Role of E6/E7 mRNA test in the diagnostic algorithm of HPV-positive patients showing ASCUS and LSIL: Clinical and economic implications in a publicly financed healthcare system

Expert Review of Molecular Diagnostics

Volumn 15, Issue 1, 2015, Pages 137-150

  Zappacosta, Roberta ^a,b   Gatta, Daniela Maria Pia ^a   Marinucci, Pierluigi ^a   Capanna, Serena ^a   Lattanzio, Giuseppe ^b   Caraceni, Donatella ^c   Rosini, Sandra ^a  

^a UNIVERSITY OF CHIETI   (Italy)

^b ANNUNZIATA HOSPITAL   (Italy)

^c F Renzetti Hospital   (Italy)

Author keywords

cost effectiveness analysis; E6 E7 HPV mRNA test; human papillomavirus; ICER; persistent HPV infections; Triage test; triage test

Indexed keywords

PROTEIN E6; PROTEIN E7; VIRUS MESSENGER RNA; MESSENGER RNA;

ADULT; ALGORITHM; ARTICLE; ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE; CANCER SCREENING; COLPOSCOPY; COST EFFECTIVENESS ANALYSIS; DNA DETERMINATION; FEMALE; HEALTH CARE COST; HEALTH CARE POLICY; HEALTH CARE SYSTEM; HEALTH ECONOMICS; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; NONHUMAN; PAPILLOMAVIRUS INFECTION; PATIENT REFERRAL; SQUAMOUS CELL CARCINOMA; SQUAMOUS INTRAEPITHELIAL LESION OF THE CERVIX; UTERINE CERVIX CYTOLOGY; COST BENEFIT ANALYSIS; EARLY DIAGNOSIS; ECONOMICS; GENETICS; MIDDLE AGED; MOLECULAR DIAGNOSIS; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS INFECTIONS; SQUAMOUS INTRAEPITHELIAL LESIONS OF THE CERVIX; UTERINE CERVICAL NEOPLASMS; UTERINE CERVIX DYSPLASIA; VIROLOGY;

ADULT; ATYPICAL SQUAMOUS CELLS OF THE CERVIX; COLPOSCOPY; COST-BENEFIT ANALYSIS; EARLY DETECTION OF CANCER; FEMALE; HUMANS; MIDDLE AGED; MOLECULAR DIAGNOSTIC TECHNIQUES; PAPILLOMAVIRIDAE; PAPILLOMAVIRUS E7 PROTEINS; PAPILLOMAVIRUS INFECTIONS; RNA, MESSENGER; SQUAMOUS INTRAEPITHELIAL LESIONS OF THE CERVIX; UTERINE CERVICAL NEOPLASMS;

EID: 84919913635     PISSN: 14737159     EISSN: 17448352     Source Type: Journal    
DOI: 10.1586/14737159.2015.961915     Document Type: Article

References (69)

1. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin 2012;62: 10-29
2. Arbyn M, Castellsague X, de Sanjosé S, et al. Worldwide burden of cervical cancer in 2008. Ann Oncol 2011;22:2675-86
3. zur Hausen H. The search for infectious causes of human cancers: where and why (Nobel lecture). Angew Chem Int Ed Engl 2009;48:5798-808
4. Kjær SK, Frederiksen K, Munk C, Iftner T. Long-term absolute risk of cervical intraepithelial neoplasia grade 3 or worse following human papillomavirus infection: role of persistence. J Natl cancer Inst 2010;102:1478-88
5. zur Hausen H. Human papillomavirus & cervical cancer. Indian J Med Res 2009;130: 209-15
6. American Congress of Obstetricians and Gynecologists (ACOG). Practice Bulletin No. 131: screening for cervical cancer. Obstet Gynecol 2012;120:1222-38
7. NHSCSP audit of invasive cervical cancer. National report 2007-2010. Available from: www.cancerscreening.nhs.uk/cervical/publications/nhscsp-audit-invasive-cervicalcancer-201107.pdf [Last accessed 9 June 2014]
8. Gage JC, Schiffman M, Solomon D, et al. Risk of precancer determined by HPV genotype combinations in women with minor cytologic abnormalities. Cancer Epidemiol Biomarkers Prev 2013;22: 1095-101
9. Kinney WK, Manos MM, Hurley LB, Ransley JE. Where's the high-grade cervical neoplasia? The importance of minimally abnormal Papanicolaou diagnoses. Obstet Gynecol 1998;91:73-6
10. Centers for Disease Control and prevention. Available from: www.cdc.gov/std/stats/stiestimates-fact-sheet-feb-2013.pdf [Last accessed 26 May 2014]
11. Killeen JL, Dye T, Grace C, Hiraoka M. Improved abnormal pap smear triage using cervical cancer biomarkers. J Low Genit Tract Dis 2014;18:1-7
12. Monsonego J, Bosch FX, Coursaget P. Cervical cancer control, priorities and new directions. Int J Cancer 2004;108:329-33
13. ASCUS-LSIL Triage Study (ALTS) group. A randomized trial on the management of cytology interpretation of atypical squamous cells of undetermined significance. Am J Obstet Gynecol 2003;188:1383-92
14. ASCUS-LSIL Triage Study (ALTS) group. A randomized trial on the management of low-grade squamous intraepithelial lesion cytology interpretation. Am J Obstet Gynecol 2003;188:1393-400
15. Basu P, Samaddar A, Mittal S, et al. Concordance between hybrid capture 2 results performed on cervical samples obtained before and immediately after visual inspection with acetic acid test. Int J Prev Med 2014;5:191-5
16. Solomon D. Role of triage testing in cervical cancer screening. J Natl Cancer Inst Monogr 2003;1:97-101
17. Verdoodt F, Szarewski A, Halfon P, et al. Triage of women with minor abnormal cervical cytology. Cancer Cytopathol 2013;121:675-87
18. Cuzick J, Arbyn M, Sankaranarayanan R, et al. Overview of human papillomavirus-based and other novel options for cervical cancer screening in developed and developing countries. Vaccine 2008;26:29-41
19. Jakobsson M, Tarkkanen J, Auvinen E, et al. Colposcopy referral rate can be reduced by high-risk human Papillomavirus triage in the management of recurrent atypical squamous cells of undetermined significance or low-grade squamous intraepithelial lesion cytology in Finland. Int J STD AIDS 2012;23:485-9
20. ACOG Practice Bulletin: clinical management guidelines for obstetriciangynecologists. Cervical cytology screening. Number 45, August 2003. Obstet Gynecol 2003;102:417-27
21. Ronco G, Biggeri A. Confortini M, et al. health technology assessment report: HPV-DNA based primary screening for cervical cancer precursor. Epidemiol Prev 2012;36:1-72
22. Knoff J, Yang B, Hung CF, Wu TC. Cervical cancer: development of targeted therapies beyond molecular pathogenesis. Curr Obstet Gynecol Rep 2014;3:18-32
23. Tornesello ML, Buonaguro L, Giorgi-Rossi P, Buonaguro FM. Viral and cellular biomarkers in the diagnosis of cervical intraepithelial neoplasia and cancer. Biomed Res Int 2013;2013:519-619
24. Cherry JJ, Rietz A, Malinkevich A, et al. Structure based identification and characterization of flavonoids that disrupt human papillomavirus-16 E6 function. PLoS One 2013;8:3-17
25. Nor Rashid N, Yusof R, Watson RJ. Disruption of pocket protein dream complexes by E7 proteins of different types of human papillomaviruses. Acta Virol 2013;57:447-51
26. Park JW, Shin MK, Pitot HC, Lambert PF. High incidence of HPV-associated head and neck cancers in FA deficient mice is associated with E7's induction of DNA damage through its inactivation of pocket proteins. PLoS One 2013;8(9):11-18
27. Park JW, Shin MK, Lambert PF. High incidence of female reproductive tract cancers in FA-deficient HPV16-transgenic mice correlates with E7's induction of DNA damage response, an activity mediated by E7's inactivation of pocket proteins. Oncogene 2013;9:54-67
28. Kraus I, Molden T, Holm R, et al. Presence of E6 and E7 mRNA from human Papillomavirus types 16, 18, 31, 33, and 45 in the majority of cervical carcinomas. J Clin Microbiol 2006;44:1310-17
29. Guess JC, McCance DJ. Decreased migration of Langerhans precursor-like cells in response to human keratinocytes expressing human papillomavirus type 16 E6/E7 is related to reduced macrophage inflammatory protein-3 production. Virol 2005;79: 14852-7
30. Biswas SK, Sodhi A. Effect of monocyte chemoattractant protein-1 on murine bone marrow cells: proliferation, colony-forming ability and signal transduction pathway involved. Int J Immunopathol Pharmacol 2002;15:183-7
31. Scott M, Nakagawa M, Moscicki A. Cell-mediated immune response to human papillomavirus infection. Clin Diagn Lab Immunol 2001;8:209-13
32. Doorbar J. The Papillomavirus life cycle. J Clin Virol 2005;32S:S7-S15
33. Denton KJ, Bergeron C, Klement P, et al. European CINtec Cytology Study Group. The sensitivity and specificity of p16 (INK4a) cytology vs HPV testing for detecting high-grade cervical disease in the triage of ASC-US and LSIL pap cytology results. Am J Clin Pathol 2010;134:12-21
34. Dockter J, Schroder A, Earon B, et al. Analytical characterization of the APTIMA HPV assay. J Clin Virol 2009;45: 39-47
35. Narimatsu R, Patterson BK. High-throughput cervical cancer screening with using intracellular human Papillomavirus E6 and E7 mRNA quantification by flow cytometry. Am J Clin Pathol 2005;123:716-23
36. Shen Y, Gong J, He Y, et al. Quantivirus HPV E6/E7 RNA 3.0 assay (bDNA) is as sensitive, but less specific than Hybrid Capture 2 test. J Virol Methods 2012;187: 288-93
37. Burger EA, Kornør H, Klemp M, et al. HPV mRNA tests for the detection of cervical intraepithelial neoplasia: a systematic review. Gynecol Oncol 2011;120:430-8
38. Cuschieri KS, Whitley MJ, Cubie HA. Human Papillomavirus type specific DNA and RNA persistence-implications for cervical disease progression and monitoring. J Med Virol 2004;73:65-70
39. Molden T, Nygård JF, Kraus I, et al. Predicting CIN2+ when detecting HPV mRNA and DNA by PreTect HPV-proofer and consensus PCR: a 2-year follow-up of women with ASCUS or LSIL Pap smear. Int J Cancer 2005;10:973-7
40. Benevolo M, Vocaturo A, Caraceni D, et al. Sensitivity, specificity, and clinical value of human papillomavirus (HPV) E6/E7 mRNA assay as a triage test for cervical cytology and HPV DNA test. J Clin Microbiol 2011;49:2643-50
41. Coleman D, Day N, Douglas G, et al. European guidelines for quality assurance in cervical cancer screening. Eur J Cancer 1993;29(4):1-38
42. Osservatorio Nazionale Screening. Available from: www.osservatorionazionalescreening.it [Last accessed 7 March 2014]
43. Mennini FS, Costa S, Favato G, Picardo M. Anti-HPV vaccination: a review of recent economic data for Italy. Vaccine 2009;27: 54-61
44. Baio G, Capone A, Marcellini A, et al. Economic burden of human papilloma virus related disease. PLoS One 2012;7:1-9
45. Arbyn M, Ronco G, Cuzich J, et al. How to evaluate emerging technologies in cervical cancer screening? Int J Cancer 2009;125: 2489-96
46. WHO. Immunization financing, supply and procurement. Posted by WHO, Geneva, Switzerland, 3 February 2006 Available from: www.who.int/immunization.supply/en/[ Last accessed 7 March 2014]
47. Jordan J, Arbyn M, Hirsch PM, et al. European guidelines for quality assurance in cervical cancer screening: recommendations for clinical management of abnormal cervical cytology. Cytopathol 2008;19: 342-54
48. Guidelines of the Italian Society of Cervical Pathology and Colposcopy (SICPVCP). Available from: www.colposcopiaitaliana.it/pdf07/Linee-Guida-2006.pdf [Last accessed 7 March 2014]
49. Guidelines of the Italian Society for Gynaecology and Obstetrics (SIGO). Available from: www.sigo.it/linee-guida-sigo/linee-guida-internazionali.php [Last accessed 7 March 2014]
50. Ostensson E, Froberg M, Hjerpe A, et al. Economic analysis of human papillomavirus triage, repeat cytology, and immediate colposcopy in management of women with minor cytological abnormalities in Sweden. Acta Obstetricia et Gynecologica 2010;89: 1316-25
51. Volante R, Ronco G. National survey on the quality of the second level screening for cervical cancer. Epidemiol Prev 2006;30: 49-55
52. Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics 1977;1:159-74
53. Drumond MF, Sculpher MJ, Torrance GW, et al. Methods for the economic evaluation of health care programmes. Oxford University Press; New York, NY, USA: 2005
54. Gold MR, Siegel JE, Russel LB, et al. Cost-effectiveness in health and medicine. Oxford University Press; New York, NY, USA: 1996
55. Official 2013 National Italian Tariff Formularies. Available from: www.salute. gov.it [Last accessed 7 March 2014]
56. Giorgi-Rossi P, Ricciardi A, Cohet C, et al. Epidemiology and costs of cervical cancer screening and cervical dysplasia in Italy. BMC Public Health 2009;9:1-9
57. Armarnik S, Sheiner E, Piura B, et al. Obstetric outcome following cervical conisation. Arch Gynecol Obstet 2011;283: 765-9
58. Zappacosta R, Rosini S. Cervical cancer screening: from molecular basis to diagnostic practice, going through new technologies. Tech Cancer Res Treat 2008;7:1-14
59. Ferris DG, Litaker MS; ASCUS/LSIL Triage Study (ALTS) Group. Colposcopy quality control by remote review of digitized colposcopic images. Am J Obstet Gynecol 2004;191:1934-41
60. Szarewski A, Mesher D, Cadman L, et al. A comparison of 7 tests for high grade cervical intraepithelial neoplasia in women with abnormal smears: the Predictors 2 study. J Clin Microbiol 2012;50:1867-73
61. Ratnan S, Coutlee F, Fontaine D, et al. Clinical performances of the PreTect HPV Proofer E6/E7 mRNA assay in comparison with that of the Hybrid Capture 2 test for identification of women at high risk of cervical cancer. J Clin Microbiol 2010;48: 2779-85
62. Monsonego J. Emerging issues on HPV infections from science to practice. Karger; Paris, UK: 2006 pp 82-102.
63. Kim JJ, Wright TC, Goldie SJ. Cost-effectiveness of alternative triage strategies for atypical squamous cell of undetermined significance. JAMA 2002;287: 2382-90
64. S Kamperle M, Kocjan BJ, Maver PJ, et al. Human papillomavirus (HPV) prevalence and HPV type distribution in cervical, vulvar, and anal cancers in central and eastern Europe. Acta Dermatovenerol Alp pannonica Adriat 2013;22(1):1-5
65. Pinkerton SD, Johnson-Masotti AP, Derse A, Layde PM. Ethical issues in cost-effectiveness analysis. Eval Program Plann 2002;25:71-83
66. Psyrri A, Di Maio D. Human papillomavirus in cervical and head and neck cancer. Nat Clin Prac Oncol 2008;5: 24-31
67. Welters MJ, Kenter G, Piersma SJ, et al. Induction of tumor-specific CD4+ and CD8+ T-cell immunity in cervical cancer patients by a human papillomavirus type 16 E6 and E7 long peptides vaccine. Clin Cancer Res 2008;14:178-87
68. Wentzensen N, Sherman ME, Schiffman M, et al. Utility of methylation markers in cervical cancer early detection: appraisal of the state-of-the-science. Gynecol Oncol 2009;112:293-9
69. Benevolo M, Terrenato I, Mottolese M, et al. Diagnostic and prognostic validity of the human papillomavirus E6/E7 mRNA test in cervical cytological samples of HC2-positive patients. Cancer Causes Control 2011;22:869-75