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A randomised, double blind, placebo controlled study of celecoxib, a selective cyclooxygenase 2 inhibitor, on duodenal polyposis in familial adenomatous polyposis
  1. R K S Phillips1,,
  2. M H Wallace1,,
  3. P M Lynch2,
  4. E Hawk2,
  5. G B Gordon3,
  6. B P Saunders4,
  7. N Wakabayashi2,
  8. Y Shen2,
  9. S Zimmerman2,
  10. L Godio3,
  11. M Rodrigues-Bigas5,
  12. L-K Su2,
  13. J Sherman3,
  14. G Kelloff6,
  15. B Levin2,
  16. G Steinbach2,
  17. The Fap Study Group7
  1. 1Colorectal Cancer Unit, Imperial Cancer Research Fund, London, UK and St Mark's Hospital, Northwick Park, Harrow HA1 3UJ, UK
  2. 2University of Texas, MD Anderson Cancer Center, Houston, Texas 77030, USA
  3. 3Chemoprevention, Searle, 4901, Searle Parkway, Skokie, Illinois 60077, USA
  4. 4St Mark's Hospital, Northwick Park, Harrow HA1 3UJ, UK
  5. 5Roswell Park Cancer Institute, Lower Gastrointestinal Department, Surgical Oncology, Division Elm and Carlton Streets, Buffalo, New York 14263, USA
  6. 6National Cancer Institute, Chemoprevention Branch, 6130 Executive Boulevard, Bethesda, Maryland 2089, USA
  7. 7FAP Study Group: J Abbruzzese, R Dubois jr, T Fujimura, W Hittleman, S Jester, K King, S Patterson, M Schumacher. FAP Study Group affiliations: University of Texas, MD Anderson Cancer Center, Houston, TX, USA (JA, WH, SP); Vanderbilt University Medical Center, Nashville, TN, USA (RD); GD Searle and Co, Skokie, IL, USA (SJ, KK); National Cancer Institute, Bethesda, MD, USA (MS).
  1. Correspondence to:
    Professor R K S Phillips, St Mark's Hospital, Northwick Park, Watford Road, Harrow HA1 3UJ, UK


Background: Non-selective cyclooxygenase (COX) inhibitors (non-steroidal anti-inflammatory drugs) inhibit large bowel carcinogenesis in patients with familial adenomatous polyposis (FAP). Their role in the duodenum of these patients is less certain. The disease modifying activity of specific COX-2 inhibitors has not been explored in humans.

Patients and methods: This was a randomised, double blind, placebo controlled study of celecoxib (100 mg twice daily (n=34) or 400 mg twice daily (n=32)) versus placebo (n=17), given orally twice daily for six months to patients with FAP. Efficacy was assessed qualitatively by blinded review of shuffled endoscopy videotapes comparing the extent of duodenal polyposis at entry and at six months and quantitatively by measurement of the percentage change in duodenal area covered by discrete and plaque-like adenomas from photographs of high and low density polyposis.

Results: Shuffled and blinded video review showed a statistically significant effect of 400 mg twice daily celecoxib compared with placebo treatment (p=0.033) with all five independent observers scoring a beneficial effect. Overall, patients taking celecoxib 400 mg twice daily showed a 14.5% reduction in involved areas compared with a 1.4% for placebo (p=0.436). However, patients with clinically significant disease at baseline (greater than 5% covered by polyps) showed a 31% reduction in involved areas with celecoxib 400 mg twice daily compared with 8% on placebo (p=0.049).

Conclusions: A panel of five endoscopists found a significant reduction in duodenal polyposis after six months of treatment with celecoxib 400 mg twice daily. COX-2 inhibition may help this otherwise untreatable condition.

  • familial adenomatous polyposis
  • celecoxib
  • cyclooxygenase 2
  • polyposis
  • FAP, familial adenomatous polyposis
  • NSAIDs, non-steroidal anti-inflammatory drugs
  • COX, cyclooxygenase

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