":"2020","unstructured":"Hinata N, Yonese J, Masui S et al (2020) A multicenter retrospective study of nivolumab monotherapy in previously treated metastatic renal cell carcinoma patients: interim analysis of Japanese real-world data. Int J Clin Oncol 25(8):1533\u20131542","journal-title":"Int J Clin Oncol"},{"issue":"5","key":"2155_CR6","first-page":"405","volume":"50","author":"A Azuma","year":"2007","unstructured":"Azuma A, Kudoh S (2007) High prevalence of drug-induced pneumonia in Japan. JMAJ 50(5):405\u2013411","journal-title":"JMAJ"},{"key":"2155_CR7","unstructured":"Pharmaceuticals and Medical Devices Agency. Review report: nivolumab. https:\/\/www.pmda.go.jp\/english\/review-services\/reviews\/approved-information\/drugs\/0001.html. Accessed Nov 2021."}],"container-title":["International Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10147-022-02155-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10147-022-02155-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10147-022-02155-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,19]],"date-time":"2022-05-19T04:13:38Z","timestamp":1652933618000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10147-022-02155-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,4,20]]},"references-count":7,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2022,6]]}},"alternative-id":["2155"],"URL":"https:\/\/doi.org\/10.1007\/s10147-022-02155-3","relation":{},"ISSN":["1341-9625","1437-7772"],"issn-type":[{"value":"1341-9625","type":"print"},{"value":"1437-7772","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,4,20]]},"assertion":[{"value":"23 November 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"6 March 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"20 April 2022","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Hirotsugu Uemura has served in an advisory role for Ono Pharmaceutical Co., Ltd., Sanofi, and Janssen Pharmaceuticals; received honoraria (e.g., lecture fees) from Bristol Myers Squibb K. K., Bayer, Pfizer Inc., Sanofi, and Janssen Pharmaceuticals; and received research funding from AstraZeneca, The Takeda Pharmaceutical Company Limited, Astellas Pharma Inc., Janssen Pharmaceuticals, Sanofi, Ono Pharmaceutical Co., Ltd., Kissei Pharmaceutical, and Daiichi Sankyo Company. Yoshihiko Tomita received honoraria (e.g., lecture fees) from Astellas Pharma Inc., Bristol Myers Squibb K. K., Novartis, Pfizer Inc., Taiho Pharmaceutical Co., Ltd., The Takeda Pharmaceutical Company Limited, Ono Pharmaceutical Co., Ltd., Terumo Corporation, MSD, and Merck & Co., Inc. and research funding from Astellas Pharma Inc., AstraZeneca, Ono Pharmaceutical Co., Ltd., The Chugai Pharmaceutical Co., Ltd., and The Takeda Pharmaceutical Company Limited. Norio Nonomura received honoraria (e.g., lecture fees) from The Takeda Pharmaceutical Company Limited, Ono Pharmaceutical Co., Ltd., AstraZeneca, and Merck & Co., Inc. and research funding from The Takeda Pharmaceutical Company Limited, Nippon Shinyaku Co. Ltd., and Taiho Pharmaceutical Co., Ltd. Kenji Yoshizaki and Takafumi Nakao are employees of Ono Pharmaceutical Co., Ltd. Nobuo Shinohara received honoraria (e.g., lecture fees) from Pfizer Inc., Ono Pharmaceutical Co., Ltd., Bristol Myers Squibb K. K., Novartis, Astellas Pharma Inc., The Takeda Pharmaceutical Company Limited, and MSD; fees for promotional materials (e.g., manuscript fees) from Ono Pharmaceutical Co., Ltd. and Bristol Myers Squibb K. K.; and research funding from Ono Pharmaceutical Co., Ltd., The Takeda Pharmaceutical Company Limited, and Astellas Pharma Inc.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}