HE4 as an Early Detection Biomarker of Epithelial Ovarian Cancer: Investigations in Prediagnostic Specimens from the Janus Serumbank

International Journal of Gynecological Cancer

Volumn 25, Issue 9, 2015, Pages 1608-1615

  Gislefoss, Randi Elin ^a   Langseth, Hilde ^a   Bolstad, Nils ^a   Nustad, Kjell ^b   Mørkrid, Lars ^a  

^a CANCER REGISTRY OF NORWAY   (Norway)

^b OSLO UNIVERSITY HOSPITAL   (Norway)

Author keywords

Biobank; Early detection; HE4, CA125; Ovarian cancer; Tumor marker

Indexed keywords

CA 125 ANTIGEN; COTININE; HUMAN EPIDIDYMIS PROTEIN 4; PROTEIN; WFDC2 PROTEIN, HUMAN;

ABSORPTION LAG TIME; ADULT; AGE DISTRIBUTION; ARTICLE; BLOOD ANALYSIS; BLOOD SAMPLING; CANCER DIAGNOSIS; CLINICAL ASSESSMENT; CLINICAL EVALUATION; COMPARATIVE STUDY; CONTROLLED STUDY; FEMALE; HUMAN; MAJOR CLINICAL STUDY; OVARY CARCINOMA; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; SMOKING; BIOBANK; BLOOD; CASE CONTROL STUDY; EARLY CANCER DIAGNOSIS; METABOLISM; MIDDLE AGED; NEOPLASMS, GLANDULAR AND EPITHELIAL; NORWAY; OVARIAN NEOPLASMS; PROCEDURES; TIME FACTOR;

BIOLOGICAL SPECIMEN BANKS; CA-125 ANTIGEN; CASE-CONTROL STUDIES; COTININE; EARLY DETECTION OF CANCER; FEMALE; HUMANS; MIDDLE AGED; NEOPLASMS, GLANDULAR AND EPITHELIAL; NORWAY; OVARIAN NEOPLASMS; PROTEINS; SMOKING; TIME FACTORS;

EID: 84946023474     PISSN: 1048891X     EISSN: 15251438     Source Type: Journal    
DOI: 10.1097/IGC.0000000000000532     Document Type: Article

References (52)

1. Bray F, Loos AH, Tognazzo S, et al. Ovarian cancer in Europe: cross-sectional trends in incidence and mortality in 28 countries, 1953-2000. Int J Cancer. 2005;113:977-990.
2. Cancer in Norway 2012-Cancer incidence, mortality, survival and prevalence in Norway. Oslo: Cancer Registry of Norway; 2014.
3. Jacobs IJ, Menon U. Progress and challenges in screening for early detection of ovarian cancer. Mol Cell Proteomics. 2004;3:355-366.
4. King MC, Marks JH, Mandell JB, et al. Breast and ovarian cancer risks due to inherited mutations in BRCA1 and BRCA2. Science. 2003;302:643-646.
5. Ovarian cancer; causes, risk factors, and prevention topics Available at: http://www.cancer.org/cancer/ovariancancer/detailedguide/ovarian-cancer-risk-factors. Accessed July 9, 2015.
6. Luvero D, Milani A, Ledermann JA. Treatment options in recurrent ovarian cancer: latest evidence and clinical potential. Ther Adv Med Oncol. 2014;6:229-239.
7. Urban N. Screening for ovarian cancer.We now need a definitive randomised trial. BMJ. 1999;319:1317-1318.
8. Yin BW, Dnistrian A, Lloyd KO. Ovarian cancer antigen CA125 is encoded by the MUC16 mucin gene. Int J Cancer. 2002;98:737-740.
9. Bast RC Jr. Status of tumor markers in ovarian cancer screening. J Clin Oncol. 2003;21:200sY205s.
10. Bast RC Jr, Klug TL, St John E, et al. A radioimmunoassay using a monoclonal antibody to monitor the course of epithelial ovarian cancer. N Engl J Med. 1983;309:883-887.
11. Makar AP, Kristensen GB, Kaern J, et al. Prognostic value of pre-and postoperative serum CA 125 levels in ovarian cancer: new aspects and multivariate analysis. Obstet Gynecol. 1992;79:1002-1010.
12. Brumsted JR, McBean JH, Deaton JL, et al. CA-125 secretion by luteal phase endometrium in vitro. Hum Reprod. 1990;5:682-684.
13. Sarandakou A, Protonotariou E, Rizos D. Tumor markers in biological fluids associated with pregnancy. Crit Rev Clin Lab Sci. 2007;44:151-178.
14. Bagan P, Berna P, Assouad J, et al. Value of cancer antigen 125 for diagnosis of pleural endometriosis in females with recurrent pneumothorax. Eur Respir J. 2008;31:140-142.
15. Markman M. The role of CA-125 in the management of ovarian cancer. Oncologist. 1997;2:6-9.
16. Drapkin R, von Horsten HH, Lin Y, et al. Human epididymis protein 4 (HE4) is a secreted glycoprotein that is overexpressed by serous and endometrioid ovarian carcinomas. Cancer Res. 2005;65:2162-2169.
17. Moore RG, Brown AK, Miller MC, et al. The use of multiple novel tumor biomarkers for the detection of ovarian carcinoma in patients with a pelvic mass. Gynecol Oncol. 2008;108:402-408.
18. Kirchhoff C, Habben I, Ivell R, et al. A major human epididymisYspecific cDNA encodes a protein with sequence homology to extracellular proteinase inhibitors. Biol Reprod. 1991;45:350-357.
19. Galgano MT, Hampton GM, Frierson HF Jr. Comprehensive analysis of HE4 expression in normal and malignant human tissues. Mod Pathol. 2006;19:847-853.
20. Hough CD, Sherman-Baust CA, Pizer ES, et al. Large-scale serial analysis of gene expression reveals genes differentially expressed in ovarian cancer. Cancer Res. 2000;60: 6281-6287.
21. Schummer M, Ng WV, Bumgarner RE, et al. Comparative hybridization of an array of 21,500 ovarian cDNAs for the discovery of genes overexpressed in ovarian carcinomas. Gene. 1999;238:375-385.
22. Bolstad N, Øijordsbakken M, Nustad K, et al. Human epididymis protein 4 reference limits and natural variation in a Nordic reference population. Tumour Biol. 2012;33: 141-148.
23. Cramer DW, Bast RC Jr, Berg CD, et al. Ovarian cancer biomarker performance in prostate, lung, colorectal, and ovarian cancer screening trial specimens. Cancer Prev Res (Phila). 2011;4:365-374.
24. Urban N, Thorpe JD, Bergan LA, et al. Potential role of HE4 in multimodal screening for epithelial ovarian cancer. J Natl Cancer Inst. 2011;103:1630-1634.
25. H L, RE G, JI M, et al. The Janus Serum BankVFrom Sample Collection to Cancer Research. Oslo: Cancer Registry of Norway; 2010.
26. Gislefoss RE, Grimsrud TK, Mørkrid L. Long-term stability of serum components in the Janus Serum Bank. Scand J Clin Lab Invest. 2008;68:402-409.
27. Gislefoss RE, Grimsrud TK, Mørkrid L. Stability of selected serum proteins after long-term storage in the Janus Serum Bank. Clin Chem Lab Med. 2009;47:596-603.
28. Gislefoss RE, Grimsrud TK, Høie K, et al. Stability of testosterone measured in male archival serum samples by 2 different methods. Scand J Clin Lab Invest. 2012;72: 555-562.
29. Larsen IK, Smastuen M, Johannesen TB, et al. Data quality at the Cancer Registry of Norway: an overview of comparability, completeness, validity and timeliness. Eur J Cancer. 2009;45:1218-1231.
30. Parkin DM, Bray F. Evaluation of data quality in the cancer registry: principles and methods. Part II. Completeness. Eur J Cancer. 2009;45:756-764.
31. Tingulstad S, Halvorsen T, Norstein J, et al. Completeness and accuracy of registration of ovarian cancer in the cancer registry of Norway. Int J Cancer. 2002;98:907-911.
32. Jarvis MJ, Tunstall-Pedoe H, Feyerabend C, et al. Comparison of tests used to distinguish smokers from nonsmokers. Am J Public Health. 1987;77:1435-1438.
33. Nustad K, Bast RC Jr, Brien TJ, et al. Specificity and affinity of 26 monoclonal antibodies against the CA 125 antigen: first report from the ISOBM TD-1 workshop. International Society for Oncodevelopmental Biology and Medicine. Tumour Biol. 1996;17:196-219.
34. Midttun Ø, Hustad S, Ueland PM. Quantitative profiling of biomarkers related to B-vitamin status, tryptophan metabolism and inflammation in human plasma by liquid chromatography/tandem mass spectrometry. Rapid Commun Mass Spectrom. 2009;23:1371-1379.
35. Ueland PM, Midttun O, Windelberg A, et al. Quantitative profiling of folate and one-carbon metabolism in large-scale epidemiological studies by mass spectrometry. Clin Chem Lab Med. 2007;45:1737-1745.
36. IBM Corp. Released 2010. IBM SPSS Statistics for Windows. New York: IBM Corp.
37. Anderson GL, McIntosh M, Wu L, et al. Assessing lead time of selected ovarian cancer biomarkers: A nested case-control study. J Natl Cancer Inst. 2010;102:26-38.
38. Urban N. Designing early detection programs for ovarian cancer. Ann Oncol. 2011;22:viii6Yviii18.
39. Bast RC Jr, Siegal FP, Runowicz C, et al. Elevation of serum CA 125 prior to diagnosis of an epithelial ovarian carcinoma. Gynecol Oncol. 1985;22:115-120.
40. Helzlsouer KJ, Bush TL, Alberg AJ, et al. Prospective study of serum CA-125 levels as markers of ovarian cancer. JAMA. 1993;269:1123-1126.
41. Zurawski VR Jr, Orjaseter H, Andersen A, et al. Elevated serum CA 125 levels prior to diagnosis of ovarian neoplasia: relevance for early detection of ovarian cancer. Int J Cancer. 1988;42:677-680.
42. Bjørge T, Lie AK, Hovig E, et al. BRCA1 mutations in ovarian cancer and borderline tumours in Norway: A nested case-control study. Br J Cancer. 2004;91:1829-1834.
43. Azzam AZ, Hashad DI, Kamel NA. Evaluation of HE4 as an extrabiomarker to CA125 to improve detection of ovarian carcinoma: is it time for a step forward? Arch Gynecol Obstet. 2013;288:167-172.
44. Pauler DK, Menon U, McIntosh M, et al. Factors influencing serum CA125II levels in healthy postmenopausal women. Cancer Epidemiol Biomarkers Prev. 2001;10:489-493.
45. Hallamaa M, Suvitie P, Huhtinen K, et al. Serum HE4 concentration is not dependent on menstrual cycle or hormonal treatment among endometriosis patients and healthy premenopausal women. Gynecol Oncol. 2012;125:667-672.
46. Grover S, Koh H,Weideman P, et al. The effect of the menstrual cycle on serum CA 125 levels: A population study. Am J Obstet Gynecol. 1992;167:1379-1381.
47. Langseth H, Luostarinen T, Bray F, et al. Ensuring quality in studies linking cancer registries and biobanks. Acta Oncol. 2010;49:368-377.
48. Rundle AG, Vineis P, Ahsan H. Design options for molecular epidemiology research within cohort studies. Cancer Epidemiol Biomarkers Prev. 2005;14:1899-1907.
49. Ferraro S, Braga F, Lanzoni M, et al. Serum human epididymis protein 4 vs carbohydrate antigen 125 for ovarian cancer diagnosis: A systematic review. J Clin Pathol. 2013;66:273-281.
50. Montagnana M, Lippi G, Ruzzenente O, et al. The utility of serum human epididymis protein 4 (HE4) in patients with a pelvic mass. J Clin Lab Anal. 2009;23:331-335.
51. Havrilesky LJ, Whitehead CM, Rubatt JM, et al. Evaluation of biomarker panels for early stage ovarian cancer detection and monitoring for disease recurrence. Gynecol Oncol. 2008;110:374-382.
52. Anastasi E1, Granato T, Marchei GG, et al. Ovarian tumor marker HE4 is differently expressed during the phases of the menstrual cycle in healthy young women. Tumour Biol. 2010;31:411-415. doi: 10.1007/s13277-010-0049-1. Epub 2010 May 20.