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Five-Year Efficacy and Safety Analysis of the Adenoma Prevention with Celecoxib Trial

Lookup NU author(s): Professor Sir John BurnORCiD


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The Adenoma Prevention with Celecoxib Trial examined the efficacy and safety of the cyclooxygenase (Cox)-2 inhibitor, celecoxib, for sporadic colorectal adenoma prevention in patients at high risk for colorectal cancer. The trial randomized 2,035 subjects to receive either placebo, celecoxib 200 mg twice daily, or celecoxib 400 mg twice daily. The primary study safety and efficacy analyses involved 3 years of treatment. The results showed significant antitumor effect but also indicated increased cardiovascular adverse events in patients treated with celecoxib compared with placebo. A total of 933 patients participated in an extension of the Adenoma Prevention with Celecoxib Trial, with a planned total treatment and surveillance duration of 5 years. Study medication was stopped early, resulting in a median treatment duration of 3.1 years for those with a year 5 colonoscopy. Patients treated on the placebo arm had a cumulative adenoma incidence of 68.4% over 5 years of observation. This figure was 59.0% (P

Publication metadata

Author(s): Bertagnolli MM, Eagle CJ, Zauber AG, Redston M, Breazna A, Kim K, Tang J, Rosenstein RB, Umar A, Bagheri D, Collins NT, Burn J, Chung DC, Dewar T, Foley TR, Hoffman N, Macrae F, Pruitt RE, Saltzman JR, Salzberg B, Sylwestrowicz T, Hawk ET, Adenoma Prevention Celecoxib Study

Publication type: Article

Publication status: Published

Journal: Cancer Prevention Research

Year: 2009

Volume: 2

Issue: 4

Pages: 310-321

ISSN (print): 1940-6207

ISSN (electronic): 1940-6215

Publisher: American Association for Cancer Research


DOI: 10.1158/1940-6207.CAPR-08-0206


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Funder referenceFunder name
N01-CN-95015National Cancer Institute and Pfizer