Abstract
In order to improve the early detection and diagnosis of cancer, give more accurate prognoses, stratify individuals by risk, predict response to treatment, and help the transition of basic research into clinical application, biomarkers are needed that accurately represent or predict clinical outcomes. To be useful in trials for chemopreventive agent development, biomarkers must be subject to modulation, easy to obtain and quantify, and have biological meaning, ideally representing steps in well-understood carcinogenic pathways. Though difficult to validate fully, wisely chosen biomarkers in early-phase trials can inform the prioritization of large-scale, long-term trials that measure clinical outcomes. When well-designed, smaller trials using biomarkers as surrogate endpoints should promote faster decisions regarding which targeted preventive agents to pursue, promising greater progress in the personalization of medicine. Biomarkers could become useful in distinguishing indolent from aggressive forms of ductal carcinoma in situ as well as localized invasive breast and prostate cancer, lesions that are often overtreated. Chemopreventive strategies that reduce the progression of early forms of premalignancy can benefit patients not only by reducing their risk of cancer and death from cancer but also by reducing their need for invasive interventions. Genomic and proteomic methods offer the possibility of revealing new potential markers, especially for diseases whose biology is complex or not well understood. Panels of markers may be used to accommodate the molecular heterogeneity of cancers. Biomarkers in phase 2 prevention trials of combinations of chemopreventive drugs have been used to demonstrate synergistic action of multiple agents, allowing use of lower doses, with less toxicity, a critical feature of interventions intended for cancer prevention.
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Abbreviations
- AI:
-
Aromatase Inhibitor
- ACS:
-
American Cancer Society
- APC:
-
Adenoma Prevention with Celecoxib Trial
- APC :
-
Adenomatous polyposis coli gene
- BCPT:
-
Breast Cancer Prevention Trial
- Bcl-2:
-
B cell lymphoma 2 protein
- BRCA :
-
Breast cancer gene
- CD10:
-
A zinc-dependent metalloprotease enzyme
- CDH1 :
-
Cadherin gene
- CEA:
-
Carcinoembryonic antigen
- COX2:
-
Cyclooxygenase 2
- CT:
-
Computed tomography
- DCIS:
-
Ductal carcinoma in situ
- DCC :
-
Deleted in Colorectal Cancer gene
- DFMO:
-
α-difluoromethylornithine
- DHT:
-
Dihydrotestosterone
- DNA:
-
Deoxyribonucleic acid
- EDRN:
-
Early Detection Research Network
- EGF:
-
Epidermal growth factor
- EGFR:
-
Epidermal growth factor receptor
- ETS :
-
E-twenty six
- ETV :
-
ETS translocation variant
- ERG :
-
ETS related gene
- ER-:
-
Estrogen receptor-negative
- ER+:
-
Estrogen receptor-positive
- FDA:
-
Food and Drug Administration
- FHIT :
-
Fragile Histidine Triad gene
- GI:
-
Gastrointestinal
- GGO:
-
Ground-glass opacity
- HbA1C:
-
Glycated hemoglobin
- HER2:
-
Human epidermal growth factor receptor 2
- HPV:
-
Human papilllomavirus
- HRT:
-
Hormone replacement therapy
- IBC:
-
Invasive breast cancer
- IBIS:
-
International Breast Intervention Study
- IEN:
-
Intra-epithelial neoplasia
- IGF-1:
-
Insulin-like growth factor 1
- IGFBP-3:
-
Insulin-like growth factor binding protein 3
- Ki-67:
-
A protein that in humans is encoded by the MKI67 gene
- KRAS :
-
Kirsten ras sarcoma viral oncogene
- LAMR1:
-
laminin receptor 1
- LGD1069:
-
Bexarotene (Targretin)
- MCM2:
-
Minichromosome maintenance protein
- MGMT :
-
O6-methylguanine–DNA methyltransferase gene
- MiB2:
-
Breast cancer marker of proliferation
- NCI:
-
National Cancer Institute
- NLST:
-
National Lung Screening Trial
- NSABP:
-
National Surgical Adjuvant Breast and Bowel Project
- NSAID:
-
Non-steroidal anti-inflammatory drug
- P53:
-
A tumor suppressor protein that in humans is encoded by the TP53 gene
- P16 :
-
A tumor suppressor gene, also known as cyclin-dependent kinase inhibitor 2A (CDKN2A) gene
- PARP:
-
Poly (ADP-ribose) polymerase
- PCNA:
-
Proliferating cell nuclear antigen
- PCA3:
-
Prostate cancer antigen 3
- PCPT:
-
Prostate Cancer Prevention Trial
- PCR:
-
Polymerase chain reaction
- PGP9.5:
-
Protein gene product 9.5 gene
- PLCO:
-
Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial
- PR:
-
Progesterone receptor
- PSA:
-
Prostate-specific antigen
- PSMA:
-
Prostate-specific membrane antigen
- RASSF1A :
-
Ras ASSociation domain Family 1A gene
- RNA:
-
Ribonucleic acid
- RPFNA:
-
Random periareolar fine-needle aspiration
- RXR:
-
Retinoid X receptor
- S100A7:
-
Protein S100-A7 encoded by the S100A7 gene
- SEB:
-
Surrogate Endpoint Biomarker
- SELECT:
-
Selenium and Vitamin E Cancer Prevention Trial
- SERMS:
-
Selective estrogen receptor modulators
- SPINK1:
-
Pancreatic secretory trypsin inhibitor
- STAR:
-
Study of Tamoxifen and Raloxifene
- SWOG:
-
Southwest Oncology Group
- TGFβ:
-
Transforming growth factor beta
- TMPRSS2 :
-
Transmembrane protease, serine 2
References
Ahlquist DA (2009) Next-generation stool DNA testing: expanding the scope. Gastroenterology 136:2068–2073
Ahlquist DA, Sargent DJ, Loprinzi CL, Levin TR, Rex DK, Ahnen DJ, Knigge K, Lance MP, Burgart LJ, Hamilton SR, Allison JE, Lawson MJ, Devens ME, Harrington JJ, Hillman SL (2008) Stool DNA and occult blood testing for screen detection of colorectal neoplasia. Ann Intern Med 149(441–50):W81
Allred DC (2009) Terminology, natural history, and taxonomy of ductal carcinoma in situ. NIH State-of-the-Science Conference: Diagnosis and Management of Ductal Carcinoma In Situ (DCIS). September 22–24, Bethesda, MD. NIH State-of-the-Science Conference: Diagnosis and Management of Ductal Carcinoma In Situ (DCIS). September 22–24, Bethesda, MD. http://consensus.nih.gov/2009/dcisstatement.htm. Accessed February 26, 2010
Anders C, Carey LA (2008) Understanding and treating triple-negative breast cancer. Oncology (Williston Park) 22:1233–1239
Andriole GL, Crawford ED, Grubb RL III, Buys SS, Chia D, Church TR, Fouad MN, Gelmann EP, Kvale PA, Reding DJ, Weissfeld JL, Yokochi LA, O’Brien B, Clapp JD, Rathmell JM, Riley TL, Hayes RB, Kramer BS, Izmirlian G, Miller AB, Pinsky PF, Prorok PC, Gohagan JK, Berg CD (2009) Mortality results from a randomized prostate-cancer screening trial. N Engl J Med 360:1310–1319
Arber N, Eagle CJ, Spicak J, Racz I, Dite P, Hajer J, Zavoral M, Lechuga MJ, Gerletti P, Tang J, Rosenstein RB, Macdonald K, Bhadra P, Fowler R, Wittes J, Zauber AG, Solomon SD, Levin B (2006) Celecoxib for the prevention of colorectal adenomatous polyps. N Engl J Med 355:885–895
Arun B, Valero V, Logan C, Broglio K, Rivera E, Brewster A, Yin G, Green M, Kuerer H, Gong Y, Browne D, Hortobagyi GN, Sneige N (2007) Comparison of ductal lavage and random periareolar fine needle aspiration as tissue acquisition methods in early breast cancer prevention trials. Clin Cancer Res 13:4943–4948
Atchley DP, Albarracin CT, Lopez A, Valero V, Amos CI, Gonzalez-Angulo AM, Hortobagyi GN, Arun BK (2008) Clinical and pathologic characteristics of patients with BRCA-positive and BRCA-negative breast cancer. J Clin Oncol 26:4282–4288
Baker SG (2009) Improving the biomarker pipeline to develop and evaluate cancer screening tests. J Natl Cancer Inst 101:1116–1119
Belinsky SA (2004) Gene-promoter hypermethylation as a biomarker in lung cancer. Nat Rev Cancer 4:707–717
Belinsky SA, Liechty KC, Gentry FD, Wolf HJ, Rogers J, Vu K, Haney J, Kennedy TC, Hirsch FR, Miller Y, Franklin WA, Herman JG, Baylin SB, Bunn PA, Byers T (2006) Promoter hypermethylation of multiple genes in sputum precedes lung cancer incidence in a high-risk cohort. Cancer Res 66:3338–3344
Bertagnolli MM, Eagle CJ, Zauber AG, Redston M, Solomon SD, Kim K, Tang J, Rosenstein RB, Wittes J, Corle D, Hess TM, Woloj GM, Boisserie F, Anderson WF, Viner JL, Bagheri D, Burn J, Chung DC, Dewar T, Foley TR, Hoffman N, Macrae F, Pruitt RE, Saltzman JR, Salzberg B, Sylwestrowicz T, Gordon GB, Hawk ET (2006) Celecoxib for the prevention of sporadic colorectal adenomas. N Engl J Med 355:873–884
Boecker W, Moll R, Dervan P, Buerger H, Poremba C, Diallo RI, Herbst H, Schmidt A, Lerch MM, Buchwalow IB (2002) Usual ductal hyperplasia of the breast is a committed stem (progenitor) cell lesion distinct from atypical ductal hyperplasia and ductal carcinoma in situ. J Pathol 198:458–467
Boulton SJ (2006) Cellular functions of the BRCA tumour-suppressor proteins. Biochem Soc Trans 34:633–645
Cancer Biomarkers Research Group (2008) EDRN fourth report: investing in translational research on biomarkers of early cancer and cancer risk. NIH Publication No. 07-6135, 1-126. 2008, Bethesda, MD, National Institutes of Health, National Cancer Institute. http://edrn.nci.nih.gov/docs/progress-reports/edrn_4th-report_200801.pdf. Accessed February 26, 2010
Chen J, Pee D, Ayyagari R, Graubard B, Schairer C, Byrne C, Benichou J, Gail MH (2006) Projecting absolute invasive breast cancer risk in white women with a model that includes mammographic density. J Natl Cancer Inst 98:1215–1226
Chlebowski RT, McTiernan A (2003) Biological significance of interventions that change breast density. J Natl Cancer Inst 95:4–5
Chow CK, Venzon D, Jones EC, Premkumar A, O’Shaughnessy J, Zujewski J (2000) Effect of tamoxifen on mammographic density. Cancer Epidemiol Biomarkers Prev 9:917–921
Cuzick J (2005) Aromatase inhibitors for breast cancer prevention. J Clin Oncol 23:1636–1643
Cuzick J (2008) IBIS II: a breast cancer prevention trial in postmenopausal women using the aromatase inhibitor anastrozole. Expert Rev Anticancer Ther 8:1377–1385
Cuzick J, Powles T, Veronesi U, Forbes J, Edwards R, Ashley S, Boyle P (2003) Overview of the main outcomes in breast-cancer prevention trials. Lancet 361:296–300
Cuzick J, Warwick J, Pinney E, Warren RM, Duffy SW (2004) Tamoxifen and breast density in women at increased risk of breast cancer. J Natl Cancer Inst 96:621–628
de Azambuja E, Cardoso F, de Castro G, Jr., Colozza M, Mano MS, Durbecq V, Sotiriou C, Larsimont D, Piccart-Gebhart MJ, Paesmans M (2007) Ki-67 as prognostic marker in early breast cancer: a meta-analysis of published studies involving 12,155 patients. Br J Cancer 96:1504–1513
Demark-Wahnefried W, Polascik TJ, George SL, Switzer BR, Madden JF, Ruffin MT, Snyder DC, Owzar K, Hars V, Albala DM, Walther PJ, Robertson CN, Moul JW, Dunn BK, Brenner D, Minasian L, Stella P, Vollmer RT (2008) Flaxseed supplementation (not dietary fat restriction) reduces prostate cancer proliferation rates in men presurgery. Cancer Epidemiol Biomarkers Prev 17:3577–3587
Drazen JM (2005) COX-2 inhibitors–a lesson in unexpected problems. N Engl J Med 352:1131–1132
Dunn BK, Richmond E, Ryan A, Ford LG (2010) A nutrient approach to prostate cancer prevention: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). Nutr Cancer (in press)
Eng-Wong J, Zujewski JA (2004) Raloxifene and its role in breast cancer prevention. Expert Rev Anticancer Ther 4:523–532
Eng-Wong J, Orzano-Birgani J, Chow CK, Venzon D, Yao J, Galbo CE, Zujewski JA, Prindiville S (2008) Effect of raloxifene on mammographic density and breast magnetic resonance imaging in premenopausal women at increased risk for breast cancer. Cancer Epidemiol Biomarkers Prev 17:1696–1701
Fabian CJ, Kimler BF (2006) Mammographic density: use in risk assessment and as a biomarker in prevention trials. J Nutr 136:2705S–2708S
Fabian CJ, Kimler BF (2007) Use of biomarkers for breast cancer risk assessment and prevention. J Steroid Biochem Mol Biol 106:31–39
Fabian CJ, Kimler BF, Brady DA, Mayo MS, Chang CH, Ferraro JA, Zalles CM, Stanton AL, Masood S, Grizzle WE, Boyd NF, Arneson DW, Johnson KA (2002) A phase II breast cancer chemoprevention trial of oral alpha-difluoromethylornithine: breast tissue, imaging, and serum and urine biomarkers. Clin Cancer Res 8:3105–3117
Fabian CJ, Kimler BF, Anderson J, Tawfik OW, Mayo MS, Burak WE Jr, O’Shaughnessy JA, Albain KS, Hyams DM, Budd GT, Ganz PA, Sauter ER, Beenken SW, Grizzle WE, Fruehauf JP, Arneson DW, Bacus JW, Lagios MD, Johnson KA, Browne D (2004) Breast cancer chemoprevention phase I evaluation of biomarker modulation by arzoxifene, a third generation selective estrogen receptor modulator. Clin Cancer Res 10:5403–5417
Fabian CJ, Kimler BF, Mayo MS, Khan SA (2005) Breast-tissue sampling for risk assessment and prevention. Endocr Relat Cancer 12:185–213
Fackler MJ, McVeigh M, Mehrotra J, Blum MA, Lange J, Lapides A, Garrett E, Argani P, Sukumar S (2004) Quantitative multiplex methylation-specific PCR assay for the detection of promoter hypermethylation in multiple genes in breast cancer. Cancer Res 64:4442–4452
Farmer H, McCabe N, Lord CJ, Tutt AN, Johnson DA, Richardson TB, Santarosa M, Dillon KJ, Hickson I, Knights C, Martin NM, Jackson SP, Smith GC, Ashworth A (2005) Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy. Nature 434:917–921
Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, Vogel V, Robidoux A, Dimitrov N, Atkins J, Daly M, Wieand S, Tan-Chiu E, Ford L, Wolmark N (1998) Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 90:1371–1388
Fisher B, Costantino JP, Wickerham DL, Cecchini RS, Cronin WM, Robidoux A, Bevers TB, Kavanah MT, Atkins JN, Margolese RG, Runowicz CD, James JM, Ford LG, Wolmark N (2005) Tamoxifen for the prevention of breast cancer: current status of the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Natl Cancer Inst 97:1652–1662
Fleming TR (2005) Surrogate endpoints and FDA’s accelerated approval process. Health Aff (Millwood) 24:67–78
Fleming TR, DeMets DL (1996) Surrogate end points in clinical trials: are we being misled? Ann Intern Med 125:605–613
Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, Mortimer P, Swaisland H, Lau A, O’Connor MJ, Ashworth A, Carmichael J, Kaye SB, Schellens JH, de Bono JS (2009) Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med 361:123–134
Frank DH, Kimler BF, Fabian CJ, Ranger-Moore J, Yozwiak M, Bartels HG, Alberts DS, Bartels PH (2009) Digital image analysis of breast epithelial cells collected by random periareolar fine-needle aspirates (RPFNA) from women at high risk for breast cancer taking hormone replacement and the aromatase inhibitor, letrozole, for six months. Breast Cancer Res Treat 115:661–668
Freedman M, San MJ, O’Gorman J, Eckert S, Lippman ME, Lo SC, Walls EL, Zeng J (2001) Digitized mammography: a clinical trial of postmenopausal women randomly assigned to receive raloxifene, estrogen, or placebo. J Natl Cancer Inst 93:51–56
Gail MH, Brinton LA, Byar DP, Corle DK, Green SB, Schairer C, Mulvihill JJ (1989) Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst 81:1879–1886
Gohagan JK, Prorok PC, Hayes RB, Kramer BS (2000) The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial of the National Cancer Institute: history, organization, and status. Control Clin Trials 21:251S–272S
Goss PE, Richardson H, Chlebowski R, Johnston D, Sarto GE, Maunsell E, Ingle JN, Ales-Martinez JE (2007) National Cancer Institute of Canada Clinical Trials Group MAP.3 Trial: evaluation of exemestane to prevent breast cancer in postmenopausal women. Clin Breast Cancer 7:895–900
Hatsukami DK, Rennard S, Jorenby D, Fiore M, Koopmeiners J, de Vos A, Horwith G, Pentel PR (2005) Safety and immunogenicity of a nicotine conjugate vaccine in current smokers. Clin Pharmacol Ther 78:456–467
Imperiale TF, Ransohoff DF, Itzkowitz SH, Turnbull BA, Ross ME (2004) Fecal DNA versus fecal occult blood for colorectal-cancer screening in an average-risk population. N Engl J Med 351:2704–2714
Itzkowitz SH (2009) Incremental advances in excremental cancer detection tests. J Natl Cancer Inst 101:1225–1227
Jones LP, Li M, Halama ED, Ma Y, Lubet R, Grubbs CJ, Deng CX, Rosen EM, Furth PA (2005) Promotion of mammary cancer development by tamoxifen in a mouse model of BRCA1-mutation-related breast cancer. Oncogene 24:3554–3562
Jonsson S, Varella-Garcia M, Miller YE, Wolf HJ, Byers T, Braudrick S, Kiatsimkul P, Lewis M, Kennedy TC, Keith RL, Bjornsson J, McWilliams A, Lam S, Hirsch FR, Franklin WA (2008) Chromosomal aneusomy in bronchial high-grade lesions is associated with invasive lung cancer. Am J Respir Crit Care Med 177:342–347
Kelloff GJ, Lippman SM, Dannenberg AJ, Sigman CC, Pearce HL, Reid BJ, Szabo E, Jordan VC, Spitz MR, Mills GB, Papadimitrakopoulou VA, Lotan R, Aggarwal BB, Bresalier RS, Kim J, Arun B, Lu KH, Thomas ME, Rhodes HE, Brewer MA, Follen M, Shin DM, Parnes HL, Siegfried JM, Evans AA, Blot WJ, Chow WH, Blount PL, Maley CC, Wang KK, Lam S, Lee JJ, Dubinett SM, Engstrom PF, Meyskens FL Jr, O’Shaughnessy J, Hawk ET, Levin B, Nelson WG, Hong WK (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
Kong G, Kim HT, Wu K, DeNardo D, Hilsenbeck SG, Xu XC, Lamph WW, Bissonnette R, Dannenberg AJ, Brown PH (2005) The retinoid X receptor-selective retinoid, LGD1069, down-regulates cyclooxygenase-2 expression in human breast cells through transcription factor crosstalk: implications for molecular-based chemoprevention. Cancer Res 65:3462–3469
Kramer BS, Hagerty KL, Justman S, Somerfield MR, Albertsen PC, Blot WJ, Ballentine CH, Costantino JP, Epstein JI, Godley PA, Harris RP, Wilt TJ, Wittes J, Zon R, Schellhammer P (2009) Use of 5-alpha-reductase inhibitors for prostate cancer chemoprevention: American Society of Clinical Oncology/American Urological Association 2008 Clinical Practice Guideline. J Clin Oncol 27:1502–1516
Kumar AS, Benz CC, Shim V, Minami CA, Moore DH, Esserman LJ (2008) Estrogen receptor-negative breast cancer is less likely to arise among lipophilic statin users. Cancer Epidemiol Biomarkers Prev 17:1028–1033
Kumar-Sinha C, Tomlins SA, Chinnaiyan AM (2008) Recurrent gene fusions in prostate cancer. Nat Rev Cancer 8:497–511
Lam S, McWilliams A, LeRiche J, MacAulay C, Wattenberg L, Szabo E (2006) A phase I study of myo-inositol for lung cancer chemoprevention. Cancer Epidemiol Biomarkers Prev 15:1526–1531
Laxman B, Morris DS, Yu J, Siddiqui J, Cao J, Mehra R, Lonigro RJ, Tsodikov A, Wei JT, Tomlins SA, Chinnaiyan AM (2008) A first-generation multiplex biomarker analysis of urine for the early detection of prostate cancer. Cancer Res 68:645–649
Lewis CM, Cler LR, Bu DW, Zochbauer-Muller S, Milchgrub S, Naftalis EZ, Leitch AM, Minna JD, Euhus DM (2005) Promoter hypermethylation in benign breast epithelium in relation to predicted breast cancer risk. Clin Cancer Res 11:166–172
Li Y, Brown PH (2009) Prevention of ER-negative breast cancer. Recent Results Cancer Res 181:121–134
Lippman SM, Klein EA, Goodman PJ, Lucia MS, Thompson IM, Ford LG, Parnes HL, Minasian LM, Gaziano JM, Hartline JA, Parsons JK, Bearden JD III, Crawford ED, Goodman GE, Claudio J, Winquist E, Cook ED, Karp DD, Walther P, Lieber MM, Kristal AR, Darke AK, Arnold KB, Ganz PA, Santella RM, Albanes D, Taylor PR, Probstfield JL, Jagpal TJ, Crowley JJ, Meyskens FL Jr, Baker LH, Coltman CA Jr (2009) Effect of selenium and vitamin E on risk of prostate cancer and other cancers: the Selenium and Vitamin E Cancer Prevention Trial (SELECT). JAMA 301:39–51
Lucia MS, Epstein JI, Goodman PJ, Darke AK, Reuter VE, Civantos F, Tangen CM, Parnes HL, Lippman SM, La Rosa FG, Kattan MW, Crawford ED, Ford LG, Coltman CA Jr, Thompson IM (2007) Finasteride and high-grade prostate cancer in the Prostate Cancer Prevention Trial. J Natl Cancer Inst 99:1375–1383
Mandrekar SJ, Sargent DJ (2009) Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. J Clin Oncol 27:4027–4034
Meyskens FL Jr, Gerner EW (1999) Development of difluoromethylornithine (DFMO) as a chemoprevention agent. Clin Cancer Res 5:945–951
Meyskens FL Jr, McLaren CE, Pelot D, Fujikawa-Brooks S, Carpenter PM, Hawk E, Kelloff G, Lawson MJ, Kidao J, McCracken J, Albers CG, Ahnen DJ, Turgeon DK, Goldschmid S, Lance P, Hagedorn CH, Gillen DL, Gerner EW (2008) Difluoromethylornithine plus sulindac for the prevention of sporadic colorectal adenomas: a randomized placebo-controlled, double-blind trial. Cancer Prev Res 1:32–38
National Cancer Institute (2010) NIH State-of-the-Science Conference: Enhancing Use and Quality of Colorectal Cancer Screening. February 2–4, 2010, Bethesda, MD, 2010. http://consensus.nih.gov/2010/colorectalstatement.htm. Accessed February 26, 2010
Natrajan R, Weigelt B, Mackay A, Geyer FC, Grigoriadis A, Tan DS, Jones C, Lord CJ, Vatcheva R, Rodriguez-Pinilla SM, Palacios J, Ashworth A, Reis-Filho JS (2010) An integrative genomic and transcriptomic analysis reveals molecular pathways and networks regulated by copy number aberrations in basal-like, HER2 and luminal cancers. Breast Cancer Res Treat 121:575–89
NLST (2010) NLST: National Lung Screening Trial. National Cancer Institute, Jan 3, 2010. http://www.cancer.gov/nlst. Accessed February 26, 2010
Pepe MS, Etzioni R, Feng Z, Potter JD, Thompson ML, Thornquist M, Winget M, Yasui Y (2001) Phases of biomarker development for early detection of cancer. J Natl Cancer Inst 93:1054–1061
Pepe MS, Feng Z, Janes H, Bossuyt PM, Potter JD (2008) Pivotal evaluation of the accuracy of a biomarker used for classification or prediction: standards for study design. J Natl Cancer Inst 100:1432–1438
Polyak K (2009) Molecular markers for the diagnosis and management of ductal carcinoma in situ. NIH State-of-the-Science Conference: Diagnosis and Management of Ductal Carcinoma In Situ (DCIS). September 22–24, Bethesda, MD. NIH State-of-the-Science Conference: Diagnosis and Management of Ductal Carcinoma In Situ (DCIS), September 22–24, Bethesda, MD, 2009. http://consensus.nih.gov/2009/dcisstatement.htm. Accessed February 26, 2010
Qiu J, Choi G, Li L, Wang H, Pitteri SJ, Pereira-Faca SR, Krasnoselsky AL, Randolph TW, Omenn GS, Edelstein C, Barnett MJ, Thornquist MD, Goodman GE, Brenner DE, Feng Z, Hanash SM (2008) Occurrence of autoantibodies to annexin I, 14-3-3 theta and LAMR1 in prediagnostic lung cancer sera. J Clin Oncol 26:5060–5066
Ransohoff DF, Feinstein AR (1978) Problems of spectrum and bias in evaluating the efficacy of diagnostic tests. N Engl J Med 299:926–930
Ransohoff DF, Gourlay ML (2010) Sources of bias in specimens for research about molecular markers for cancer. J Clin Oncol 28:698–704
Ronnov-Jessen L, Bissell MJ (2009) Breast cancer by proxy: can the microenvironment be both the cause and consequence? Trends Mol Med 15:5–13
Sardana G, Dowell B, Diamandis EP (2008) Emerging biomarkers for the diagnosis and prognosis of prostate cancer. Clin Chem 54:1951–1960
Schatzkin A, Gail M (2002) The promise and peril of surrogate end points in cancer research. Nat Rev Cancer 2:19–27
Schatzkin A, Freedman LS, Schiffman MH, Dawsey SM (1990) Validation of intermediate end points in cancer research. J Natl Cancer Inst 82:1746–1752
Schroy PC III, Heeren TC (2005) Patient perceptions of stool-based DNA testing for colorectal cancer screening. Am J Prev Med 28:208–214
Sreekumar A, Poisson LM, Rajendiran TM, Khan AP, Cao Q, Yu J, Laxman B, Mehra R, Lonigro RJ, Li Y, Nyati MK, Ahsan A, Kalyana-Sundaram S, Han B, Cao X, Byun J, Omenn GS, Ghosh D, Pennathur S, Alexander DC, Berger A, Shuster JR, Wei JT, Varambally S, Beecher C, Chinnaiyan AM (2009) Metabolomic profiles delineate potential role for sarcosine in prostate cancer progression. Nature 457:910–914
Tan-Chiu E, Wang J, Costantino JP, Paik S, Butch C, Wickerham DL, Fisher B, Wolmark N (2003) Effects of tamoxifen on benign breast disease in women at high risk for breast cancer. J Natl Cancer Inst 95:302–307
Thompson IM, Goodman PJ, Tangen CM, Lucia MS, Miller GJ, Ford LG, Lieber MM, Cespedes RD, Atkins JN, Lippman SM, Carlin SM, Ryan A, Szczepanek CM, Crowley JJ, Coltman CA Jr (2003) The influence of finasteride on the development of prostate cancer. N Engl J Med 349:215–224
Thompson IM, Pauler DK, Goodman PJ, Tangen CM, Lucia MS, Parnes HL, Minasian LM, Ford LG, Lippman SM, Crawford ED, Crowley JJ, Coltman CA Jr (2004) Prevalence of prostate cancer among men with a prostate-specific antigen level < or =4.0 ng per milliliter. N Engl J Med 350:2239–2246
Tice JA, Cummings SR, Smith-Bindman R, Ichikawa L, Barlow WE, Kerlikowske K (2008) Using clinical factors and mammographic breast density to estimate breast cancer risk: development and validation of a new predictive model. Ann Intern Med 148:337–347
Tomlins SA, Rhodes DR, Perner S, Dhanasekaran SM, Mehra R, Sun XW, Varambally S, Cao X, Tchinda J, Kuefer R, Lee C, Montie JE, Shah RB, Pienta KJ, Rubin MA, Chinnaiyan AM (2005) Recurrent fusion of TMPRSS2 and ETS transcription factor genes in prostate cancer. Science 310:644–648
Tomlins SA, Rhodes DR, Yu J, Varambally S, Mehra R, Perner S, Demichelis F, Helgeson BE, Laxman B, Morris DS, Cao Q, Cao X, Andren O, Fall K, Johnson L, Wei JT, Shah RB, Al-Ahmadie H, Eastham JA, Eggener SE, Fine SW, Hotakainen K, Stenman UH, Tsodikov A, Gerald WL, Lilja H, Reuter VE, Kantoff PW, Scardino PT, Rubin MA, Bjartell AS, Chinnaiyan AM (2008) The role of SPINK1 in ETS rearrangement-negative prostate cancers. Cancer Cell 13:519–528
Vogel VG, Costantino JP, Wickerham DL, Cronin WM, Cecchini RS, Atkins JN, Bevers TB, Fehrenbacher L, Pajon ER, Wade JL 3rd, Robidoux A, Margolese RG, James J, Runowicz CD, Ganz PA, Reis SE, McCaskill-Stevens W, Ford LG, Jordan VC, Wolmark N. National Surgical Adjuvant Breast and Bowel Project (2010) Update of the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: Preventing breast cancer. Cancer Prev Res 3:696–706.
Vourlekis JS, Szabo E (2004) Use of markers for the detection and treatment of lung cancer. Dis Markers 20:71–85
Wagner JA (2002) Overview of biomarkers and surrogate endpoints in drug development. Dis Markers 18:41–46
Wang W, Srivastava S (2010) Strategic approach to validating methylated genes as biomarkers for breast cancer. Cancer Prev Res (Phila Pa) 3:16–24
Yang WT, Lewis MT, Hess K, Wong H, Tsimelzon A, Karadag N, Cairo M, Wei C, Meric-Bernstam F, Brown P, Arun B, Hortobagyi GN, Sahin A, Chang JC (2010) Decreased TGFbeta signaling and increased COX2 expression in high risk women with increased mammographic breast density. Breast Cancer Res Treat 119:305–314
zur Hausen H (2000) Papillomaviruses causing cancer: evasion from host-cell control in early events in carcinogenesis. J Natl Cancer Inst 92:690-698
Acknowledgements
The authors thank Darrell Anderson and Paul Wagner for sharing their insights on biomarkers during the writing of the manuscript. We also thank Lydia Kibiuk for providing graphics expertise in the design of Fig. 3.1.
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Dunn, B.K., Jegalian, K., Greenwald, P. (2010). Biomarkers for Early Detection and as Surrogate Endpoints in Cancer Prevention Trials: Issues and Opportunities. In: Senn, HJ., Otto, F. (eds) Clinical Cancer Prevention. Recent Results in Cancer Research, vol 188. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-10858-7_3
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