Gastroenterology
Volume 129, Issue 3 , Pages 863-873 , September 2005

Randomized, Placebo-Controlled, Esophageal Squamous Cell Cancer Chemoprevention Trial of Selenomethionine and Celecoxib

  • Paul J. Limburg

      Affiliations

    • Mayo Clinic College of Medicine, Rochester, Minnesota
    • Corresponding Author InformationAddress requests for reprints to: Paul J. Limburg, MD, MPH, Division of Gastroenterology and Hepatology, Mayo Clinic, 200 First Street Southwest, Rochester, Minnesota 55905. fax: (507) 266-0350.
    • ,
  • Wenqiang Wei

      Affiliations

    • Cancer Institute, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
    • ,
  • Dennis J. Ahnen

      Affiliations

    • University of Colorado, Denver, Colorado
    • ,
  • Youlin Qiao

      Affiliations

    • Cancer Institute, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
    • ,
  • Ernest T. Hawk

      Affiliations

    • National Cancer Institute, Bethesda, Maryland
    • ,
  • Guoqing Wang

      Affiliations

    • Cancer Institute, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
    • ,
  • Carol A. Giffen

      Affiliations

    • Information Management Services, Inc, Silver Spring, Maryland
    • ,
  • Guiqi Wang

      Affiliations

    • Cancer Institute, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
    • ,
  • Mark J. Roth

      Affiliations

    • National Cancer Institute, Bethesda, Maryland
    • ,
  • Ning Lu

      Affiliations

    • Cancer Institute, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
    • ,
  • Edward L. Korn

      Affiliations

    • National Cancer Institute, Bethesda, Maryland
    • ,
  • Yurong Ma

      Affiliations

    • Dalian Medical College, Dalian, People’s Republic of China
    • ,
  • Kathleen L. Caldwell

      Affiliations

    • Centers for Disease Control and Prevention, Atlanta, Georgia
    • ,
  • Zheiwei Dong

      Affiliations

    • Cancer Institute, Chinese Academy of Medical Sciences, Beijing, People’s Republic of China
    • ,
  • Philip R. Taylor

      Affiliations

    • National Cancer Institute, Bethesda, Maryland
    • ,
  • Sanford M. Dawsey

      Affiliations

    • National Cancer Institute, Bethesda, Maryland

Received 2 November 2004 ,Accepted 2 June 2005.

References 

  1. Parkin DM , Bray FI , Devesa SS . Cancer burden in the year 2000. The global picture . Eur J Cancer . 2001;37:S4–S66
  2. Younes M , Henson DE , Ertan A , Miller CC . Incidence and survival trends of esophageal carcinoma in the United States (racial and gender differences by histological type) . Scand J Gastroenterol . 2002;37:1359–1365
  3. Polednak AP . Trends in survival for both histologic types of esophageal cancer in US Surveillance, Epidemiology and End Results areas . Int J Cancer . 2003;105:98–100
  4. Munoz N , Buiatti E . Chemoprevention of oesophageal cancer . IARC Sci Publ . 1996;136:27–33
  5. Stoner GD , Gupta A . Etiology and chemoprevention of esophageal squamous cell carcinoma . Carcinogenesis . 2001;22:1737–1746
  6. Devesa SS , Blot WJ , Fraumeni JF . Changing patterns in the incidence of esophageal and gastric carcinoma in the United States . Cancer . 1998;83:2049–2053
  7. Munoz N , Day N . Esophageal cancer . In:  Schottenfeld D ,  Fraumeni J editor. Cancer epidemiology and prevention . New York: Oxford University Press; 1996;p. 681–706
  8. Dawsey SM, Lewin KJ, Wang GQ, Liu FS, Nieberg RK, Yu Y, et al. Squamous esophageal histology and subsequent risk of squamous cell carcinoma of the esophagus. A prospective follow-up study from Linxian, China . Cancer . 1994;74:1686–1692
  9. Wang GQ, Abnet CC, Shen Q, Lewin KJ, Sun XD, Roth MJ, et al. Histologic precursors of esophageal squamous cell carcinoma (results from a 13-year prospective follow-up study in a high-risk population) . Gut . 2005;54:187–192
  10. Dawsey SM, Fleischer DE, Wang GQ, Zhou B, Kidwell JA, Lu N, et al. Mucosal iodine staining improves endoscopic visualization of squamous dysplasia and squamous cell carcinoma of the esophagus in Linxian, China . Cancer . 1998;83:220–231
  11. Jaskiewicz K , Marasas WF , Rossouw JE , Van Niekerk FE , Heine Tech EW . Selenium and other mineral elements in populations at risk for esophageal cancer . Cancer . 1988;62:2635–2639
  12. Knekt P, Aromaa A, Maatela J, Alfthan G, Aaran RK, Nikkari T, et al. Serum micronutrients and risk of cancers of low incidence in Finland . Am J Epidemiol . 1991;134:356–361
  13. Krishnaswamy K , Prasad MP , Krishna TP , Pasricha S . A case control study of selenium in cancer . Indian J Med Res . 1993;98:124–128
  14. Nayar D, Kapil U, Joshi YK, Sundaram KR, Srivastava SP, Shukla NK, et al. Association of vitamin A, zinc, selenium and magnesium with oesophageal cancer . Trop Gastroenterol . 1998;19:148–149
  15. Mark SD, Qiao YL, Dawsey SM, Wu YP, Katki H, Gunter EW, et al. Prospective study of serum selenium levels and incident esophageal and gastric cancers . J Natl Cancer Inst . 2000;92:1753–1763
  16. Rudolph RE, Vaughan TL, Kristal AR, Blount PL, Levine DS, Galipeau PC, et al. Serum selenium levels in relation to markers of neoplastic progression among persons with Barrett’s esophagus . J Natl Cancer Inst . 2003;95:750–757
  17. Clark LC, Combs GF, Turnbull BW, Slate EH, Chalker DK, Chow J, et al. Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. A randomized controlled trial. Nutritional Prevention of Cancer Study Group . JAMA . 1996;276:1957–1963
  18. Duffield-Lillico AJ, Reid ME, Turnbull BW, Combs GF, Slate EH, Fischbach LA, et al. Baseline characteristics and the effect of selenium supplementation on cancer incidence in a randomized clinical trial (a summary report of the Nutritional Prevention of Cancer Trial) . Cancer Epidemiol Biomarkers Prev . 2002;11:630–639
  19. Li JY, Taylor PR, Li B, Dawsey S, Wang GQ, Ershow AG, et al  Nutrition intervention trials in Linxian, China (multiple vitamin/mineral supplementation, cancer incidence, and disease-specific mortality among adults with esophageal dysplasia) . J Natl Cancer Inst . 1993;85:1492–1498
  20. Blot WJ, Li JY, Taylor PR, Guo W, Dawsey S, Wang GQ, et al  Nutrition intervention trials in Linxian, China (supplementation with specific vitamin/mineral combinations, cancer incidence, and disease-specific mortality in the general population) . J Natl Cancer Inst . 1993;85:1483–1492
  21. Thun MJ , Namboodiri MM , Calle EE , Flanders WD , Heath CW . Aspirin use and risk of fatal cancer . Cancer Res . 1993;53:1322–1327
  22. Farrow DC, Vaughan TL, Hansten PD, Stanford JL, Risch HA, Gammon MD, et al. Use of aspirin and other nonsteroidal anti-inflammatory drugs and risk of esophageal and gastric cancer . Cancer Epidemiol Biomarkers Prev . 1998;7:97–102
  23. Coogan PF, Rosenberg L, Palmer JR, Strom BL, Zauber AG, Stolley PD, et al. Nonsteroidal anti-inflammatory drugs and risk of digestive cancers at sites other than the large bowel . Cancer Epidemiol Biomarkers Prev . 2000;9:119–123
  24. Bosetti C , Talamini R , Franceschi S , Negri E , Garavello W , La Vecchia C . Aspirin use and cancers of the upper aerodigestive tract . Br J Cancer . 2003;88:672–674
  25. Corley DA , Kerlikowske K , Verma R , Buffler P . Protective association of aspirin/NSAIDs and esophageal cancer (a systematic review and meta-analysis) . Gastroenterology . 2003;124:47–56
  26. Centers for Disease Control and Prevention DoLS . Selenium in serum, DLS method code: 2001-01/OD. CLIA methods. Adopted September 21, 2001 . In: Atlanta, GA: Centers for Disease Control and Prevention; 2001;p. 1–33
  27. Green S , Benedetti J , Crowley J . In: Clinical trials in oncology . 2nd ed. Boca Raton, FL: Chapman & Hall; 2003;p. 171
  28. Graubard B , Korn E . Choice of column scores in testing independence in ordered 2 × K contingency tables . Biometrics . 1987;43:471–476
  29. Whanger PD . Selenium and its relationship to cancer (an update) . Br J Nutr . 2004;91:11–28
  30. Wang GQ, Dawsey SM, Li JY, Taylor PR, Li B, Blot WJ, et al  Effects of vitamin/mineral supplementation on the prevalence of histological dysplasia and early cancer of the esophagus and stomach (results from the General Population Trial in Linxian, China) . Cancer Epidemiol Biomarkers Prev . 1994;3:161–166
  31. Fleming J , Ghose A , Harrison PR . Molecular mechanisms of cancer prevention by selenium compounds . Nutr Cancer . 2001;40:42–49
  32. Patterson BH , Levander OA . Naturally occurring selenium compounds in cancer chemoprevention trials (a workshop summary) . Cancer Epidemiol Biomarkers Prev . 1997;6:63–69
  33. Greenwald P . Cancer prevention clinical trials . J Clin Oncol . 2002;20:14S–22S
  34. Li M , Lotan R , Levin B , Tahara E , Lippman SM , Xu XC . Aspirin induction of apoptosis in esophageal cancer (a potential for chemoprevention) . Cancer Epidemiol Biomarkers Prev . 2000;9:545–549
  35. Fosslien E . Biochemistry of cyclooxygenase (COX)-2 inhibitors and molecular pathology of COX-2 in neoplasia . Crit Rev Clin Lab Sci . 2000;37:431–502
  36. Steinbach G, Lynch PM, Phillips RK, Wallace MH, Hawk E, Gordon GB, et al. The effect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis . N Engl J Med . 2000;342:1946–1952
  37. Baron JA, Cole BF, Sandler RS, Haile RW, Ahnen D, Bresalier R, et al. A randomized trial of aspirin to prevent colorectal adenomas . N Engl J Med . 2003;348:891–899
  38. Sandler RS, Halabi S, Baron JA, Budinger S, Paskett E, Keresztes R, et al. A randomized trial of aspirin to prevent colorectal adenomas in patients with previous colorectal cancer . N Engl J Med . 2003;348:883–890
  39. Maaser K, Daubler P, Barthel B, Heine B, von Lampe B, Stein H, et al. Oesophageal squamous cell neoplasia in head and neck cancer patients (upregulation of COX-2 during carcinogenesis) . Br J Cancer . 2003;88:1217–1222
  40. Shamma A, Yamamoto H, Doki Y, Okami J, Kondo M, Fujiwara Y, et al. Up-regulation of cyclooxygenase-2 in squamous carcinogenesis of the esophagus . Clin Cancer Res . 2000;6:1229–1238
  41. Kelloff GJ, Sigman CC, Johnson KM, Boone CW, Greenwald P, Crowell JA, et al. Perspectives on surrogate end points in the development of drugs that reduce the risk of cancer . Cancer Epidemiol Biomarkers Prev . 2000;9:127–137
  42. O’Shaughnessy JA, Kelloff GJ, Gordon GB, Dannenberg AJ, Hong WK, Fabian CJ, et al. Treatment and prevention of intraepithelial neoplasia (an important target for accelerated new agent development) . Clin Cancer Res . 2002;8:314–346
  43. Roth MJ, Hu N, Emmert-Buck MR, Wang QH, Dawsey SM, Li G, et al. Genetic progression and heterogeneity associated with the development of esophageal squamous cell carcinoma . Cancer Res . 2001;61:4098–4104
  44. Lu N, Hu N, Li WJ, Roth MJ, Wang C, Su H, et al. Microsatellite alterations in esophageal dysplasia and squamous cell carcinoma from laser capture microdissected endoscopic biopsies . Cancer Lett . 2003;189:137–145
  45. Topol EJ . Failing the public health—rofecoxib, Merck, and the FDA . N Engl J Med . 2004;351:1707–1709

 Supported by National Cancer Institute (NCI) contract N01-RC-91019. P.J.L. was an NCI Cancer Prevention Fellow at the time the study was initiated and was further supported in part by NCI Career Development Award K07-CA-92216 after becoming a faculty member at the Mayo Clinic College of Medicine.

 The authors have no conflicts of interest to report. The corresponding author had full access to the data in the study and had final responsibility for the decision to submit for publication.

PII: S0016-5085(05)01126-1

doi: 10.1053/j.gastro.2005.06.024

Gastroenterology
Volume 129, Issue 3 , Pages 863-873 , September 2005

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