Primer: First do no harm - When is it appropriate to plan a cancer prevention clinical trial?

Nature Clinical Practice Oncology

Volumn 5, Issue 6, 2008, Pages 348-356

  Szabo, Eva ^a  

^a NATIONAL CANCER INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ALPHA TOCOPHEROL; ANETHOLE TRITHIONE; BETA CAROTENE; BUDESONIDE; CELECOXIB; CORTICOSTEROID; CYCLOOXYGENASE 2; FINASTERIDE; IMATINIB; MURAGLITAZAR; NONSTEROID ANTIINFLAMMATORY AGENT; PIOGLITAZONE; PLACEBO; RALOXIFENE; RETINOL; ROFECOXIB; ROSIGLITAZONE; SELENIUM; STEROID; TAMOXIFEN;

ANTINEOPLASTIC ACTIVITY; ASTHMA; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER PREVENTION; CANCER RISK; CARCINOGENESIS; CARDIOVASCULAR DISEASE; CEREBROVASCULAR ACCIDENT; CEREBROVASCULAR DISEASE; CLINICAL RESEARCH; CLINICAL TRIAL; COLON ADENOMA; DECISION MAKING; DEEP VEIN THROMBOSIS; DRUG ACTIVITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG FATALITY; DRUG SAFETY; ENDOMETRIUM CANCER; GASTROINTESTINAL DISEASE; HEART DEATH; HEART INFARCTION; HEART MUSCLE ISCHEMIA; HIGH RISK PATIENT; HUMAN; LONG TERM CARE; LUNG CANCER; LUNG EMBOLISM; NEOPLASM; NON INSULIN DEPENDENT DIABETES MELLITUS; NONHUMAN; PRIORITY JOURNAL; PROSTATE CANCER; PROTEIN TARGETING; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; SKIN CANCER; THROMBOEMBOLISM; UNSPECIFIED SIDE EFFECT;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; HUMANS; NEOPLASMS; RISK ASSESSMENT;

EID: 44649168470     PISSN: 17434254     EISSN: 17434262     Source Type: Journal    
DOI: 10.1038/ncponc1123     Document Type: Review

References (51)

1. Sporn MB and Liby KT (2005) Cancer chemoprevention: Scientific promise, clinical uncertainty. Nat Clin Pract Oncol 2: 518-525
2. Kelloff GJ et al. (2006) Progress in chemoprevention drug development: The promise of molecular biomarkers for prevention of intraepithelial neoplasia (IEN) and cancer (AACR Cancer Prevention Task Force). Clin Cancer Res 12: 3661-3697
3. Lippman SM and Heymach JV (2007) The convergent development of molecular-targeted drugs for cancer treatment and prevention. Clin Cancer Res 13: 4035-4041
4. Vogel V et al. (2006) Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes. JAMA 295: 2727-2741
5. The ATBC Study Group (1994) The effect of vitamin E and beta carotene on the incidence of lung cancer and other cancers in male smokers. The Alpha-Tocopherol Beta Carotene Cancer Prevention Study Group. N Engl J Med 330: 1029-1035
6. Weinstein IB (2002) Addiction to oncogenes-the Achilles heal of cancer. Science 297: 63-64
7. Cohen M H et al. (2005) U.S. Food and Drug Administration drug approval summary: Conversion of imatinib mesylate (STI571; Gleevec) tablets from accelerated approval to full approval: Clin Cancer Res 11: 12-19
8. Blanke CD and Corless CL (2005) State-of-the art therapy for gastrointestinal stromal tumors. Cancer Invest 23: 274-280
9. Dy GK et al. (2005) A phase II trial of imatinib (STI571) in patients with c-kit expressing relapsed small-cell lung cancer: A CALGB and NCCTG study. Ann Oncol 16: 1811-1816
10. Burger H et al. (2003) Lack of c-kit axon 11 activating mutations in c-KIT/CD117-positive SCLC tumour specimens. Eur J Cancer 39: 793-799
11. Piazza GA et al. (1997) Sulindac sulfone inhibits azoxymethane-induced colon carcinogenesis in rats without reducing prostaglandin levels. Cancer Res 57: 2909-2915
12. Wick M et al. (2002) Peroxisome proliferator-activated receptor-gamma is a target of nonsteroidal anti-inflammatory drugs mediating cyclooxygenase-independent inhibition of lung cancer cell growth. Mol Pharmacol 62: 1207-1214
13. Corpet DE and Pierre F (2005) How good are rodent models of carcinogenesis in predicting efficacy in humans? A systematic review and meta-analysis of colon chemoprevention in rats, mice and men. Eur J Cancer 41: 1911-1922
14. Green JE and Hudson T (2005) The promise of genetically engineered mice for cancer prevention studies. Nat Rev Cancer 5: 184-198
15. Hursting SD et al. (2005) The utility of genetically altered mouse models for nutrition and cancer chemoprevention research. Mutat Res 576: 80-92
16. Jacoby RF et al. (2000) The cyclooxygenase-2 inhibitor celecoxib is a potent preventive and therapeutic agent in the Min mouse model of adenomatous polyposis. Cancer Res 60: 5040-5044
17. Steinbach G et al. (2000) The affect of celecoxib, a cyclooxygenase-2 inhibitor, in familial adenomatous polyposis. N Engl J Med 342: 1946-1952
18. Bertagnolli MM et al. (2006) Celecoxib for the prevention of sporadic colorectall adenomas. N Engl J Med 355: 873-884
19. Arber N et al. (2006) Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med 355: 885-895
20. Peto R et al. (1981) Can dietary beta-carotene materially reduce human cancer rates? Nature 290: 201-208
21. Dorgan JF and Schatzkin A (1991) Antioxidant micronutrients in cancer prevention. Hematol Oncol Clin North Am 5: 43-68
22. Omenn GS et al. (1996) Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. N Engl J Med 334: 1150-1155
23. Wang XD et al. (1999) Retinoid signaling and activator protein-1 expression in ferrets given β-carotene supplements and exposed to tobacco smoke. J Natl Cancer Inst 91: 60-66
24. Anderson WF et al. (2003) Cyclooxygenase inhibition in cancer prevention and treatment. Expert Opin Pharmacother 4: 2193-2204
25. Baron JA et al. (2003) A randomized trial of aspirin to prevent colorectal adenomas. N Engl J Med 348: 891-899.
26. Sandler RS et al. (2003) A randomized trial of aspirin to prevent colorectall adenomas in patients with previous colorectal cancer. N Engl J Med 348: 883-890
27. Baron J et al. (2006) A randomized trial of rofecoxib for the chemoprevention of colorectal cancer. Gastroenterology 131: 1674-1682
28. Chan AT et al. (2007) Aspirin and the risk of colorectal cancer in relation to the expression of COX-2. N Engl J Med 356: 2131-2142
29. Meyskens FL and Szabo E (2005) Diet and cancer: The disconnect between epidemiology and randomized clinical trials. Cancer Epidemiol Biomarkers Prev 14: 1366-1369
30. Guarnieri S et al. (2007) Orange juice vs vitamin C: Effect on hydrogen peroxide-induced DNA damage in mononuclear blood cells. Br J Nutr 97: 639-643
31. Fisher B et al. (1989) A randomized clinical trial evaluating tamoxifen in the treatment of patients with node-negative breast cancer who have estrogen-receptor-positive tumors. N Engl J Med 320 479-484
32. Cummings SR et al. (1999) The effect of raloxifene on risk of breast cancer in postmenopausal women: Results from the MORE randomized trial multiple outcomes of raloxifene evaluation. JAMA 281: 2189-2197
33. Fisher B et al. (1998) Tamoxifen for Prevention of Breast Cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 190: 1371-1388
34. Klein EA et al. (2003) SELECT. the selenium and vitamin E cancer prevention trial. Urol Oncol 21: 59-65
35. Clark LC et al. (1996) Effects of selenium supplementation for cancer prevention in patients with carcinoma of the skin. JAMA 276: 1957-1963
36. Lam S et al. (2002) A randomized phase IIb trial of anethole dithiolethione in smokers with bronchial dysplasia. J Natl Cancer Inst 94: 1001-1009
37. Seiwert TY et al. (2007) The chemoradiation paradigm in head and neck cancer. Nat Clin Pract Oncol 4: 156-171
38. Bresalier RS et al. (2005) Cardiovascular events associated with rofecoxib in a colorectal adenoma chemoprevention trial. N Engl J Med 352: 1092-1102
39. Nissen SE (2006) Adverse cardiovascular effects of rofecoxib. N Engl J Med 355: 203-204
40. Nissen SE et al. (2005) Effect of muraglitazar on death and major adverse cardiovascular events in patients with type 2 diabetes mellitus. JAMA 294: 2581-2586
41. Nissen SE and Wolski K (2007) Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 356: 2457-2471
42. Dormandy JA et al. (2005) Secondary prevention of macrovascular events in patients with type 2 diabetes in the PROactive study (PROspective pioglitAzone Clinical Trial in macroVascular Events): A randomized controlled trial. Lancet 366: 1279-1289
43. Gail MH et al. (1989) Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst 81: 1879-1886
44. Bach PB et al. (2003) Variations in lung cancer risk among smokers. J Natl Cancer Inst 95: 470-478
45. Spitz MR et al. (2007) A risk model for prediction of lung cancer. J Natl Cancer Inst 99: 715-726
46. Silverman S Jr et al. (1984) Oral leukoplakia and malignant transformation: A follow-up study of 257 patients. Cancer 53 563-568
47. Rosin M P et al. (2000) Use of allelic loss to predict malignant risk for low grade epithelial dysplasia. Clin Cancer Res 6: 357-362
48. Lam S et al. (2004) A randomized phase IIb trial of Pulmicort turbuhaler (budesonide) in persons with dysplasia of the bronchial epithelium. Clin Cancer Res 10: 6502-6511
49. Grubbs CJ et al. (2007) Preventive effects of the EGFR Inhibitor Iressa alone and in combination with Targretin or Vorozole in the methylnitrosourea (MNU) induced mammary cancer model. Proc Am Assoc Cancer Res 48: 592
50. Solomon SD et al. (2005) Cardiovascular risk associated with celecoxib in a clinical trial for colorectal adenoma prevention. N Engl J Med 352: 1071-1080
51. Thompson IM et al. (2003) The influence of finasteride on the development of prostate cancer. N Engl J Med 349: 215-224