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Previous Volume 342:1946-1952 June 29, 2000 Number 26 Next

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ABSTRACT

Background Patients with familial adenomatous polyposis have a nearly 100 percent risk of colorectal cancer. In this disease, the chemopreventive effects of nonsteroidal antiinflammatory drugs may be related to their inhibition of cyclooxygenase-2.

Methods We studied the effect of celecoxib, a selective cyclooxygenase-2 inhibitor, on colorectal polyps in patients with familial adenomatous polyposis. In a double-blind, placebo-controlled study, we randomly assigned 77 patients to treatment with celecoxib (100 or 400 mg twice daily) or placebo for six months. Patients underwent endoscopy at the beginning and end of the study. We determined the number and size of polyps from photographs and videotapes; the response to treatment was expressed as the mean percent change from base line.

Results At base line, the mean (±SD) number of polyps in focal areas where polyps were counted was 15.5±13.4 in the 15 patients assigned to placebo, 11.5±8.5 in the 32 patients assigned to 100 mg of celecoxib twice a day, and 12.3±8.2 in the 30 patients assigned to 400 mg of celecoxib twice a day (P=0.66 for the comparison among groups). After six months, the patients receiving 400 mg of celecoxib twice a day had a 28.0 percent reduction in the mean number of colorectal polyps (P=0.003 for the comparison with placebo) and a 30.7 percent reduction in the polyp burden (the sum of polyp diameters) (P=0.001), as compared with reductions of 4.5 and 4.9 percent, respectively, in the placebo group. The improvement in the extent of colorectal polyposis in the group receiving 400 mg twice a day was confirmed by a panel of endoscopists who reviewed the videotapes. The reductions in the group receiving 100 mg of celecoxib twice a day were 11.9 percent (P=0.33 for the comparison with placebo) and 14.6 percent (P=0.09), respectively. The incidence of adverse events was similar among the groups.

Conclusions In patients with familial adenomatous polyposis, six months of twice-daily treatment with 400 mg of celecoxib, a cyclooxygenase-2 inhibitor, leads to a significant reduction in the number of colorectal polyps.

Source Information

From the University of Texas M.D. Anderson Cancer Center, Houston (G.S., P.M.L., N.W., Y.S., T.F., L.-K.S., B.L.); the Imperial Cancer Research Fund, St. Mark's Hospital, London (R.K.S.P., M.H.W., B.S.); the National Cancer Institute, Bethesda, Md. (E.H.); and G.D. Searle, Skokie, Ill. (G.B.G.).

Address reprint requests to Dr. Steinbach at the University of Texas M.D. Anderson Cancer Center, Division of Cancer Prevention, Box 203, 1515 Holcombe Blvd., Houston, TX 77030, or at gsteinb{at}aol.com.

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• Bertagnolli, M. M., Eagle, C. J., Zauber, A. G., Redston, M., Solomon, S. D., Kim, K., Tang, J., Rosenstein, R. B., Wittes, J., Corle, D., Hess, T. M., Woloj, G. M., Boisserie, F., Anderson, W. F., Viner, J. L., Bagheri, D., Burn, J., Chung, D. C., Dewar, T., Foley, T. R., Hoffman, N., Macrae, F., Pruitt, R. E., Saltzman, J. R., Salzberg, B., Sylwestrowicz, T., Gordon, G. B., Hawk, E. T., the APC Study Investigators, (2006). Celecoxib for the prevention of sporadic colorectal adenomas.. NEJM 355: 873-884 [Abstract] [Full Text]  
• Mazhar, D., Ngan, S. (2006). C-reactive protein and colorectal cancer.. QJM 99: 555-559 [Full Text]  
• Eisinger, A. L., Nadauld, L. D., Shelton, D. N., Peterson, P. W., Phelps, R. A., Chidester, S., Stafforini, D. M., Prescott, S. M., Jones, D. A. (2006). The Adenomatous Polyposis Coli Tumor Suppressor Gene Regulates Expression of Cyclooxygenase-2 by a Mechanism That Involves Retinoic Acid. J. Biol. Chem. 281: 20474-20482 [Abstract] [Full Text]  
• Swamy, M. V., Patlolla, J. M.R., Steele, V. E., Kopelovich, L., Reddy, B. S., Rao, C. V. (2006). Chemoprevention of Familial Adenomatous Polyposis by Low Doses of Atorvastatin and Celecoxib Given Individually and in Combination to APCMin Mice.. Cancer Res. 66: 7370-7377 [Abstract] [Full Text]  
• Glebov, O. K., Rodriguez, L. M., Lynch, P., Patterson, S., Lynch, H., Nakahara, K., Jenkins, J., Cliatt, J., Humbyrd, C.-J., DeNobile, J., Soballe, P., Gallinger, S., Buchbinder, A., Gordon, G., Hawk, E., Kirsch, I. R. (2006). Celecoxib treatment alters the gene expression profile of normal colonic mucosa.. Cancer Epidemiol. Biomarkers Prev. 15: 1382-1391 [Abstract] [Full Text]  
• Kaidi, A., Qualtrough, D., Williams, A. C., Paraskeva, C. (2006). Direct Transcriptional Up-regulation of Cyclooxygenase-2 by Hypoxia-Inducible Factor (HIF)-1 Promotes Colorectal Tumor Cell Survival and Enhances HIF-1 Transcriptional Activity during Hypoxia.. Cancer Res. 66: 6683-6691 [Abstract] [Full Text]  
• Carothers, A. M., Moran, A. E., Cho, N. L., Redston, M., Bertagnolli, M. M. (2006). Changes in Antitumor Response in C57BL/6J-Min/+ Mice during Long-term Administration of a Selective Cyclooxygenase-2 Inhibitor.. Cancer Res. 66: 6432-6438 [Abstract] [Full Text]  
• Kelloff, G. J., Lippman, S. M., Dannenberg, A. J., Sigman, C. C., Pearce, H. L., Reid, B. J., Szabo, E., Jordan, V. C., Spitz, M. R., Mills, G. B., Papadimitrakopoulou, V. A., Lotan, R., Aggarwal, B. B., Bresalier, R. S., Kim, J., Arun, B., Lu, K. H., Thomas, M. E., Rhodes, H. E., Brewer, M. A., Follen, M., Shin, D. M., Parnes, H. L., Siegfried, J. M., Evans, A. A., Blot, W. J., Chow, W.-H., Blount, P. L., Maley, C. C., Wang, K. K., Lam, S., Lee, J. J., Dubinett, S. M., Engstrom, P. F., Meyskens, F. L. Jr., O'Shaughnessy, J., Hawk, E. T., Levin, B., Nelson, W. G., Hong, W. K., for the AACR Task Force on Cancer Prevention, (2006). Progress in Chemoprevention Drug Development: The Promise of Molecular Biomarkers for Prevention of Intraepithelial Neoplasia and Cancer--A Plan to Move Forward. Clin. Cancer Res. 12: 3661-3697 [Abstract] [Full Text]  
• Grosch, S., Maier, T. J., Schiffmann, S., Geisslinger, G. (2006). Cyclooxygenase-2 (COX-2)-independent anticarcinogenic effects of selective COX-2 inhibitors.. JNCI J Natl Cancer Inst 98: 736-747 [Abstract] [Full Text]  
• Milano, M, Guerin, O (2006). Recent advances in targeted therapies for colorectal cancer. J Oncol Pharm Pract 12: 69-73 [Abstract]  
• Mrozek, E., Kloos, R. T., Ringel, M. D., Kresty, L., Snider, P., Arbogast, D., Kies, M., Munden, R., Busaidy, N., Klein, M. J., Sherman, S. I., Shah, M. H. (2006). Phase II Study of Celecoxib in Metastatic Differentiated Thyroid Carcinoma. J. Clin. Endocrinol. Metab. 91: 2201-2204 [Abstract] [Full Text]  
• Reckamp, K. L., Krysan, K., Morrow, J. D., Milne, G. L., Newman, R. A., Tucker, C., Elashoff, R. M., Dubinett, S. M., Figlin, R. A. (2006). A phase I trial to determine the optimal biological dose of celecoxib when combined with erlotinib in advanced non-small cell lung cancer.. Clin. Cancer Res. 12: 3381-3388 [Abstract] [Full Text]  
• Yiu, G. K., Toker, A. (2006). NFAT Induces Breast Cancer Cell Invasion by Promoting the Induction of Cyclooxygenase-2. J. Biol. Chem. 281: 12210-12217 [Abstract] [Full Text]  
• Reddy, B. S., Wang, C. X., Kong, A.-N., Khor, T. O., Zheng, X., Steele, V. E., Kopelovich, L., Rao, C. V. (2006). Prevention of azoxymethane-induced colon cancer by combination of low doses of atorvastatin, aspirin, and celecoxib in f 344 rats.. Cancer Res. 66: 4542-4546 [Abstract] [Full Text]  
• Dey, M., Ribnicky, D., Kurmukov, A. G., Raskin, I. (2006). In Vitro and in Vivo Anti-Inflammatory Activity of a Seed Preparation Containing Phenethylisothiocyanate. J. Pharmacol. Exp. Ther. 317: 326-333 [Abstract] [Full Text]  
• Souaze, F., Viardot-Foucault, V., Roullet, N., Toy-Miou-Leong, M., Gompel, A., Bruyneel, E., Comperat, E., Faux, M. C, Mareel, M., Rostene, W., Flejou, J.-F., Gespach, C., Forgez, P. (2006). Neurotensin receptor 1 gene activation by the Tcf/{beta}-catenin pathway is an early event in human colonic adenomas. Carcinogenesis 27: 708-716 [Abstract] [Full Text]  
• Pruthi, R. S., Derksen, J. E., Moore, D., Carson, C. C., Grigson, G., Watkins, C., Wallen, E. (2006). Phase II Trial of Celecoxib in Prostate-Specific Antigen Recurrent Prostate Cancer after Definitive Radiation Therapy or Radical Prostatectomy.. Clin. Cancer Res. 12: 2172-2177 [Abstract] [Full Text]  
• Lippman, S. M., Lee, J. J. (2006). Reducing the "Risk" of Chemoprevention: Defining and Targeting High Risk--2005 AACR Cancer Research and Prevention Foundation Award Lecture.. Cancer Res. 66: 2893-2903 [Abstract] [Full Text]  
• Castells, A., Paya, A., Alenda, C., Rodriguez-Moranta, F., Agrelo, R., Andreu, M., Pinol, V., Castellvi-Bel, S., Jover, R., Llor, X., Pons, E., Elizalde, J. I., Bessa, X., Alcedo, J., Salo, J., Medina, E., Naranjo, A., Esteller, M., Pique, J. M., for the Gastrointestinal Oncology Group of the Spa, (2006). Cyclooxygenase 2 expression in colorectal cancer with DNA mismatch repair deficiency.. Clin. Cancer Res. 12: 1686-1692 [Abstract] [Full Text]  
• Chen, T., Hwang, H., Rose, M. E., Nines, R. G., Stoner, G. D. (2006). Chemopreventive Properties of Black Raspberries in N-Nitrosomethylbenzylamine-Induced Rat Esophageal Tumorigenesis: Down-regulation of Cyclooxygenase-2, Inducible Nitric Oxide Synthase, and c-Jun.. Cancer Res. 66: 2853-2859 [Abstract] [Full Text]  
• Tanaka, S., Haruma, K., Yoshihara, M., Kajiyama, G., Kira, K., Amagase, H., Chayama, K. (2006). Aged Garlic Extract Has Potential Suppressive Effect on Colorectal Adenomas in Humans. J. Nutr. 136: 821S-826S [Abstract] [Full Text]