Abstract
An apparent causal association between crizotinib treatment and renal cyst development emerged during clinical trials in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC). Serious adverse event (SAE) reports of renal cysts from a safety database of 1375 patients from four clinical trials were reviewed. A blinded, retrospective, independent radiologic review (IRR) was performed using scans from patients on study for ≥ 6 months in three clinical trials; risk factors for renal cyst development were assessed. Among 17 patients with renal cysts reported as SAEs, 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 AE, and most continued treatment with clinical benefit. In the blinded IRR, among 255 crizotinib-treated patients, 22%, 3%, and 2% had preexisting simple cysts, complex cysts, or both, respectively. At the 6-month tumor assessment, 9% of all patients had acquired new cysts, and 2% of patients with preexisting cysts had developed new cysts and enlargements (>50%) of preexisting simple cysts. Asians appeared to have an i...Continue Reading
References
Sep 17, 1994·Lancet·S HorieK Kawabe
Feb 1, 1997·Radiology·A J DavidsonB J Wagner
Jul 31, 2003·Clinical Radiology·Z I Carrim, J T Murchison
May 6, 2004·The Journal of Urology·Ryuichiro KondaTomoaki Fujioka
Sep 6, 2005·Urology·Gary M Israel, Morton A Bosniak
Dec 7, 2006·Radiologic Clinics of North America·Therese M Weber
May 8, 2007·Cancer Research·Helen Y ZouJames G Christensen
Jul 13, 2007·Nature·Manabu SodaHiroyuki Mano
Oct 10, 2007·BJU International·Ashraf A Mosharafa
Dec 18, 2007·Cell·Klarisa RikovaMichael J Comb
Dec 20, 2007·Molecular Cancer Therapeutics·James G ChristensenGerrit Los
Mar 11, 2008·Radiologic Clinics of North America·Srinivasa R PrasadVenkateswar R Surabhi
Sep 9, 2008·Journal of the American Society of Nephrology : JASN·Garabed Eknoyan
Apr 7, 2010·Canadian Urological Association Journal = Journal De L'Association Des Urologues Du Canada·Thomas F Whelan
Oct 29, 2010·The New England Journal of Medicine·Eunice L KwakA John Iafrate
Dec 1, 2011·Therapeutic Advances in Medical Oncology·J Rafael Sierra, Ming-Sound Tsao
Sep 8, 2012·The Lancet Oncology·D Ross CamidgeAlice T Shaw
Oct 19, 2012·Oncology·Nicolas PécuchetStéphane Oudard
Jun 4, 2013·The New England Journal of Medicine·Alice T ShawPasi A Jänne
Aug 7, 2014·The Oncologist·Samuel J KlempnerSai-Hong Ignatius Ou
Dec 2, 2014·Journal of Thoracic Oncology : Official Publication of the International Association for the Study of Lung Cancer·Yen-Ting LinPan-Chyr Yang
Dec 4, 2014·The New England Journal of Medicine·Benjamin J SolomonUNKNOWN PROFILE 1014 Investigators
Citations
Mar 10, 2016·Journal of Hematology & Oncology·Jingjing WuDelong Liu
Apr 30, 2015·Targeted Oncology·Anum AbbasKetki Tendulkar
Jul 15, 2015·Insights Into Imaging·Jemianne Bautista JiaScott C Goodwin
Sep 7, 2016·Radiology Case Reports·Wan Ying ChanJin Wei Kwek
Jul 30, 2016·Investigational New Drugs·Hassan IzzedineMark A Perazella
Jan 18, 2017·Korean Journal of Radiology : Official Journal of the Korean Radiological Society·Ailbhe C O'NeillNikhil H Ramaiya
Aug 11, 2017·Internal Medicine·Kageaki TaimaSadatomo Tasaka
Aug 2, 2019·Current Opinion in Infectious Diseases·Sibylle C MellinghoffOliver A Cornely
Jul 13, 2016·Advances in Anatomic Pathology·Megan L TroxellNeeraja Kambham
Dec 7, 2017·ESMO Open·Fiona BlackhallDong-Wan Kim
Mar 28, 2020·International Medical Case Reports Journal·Pietro Di MarinoMichele De Tursi
Feb 18, 2017·Cancer Imaging : the Official Publication of the International Cancer Imaging Society·Laird B CameronBimal Kumar Parameswaran
Sep 28, 2018·International Journal of Molecular Sciences·Taro YasumaOsamu Hataji
Sep 4, 2020·Urology·Alexei KopelevichHeidi A Stephany
Apr 18, 2021·Cancer Treatment and Research Communications·Ling YangXiaomin Niu
Jun 18, 2021·Clinical Case Reports·Nathaniel E WiestRami Manochakian
Jul 9, 2021·Kidney Research and Clinical Practice·Min Hee Hong