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Serious adverse event (<jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>) reports of renal cysts from a safety database of 1375 patients from four clinical trials were reviewed. A blinded, retrospective, independent radiologic review (<jats:styled-content style=\"fixed-case\">IRR<\/jats:styled-content>) was performed using scans from patients on study for \u22656\u00a0months in three clinical trials; risk factors for renal cyst development were assessed. Among 17 patients with renal cysts reported as <jats:styled-content style=\"fixed-case\">SAE<\/jats:styled-content>s, evidence of invasion into adjacent structures was noted in seven patients, with no evidence of malignancy found. These patients generally did not require dose reductions, none required permanent crizotinib discontinuation due to this <jats:styled-content style=\"fixed-case\">AE<\/jats:styled-content>, and most continued treatment with clinical benefit. In the blinded <jats:styled-content style=\"fixed-case\">IRR<\/jats:styled-content>, among 255 crizotinib\u2010treated patients, 22%, 3%, and 2% had preexisting simple cysts, complex cysts, or both, respectively. At the 6\u2010month tumor assessment, 9% of all patients had acquired new cysts, and 2% of patients with preexisting cysts had developed new cysts and enlargements (&gt;50%) of preexisting simple cysts. Asians appeared to have an increased risk of developing new cysts on treatment; Koreans in particular had 5.18 times higher odds of developing cysts than non\u2010Asians (95% confidence interval, 1.51\u201317.78; <jats:italic>P\u00a0<\/jats:italic>=<jats:italic>\u00a0<\/jats:italic>0.05). Crizotinib treatment appears to be associated with an increased risk of development and progression of renal cysts in patients with <jats:italic><jats:styled-content style=\"fixed-case\">ALK<\/jats:styled-content><\/jats:italic>\u2010positive <jats:styled-content style=\"fixed-case\">NSCLC<\/jats:styled-content>. While close monitoring is recommended, dosing modification was not generally necessary, allowing patients to remain on crizotinib treatment.<\/jats:p>","DOI":"10.1002\/cam4.437","type":"journal-article","created":{"date-parts":[[2015,3,10]],"date-time":"2015-03-10T10:53:36Z","timestamp":1425984816000},"page":"887-896","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":56,"title":["Complex renal cysts associated with crizotinib treatment"],"prefix":"10.1002","volume":"4","author":[{"given":"Patrick","family":"Schnell","sequence":"first","affiliation":[{"name":"Pfizer Oncology New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Cynthia H.","family":"Bartlett","sequence":"additional","affiliation":[{"name":"Pfizer Oncology New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin J.","family":"Solomon","sequence":"additional","affiliation":[{"name":"Peter MacCallum Cancer Centre Melbourne Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vanessa","family":"Tassell","sequence":"additional","affiliation":[{"name":"Pfizer Oncology La Jolla California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alice T.","family":"Shaw","sequence":"additional","affiliation":[{"name":"Massachusetts General Hospital Boston Massachusetts"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tommaso","family":"de Pas","sequence":"additional","affiliation":[{"name":"European Institute of Oncology Milan Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soo\u2010Hyun","family":"Lee","sequence":"additional","affiliation":[{"name":"National Cancer Center Goyang Gyeonggi Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Geon Kook","family":"Lee","sequence":"additional","affiliation":[{"name":"National Cancer Center Goyang Gyeonggi Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kaoru","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Kinki University Faculty of Medicine Osaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Weiwei","family":"Tan","sequence":"additional","affiliation":[{"name":"Pfizer Oncology La Jolla California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yiyun","family":"Tang","sequence":"additional","affiliation":[{"name":"Pfizer Oncology La Jolla California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Keith D.","family":"Wilner","sequence":"additional","affiliation":[{"name":"Pfizer Oncology La Jolla California"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Allan","family":"Safferman","sequence":"additional","affiliation":[{"name":"Pfizer Oncology New York New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ji\u2010Youn","family":"Han","sequence":"additional","affiliation":[{"name":"National Cancer Center Goyang Gyeonggi Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2015,3,10]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.MCT-07-0365"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1158\/0008-5472.CAN-06-4443"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cell.2007.11.025"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/nature05945"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.4155\/cli.11.92"},{"issue":"9","key":"e_1_2_7_7_1","doi-asserted-by":"crossref","first-page":"ix73","DOI":"10.1093\/annonc\/mds391","article-title":"Prevalence and clinical outcomes for patients with ALK\u00a0gene rearrangement in Europe: preliminary results from the European thoracic oncology platform Lungscape project","volume":"23","author":"Blackhall F.","year":"2012","journal-title":"Ann. 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