Assessing toxicity in cancer chemoprevention trials: The other side of the coin

Cancer Prevention Research

Volumn 1, Issue 7, 2008, Pages 499-502

  Goodman, Gary E ^a  

^a SWEDISH MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANIMAL; CHEMOPROPHYLAXIS; CLINICAL TRIAL; HUMAN; NEOPLASM; NOTE;

ANIMALS; CHEMOPREVENTION; CLINICAL TRIALS AS TOPIC; HUMANS; NEOPLASMS;

EID: 62349095109     PISSN: 19406207     EISSN: 19406215     Source Type: Journal    
DOI: 10.1158/1940-6207.CAPR-08-0186     Document Type: Review

References (22)

1. Bertram JS, Kolonel LN, Meyskens FL. Rationale and strategies for chemoprevention of cancer in humans. Cancer Res 1987;47:3012-31.
2. Sporn MB, Newton DL. Chemoprevention of cancer with retinoids. Fed Proc 1979;38:2528-34.
3. The α-Tocopherol, β Carotene Cancer Prevention Study Group. The effect of vitamin E and β carotene on the incidence of lung cancer and other cancers in male smokers. N Engl J Med 1994;330: 1029-35.
4. Omenn GS, Goodman GE, Thornquist MD, et al. Effects of a combination of β carotene and vitamin A on lung cancer and cardiovascular disease. N Engl J Med 1996;334:1150-5.
5. Lippman SM, Lee JJ, Karp DD, et al. Randomized phase III intergroup trial of isotretinoin to prevent second primary tumors in stage I non-small-cell lung cancer. J Natl Cancer Inst 2001;93:605-18.
6. Miller ER III, Pastor-Barriuso R, Dalal D, Riemersma RA, Appel LJ, Guallar E. Meta-analysis: highdosage vitamin E supplementation may increase all-cause mortality. Ann Intern Med 2005;142: 37-46.
7. Brown BG, Crowley J. Is there any hope for vitamin E? JAMA 2005;293:1387-90.
8. Cole BF, Baron JA, Sandler RS, et al. Folic acid for the prevention of colorectal adenomas: a randomized clinical trial. JAMA 2007;297:2351-9.
9. Bjelakovic G, Nilolova D, Gludd LL, et al. Mortality in randomized trials of antioxidant supplements for primary and secondary prevention: systematic review and meta-analysis. JAMA 2007;297:842-57.
10. Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Natl Cancer Inst 1998;90: 1371-88.
11. Vogel VG, Costantino JP, Wickerham DL, et al. Effects of tamoxifen vs. raloxifene on the risk of developing invasive breast cancer and other disease outcomes. The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 Trial. JAMA 2006;295: 2727-41.
12. Thompson IM, Goodman PJ, Tangen CM, et al.The influence of finasteride on the development of prostate cancer. N Engl J Med 2003;349: 215-24.
13. Solomon SD, McMurray JJ, Pfeffer MA, et al. Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 2005;352:1071-80.
14. McLaren CE, Fujikawa-Brooks S, Chen W-P, et al. Longitudinal assessment of air conduction audiograms in a phase III clinical trial for prevention of sporadic colorectal adenomas. Cancer Prev Res 2008;1:514-21.
15. Meykens FL, Jr., McLaren CE, Pelot D, et al. Difluoromethylornithine plus sulindac for the prevention of sporadic colorectal adenomas: a randomized placebo-controlled, double-blind trial. Cancer Prev Res 2008;1:32-8.
16. Meyskens FL, Jr., Gerner EW. Development of difluoromethylornithine (DFMO) as a chemoprevention agent. Clin Cancer Res 1999;5:945-51.
17. Giardiello FM, Hamilton SR, Krush AJ, et al. Treatment of colonic and rectal adenomas with sulindac in familial adenomatous polyposis. N Engl J Med 1993;328:1313-6.
18. Henley CM, Gerhardt HJ, Schacht J. Inhibition of inner ear ornithine decarboxylase by neomycin in-vitro. Brain Res Bull 1987;19:695-8.
19. McWilliams ML, Chen GD, Fechter LD. Characterization of the ototoxicity of difluoromethylornithine and its enantiomers. Toxicol Sci 2000;56: 124-32.
20. Nie L, Feng W, Diaz R, Gratton MA, Doyle KJ, Yamoah EN. Functional consequences of polyamine synthesis inhibition by ≻l-α- difluoromethylornithine (DFMO): cellular mechanisms for DFMO-mediated ototoxicity. J Biol Chem 2005; 280:15097-102.
21. Qu N, Ignatenko NA, Yamauchi P, et al. Inhibition of human ornithine decarboxylase activity by enantiomers of difluoromethylornithine. Biochem J 2003;375:465-70.
22. Zell JA, McLaren CE, Gerner EW, Meyskens FL. Ornithine decarboxylase (Odc)-1 gene polymorphism effects on baseline tissue polyamine levels and adenoma recurrence in a randomized phase III adenoma prevention trial of DFMO + sulindac versus placebo. J Clin Oncol 2008;26:, (May 20 suppl; abstract 1502).