Does a selective cyclooxygenase-2 inhibitor (tiracoxib) induce clinically sufficient suppression of adenomas in patients with familial adenomatous polyposis? A randomized double-blind placebo-controlled clinical trial

International Journal of Clinical Oncology

Volumn 11, Issue 2, 2006, Pages 133-139

  Iwama, Takeo ^a   Akasu, Takayuki ^b   Utsunomiya, Joji ^c   Muto, Tetsuichiro ^d  

^a SASAKI INSTITUTE   (Japan)

^b NATIONAL CANCER CENTER HOSPITAL   (Japan)

^c CANCER INSTITUTE   (Japan)

^d CANCER INSTITUTE HOSPITAL   (Japan)

Author keywords

Chemoprevention of adenoma; Colorectal adenomas; Cyclooxygenase 2 inhibitor; Familial adenomatous polyposis; Nonsteroidal anti inflammatory drugs

Indexed keywords

CREATINE KINASE; CYCLOOXYGENASE 2 INHIBITOR; PLACEBO; TILMACOXIB; TIRACOXIB; UNCLASSIFIED DRUG;

ABNORMALLY HIGH SUBSTRATE CONCENTRATION IN BLOOD; ABNORMALLY LOW SUBSTRATE CONCENTRATION IN BLOOD; ADENOMA; ADENOMATOUS POLYP; ADULT; ARTICLE; CLINICAL TRIAL; COLONOSCOPY; COLORECTAL ADENOMA; COMMON COLD; COMMON COLD SYMPTOM; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFECT; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GASTROINTESTINAL ENDOSCOPY; HEADACHE; HEMOGLOBIN BLOOD LEVEL; HUMAN; MAJOR CLINICAL STUDY; MALE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STOMACH PAIN; STOMATITIS; TUMOR LOCALIZATION; TUMOR VOLUME;

ADENOMATOUS POLYPOSIS COLI; ADULT; COLONIC POLYPS; CYCLOOXYGENASE 2 INHIBITORS; DISEASE PROGRESSION; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; ORGANIC CHEMICALS;

EID: 33645894708     PISSN: 13419625     EISSN: None     Source Type: Journal    
DOI: 10.1007/s10147-005-0548-z     Document Type: Article

References (28)

1. SJ Winawer AG Zauber MN Ho 1993 Prevention of colorectal cancer by colonoscopic polypectomy N Engl J Med 329 1977 1981
2. F Citarda G Tomaselli R Capocaccia 2001 Efficacy in standard clinical practice of colonoscopic polypectomy in reducing colorectal cancer incidence Gut 48 812 815
3. SM Powell N Zilz Y Beazer-Barclay 1992 APC mutations occur early during colorectal tumorigenesis Nature 359 235 237
4. M Miyaki M Konishi R Kikuchi-Yanoshita 1994 Characteristic of somatic mutation of the adenomatous polyposis coli gene in colorectal tumors Cancer Res 54 3011 3020
5. M Pollard PH Luckert 1980 Indomethacin treatment of rats with dimethylhydrazine-induced intestinal tumors Cancer Treat Rep 64 1323 1327
6. T Narisawa M Satoh M Sano 1983 Inhibition of initiation and promotion by N-methylnitrosourea-induced colon carcinogenesis in rats by non-steroid anti-inflammatory agent indomethacin Carcinogenesis 4 1225 1227
7. Δ716 knockout mice by inhibition of cyclooxygenase-2 (COX-2) Cell 87 803 809
8. NN Mahmoud SK Boolbol AJ Dannenberg 1998 The sulfide metabolite of sulindac prevents tumors and restores enterocyte apoptosis in a murine model of familial adenomatous polyposis Carcinogenesis 19 87 91
9. WR Waddell RW Loughry 1983 Sulindac for polyposis of the colon J Surg Oncol 24 83 87
10. M Cruz-Correa LM Hylind KE Romans 2002 Long-term treatment with sulindac in familial adenomatous polyposis: a prospective cohort study Gastroenterology 122 641 645
11. N Matsuhashi A Nakajima Y Fukushima 1997 Effects of sulindac on sporadic colorectal adenomatous polyps Gut 40 344 349
12. M Esaki T Matsumoto M Mizuno Y Kobori 2002 Effect of sulindac treatment for attenuated familial adenomatous polyposis with a new germline APC mutation at codon 161: report of a case Dis Colon Rectum 45 1397 1402
13. RS Sandler S Halabi JA Baron 2003 A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer New Engl J Med 348 883 890
14. R Benamouzig J Deyra A Martin 2003 Daily soluble aspirin and prevention of colorectal adenoma recurrence: 1-year results of the APACC trial Gastroenterology 125 328 336
15. T Takayama S Katsuki Y Takahashi 1998 Aberrant crypt foci of the colon as precursors of adenoma and cancer New Engl J Med 339 1277 1284
16. MJ Thun MM Namboodiri CW Heath 1991 Aspirin use and reduced risk of fatal colon cancer N Engl J Med 325 1593 1596
17. G Steinbach PM Lynch RKS Phillips 2000 The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis New Engl J Med 342 1946 1952
18. T Higuchi T Iwama K Yoshinaga 2003 A randomized, double-blind, placebo-controlled trial of the effects of rofecoxib, a selective cyclooxygenase-2 inhibitor, on rectal polyps in familial adenomatous polyposis patients Clin Cancer Res 9 4756 4760
19. K Wakitani T Nanayama M Masaki 1998 Profile of JTE-522 as a human cyclooxygenase-2 inhibitor Jpn J Pharmacol 78 365 371
20. Δ474 by a novel COX-2 inhibitor, JTE-522 Carcinogenesis 21 953 958
21. Japanese Society for Cancer of the Colon and Rectum 1988 General rules for clinical and pathological studies on cancer of the colon, rectum and anus (in Japanese) 6th ed. Kanehara Tokyo 64
22. SW Fenwick GJ Toogood PA Lodge 2003 The effect of the selective cyclooxygenase-2 inhibitor rofecoxib on human colorectal cancer liver metastases Gastroenterology 125 716 729
23. S Seseko K Umemura M Nakashima 2003 Pharmacokinetics and safety of JTE-522 in Japanese healthy male and female volunteers (in Japanese) Jpn J Clin Pharmacol Ther 34 201 202S
24. J Ladenheim G Garcia D Titzer 1995 Effect of sulindac on sporadic colonic polyps Gastroenterology 108 1083 1087
25. FM Giardiello VW Yang LM Hylind 2002 Primary chemoprevention of familial adenomatous polyposis with sulindac New Engl J Med 346 1054 1059
26. JA Baron BF Cole RS Sandler 2003 A randomized trial of aspirin to prevent colorectal adenomas N Engl J Med 348 891 899
27. S Suleiman DK Rex A Sonnenberg 2002 Chemoprevention of colorectal cancer by aspirin: a cost-effectiveness analysis Gastroenterology 122 78 87
28. T Bodenheimer 2000 Uneasy alliance-clinical investigators and the pharmaceutical industry N Engl J Med 342 1539 154