Abstract
There have been few placebo-controlled randomized double-blind studies of the clinical effects of selective cyclooxygenase-2 (COX-2) inhibitors on the regression of colorectal tumors. This study was designed to examine the regressive effect of a selective COX-2 inhibitor, tiracoxib (JTE-522), on colorectal polyps in patients with familial adenomatous polyposis (FAP), and its safety. Sixty-one patients with FAP diagnosed by Japanese criteria were assigned randomly to receive placebo or JTE-522, at either 150 mg or 200 mg, once daily orally for 26 weeks. Prior to and at the end of the medication period, endoscopy was performed. Adenomas located near an india-ink tattoo injected at the first colonoscopy were identified and measured. The response variables were the percent changes from the baseline in polyp numbers and in specified polyp diameters. Any adverse events that appeared in at least four persons were taken into consideration and compared between the JTE-522 treatment groups and the placebo group. No change in polyp number (median, 0) was observed in any of the three groups. There were no differences between the placebo group and the two treatment groups in the change in polyp size. JTE-522 was well tolerated. Our findings...Continue Reading
References
Sep 17, 1992·Nature·S M PowellK W Kinzler
Dec 15, 1991·The New England Journal of Medicine·M J ThunC W Heath
Oct 1, 1983·Carcinogenesis·T NarisawaT Takahashi
Sep 1, 1983·Journal of Surgical Oncology·W R Waddell, R W Loughry
Apr 1, 1995·Gastroenterology·J LadenheimM B Omary
Dec 30, 1993·The New England Journal of Medicine·S J WinawerJ F Panish
Nov 29, 1996·Cell·M OshimaM M Taketo
Mar 1, 1997·Gut·N MatsuhashiT Oka
Feb 24, 1998·Carcinogenesis·N N MahmoudM M Bertagnolli
Oct 29, 1998·The New England Journal of Medicine·T TakayamaY Niitsu
Dec 30, 1998·Japanese Journal of Pharmacology·K WakitaniM Matsushita
Apr 28, 2000·Carcinogenesis·H SasaiK Wakitani
May 18, 2000·The New England Journal of Medicine·T Bodenheimer
Jun 30, 2000·The New England Journal of Medicine·G SteinbachG Kelloff
May 19, 2001·Gut·F CitardaUNKNOWN Italian Multicentre Study Group
Jan 10, 2002·Gastroenterology·Saud SuleimanAmnon Sonnenberg
Mar 5, 2002·Gastroenterology·Marcia Cruz-CorreaFrancis M Giardiello
Apr 5, 2002·The New England Journal of Medicine·Francis M GiardielloStanley R Hamilton
Oct 24, 2002·Diseases of the Colon and Rectum·Motohiro EsakiMitsuo Iida
Mar 7, 2003·The New England Journal of Medicine·Robert S SandlerRichard Schilsky
Mar 7, 2003·The New England Journal of Medicine·John A BaronRosalind U van Stolk
Aug 2, 2003·Gastroenterology·Robert BenamouzigStanislas Chaussade
Sep 2, 2003·Gastroenterology·Stephen W FenwickMark A Hull
Citations
Jul 2, 2010·Familial Cancer·Kari AlmendingenLars Aabakken
Dec 7, 2013·BMC Surgery·Francesca NolfoAntonio Biondi
Jan 1, 2012·Colorectal Cancer·Christina M LaukaitisEugene W Gerner
Feb 20, 2009·Journal of Gastroenterology·Takeo Iwama
Nov 30, 2011·Best Practice & Research. Clinical Gastroenterology·Brian Kim, Francis M Giardiello
Dec 15, 2015·Best Practice & Research. Clinical Gastroenterology·James Weiquan LiEng Kiong Teo
Dec 13, 2016·Wiley Interdisciplinary Reviews. Systems Biology and Medicine·Lance L Munn
Sep 30, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·José G GuillemUNKNOWN SSO
Jun 6, 2009·The Journal of Clinical Endocrinology and Metabolism·Hadas Stiebel-KalishLeonard Leibovici
Aug 11, 2017·Diseases of the Colon and Rectum·Daniel HerzigScott R Steele
Nov 30, 2019·Gut·Kevin J MonahanUNKNOWN Hereditary CRC guidelines eDelphi consensus group
May 25, 2018·Journal of the Anus, Rectum and Colon·Emiko TakeshitaYoshihisa Saida