{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,5]],"date-time":"2026-08-05T11:24:10Z","timestamp":1785929050689,"version":"3.56.0"},"reference-count":20,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,5,2]],"date-time":"2021-05-02T00:00:00Z","timestamp":1619913600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004330","name":"Smoking Research Foundation","doi-asserted-by":"publisher","award":["16K11035"],"award-info":[{"award-number":["16K11035"]}],"id":[{"id":"10.13039\/501100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Reports"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The paradigm of medical treatment for metastatic urothelial carcinoma is dramatically changing through the introduction of pembrolizumab.<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>We investigated the treatment effectiveness, the safety profile, and the prognostic factors of pembrolizumab in Japanese real\u2010world clinical practice.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and results<\/jats:title><jats:p>The medical records of 74 consecutive Japanese patients with metastatic urothelial cancer (UC), who started pembrolizumab as a second\u2010 or later\u2010line treatment at our institution between January 2018 and March 2020, were reviewed and statistically analyzed. The median follow\u2010up period after initiation of pembrolizumab was 8.5 (interquartile range: 3.5\u201315.7) months. The objective response rate was 30.2%, the median progression\u2010free survival period was 4.9\u2009months, and the median overall survival (OS) period was 13.3\u2009months. Evaluation revealed that 39 (52.9%) patients experienced adverse events (AEs), among whom eight patients (10.9%) had severe AEs (grade 3 or more), including grade 5 hemophagocytic syndrome. Multivariate analysis indicated that the presence of liver metastasis, worse performance status (\u22652), elevated serum lactate dehydrogenase, and increased C\u2010reactive protein were predictive of shorter OS.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>We studied the effectiveness and safety profile of pembrolizumab therapy in Japanese UC patients. We believe that the data presented here will be useful for clinical physicians.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cnr2.1398","type":"journal-article","created":{"date-parts":[[2021,5,2]],"date-time":"2021-05-02T08:17:09Z","timestamp":1619943429000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Effectiveness and safety profile of pembrolizumab for metastatic urothelial cancer: A retrospective single\u2010center analysis in Japan"],"prefix":"10.1002","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9454-3345","authenticated-orcid":false,"given":"Motohiro","family":"Fujiwara","sequence":"first","affiliation":[{"name":"Department of Urology Cancer Institute Hospital, Japanese Foundation for Cancer Research  Tokyo 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