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Here, we report overall survival and updated efficacy and safety results. Sixty\u2010four Japanese patients with metastatic renal cell carcinoma following prior therapy with cytokines were treated with axitinib at a starting dose of 5\u00a0mg b.i.d. Following median treatment duration of 14.2\u00a0months, median overall survival was 37.3\u00a0months (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>, 28.6\u201349.9). The objective response rate, the primary endpoint of the study, was 51.6% (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>, 38.7\u201364.2); the median duration of response, 11.1\u00a0months (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>, 8.2\u201313.7); and the median progression\u2010free survival was 11.0\u00a0months (95% <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>, 9.2\u201312.0), assessed by the independent review committee. Common treatment\u2010related all\u2010grade adverse events were hypertension (88%), hand\u2010foot syndrome (75%), diarrhea (66%), proteinuria (63%), fatigue (55%) and dysphonia (53%). In an exploratory analysis, median overall survival was found to be significantly longer in patients who had greater decreases in plasma levels of soluble vascular endothelial growth factor receptor\u20102 during the first cycle of treatment. In conclusion, the present study showed axitinib to be effective, and toxicities with long\u2010term treatment were generally controllable with axitinib dose modification and\/or standard medications in these Japanese patients. Some frequently reported adverse events warrant close monitoring and management. Changes in the plasma levels of soluble vascular endothelial growth factor receptor\u20102 may be used as a prognostic factor for overall survival in metastatic renal cell carcinoma following axitinib treatment. This study is registered at <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"http:\/\/ClinicalTrial.gov\">ClinicalTrial.gov<\/jats:ext-link> (identifier <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>00569946).<\/jats:p>","DOI":"10.1111\/cas.12546","type":"journal-article","created":{"date-parts":[[2014,10,6]],"date-time":"2014-10-06T05:12:52Z","timestamp":1412572372000},"page":"1576-1583","source":"Crossref","is-referenced-by-count":25,"title":["Overall survival and final efficacy and safety results from a Japanese phase <scp>II<\/scp> study of axitinib in cytokine\u2010refractory metastatic renal cell carcinoma"],"prefix":"10.1111","volume":"105","author":[{"given":"Masatoshi","family":"Eto","sequence":"first","affiliation":[{"name":"Faculty of Life Sciences Kumamoto University Kumamoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hirotsugu","family":"Uemura","sequence":"additional","affiliation":[{"name":"Kinki University School of Medicine Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihiko","family":"Tomita","sequence":"additional","affiliation":[{"name":"Yamagata University Faculty of Medicine Yamagata Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroomi","family":"Kanayama","sequence":"additional","affiliation":[{"name":"The University of Tokushima Graduate School Tokushima Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nobuo","family":"Shinohara","sequence":"additional","affiliation":[{"name":"Hokkaido University Graduate School of Medicine Hokkaido Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoichi","family":"Kamei","sequence":"additional","affiliation":[{"name":"Pfizer Japan Inc. 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