hpv dna test report_final pr

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Αξιολόγηση, χρήση, αποζημίωση και διάχυση των νέων τεχνικών προσυμπτωματικού ελέγχου του καρκίνου του τραχήλου της μήτρας* Αθήνα, Μάιος 2015

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  • , ,

    *

    , 2015

  • 2

    * , 20 2015, .

    :

    , - , (HPV) , , , M.D. (Thessaloniki), Dr Med (LMU Munich), FCOG (SA), - , , , . , MRCOG PhD, - , , , , , , (...). (.....), ... , , , . , , , - , , , Health Policy and Health Economics Manager, Roche Pharmaceuticals Hellas , ,

  • 3

    1 -

    , ,

    1. 2008, 529.800

    , 9%

    2, 2012 528.000

    266.000 1.

    HPV1,3,4 (Human PapillomaVirus),

    .

    (low-grade, LG) (high-

    grade, HG) (Cervical Intraepithelial Neoplasia -

    CIN), CIN1 CIN2/3 .

    , ,

    3,5.

    81.000

    2004, 16,5%

    (489.000) 34.000 , 463.000 DALYs (Disability

    Adjusted Life Years) 6.

    1 IARC International Agency for Research on Cancer (2005) IARC Handbooks of Cancer Prevention,

    Volume 10, Cervix Cancer Screening. Lyon, France 2 Jemal, A., Bray, F., Center, M.M., et al. (2011) Global cancer statistics. CA Cancer J Clin, 61:69-90

    3 IARC International Agency for Research on Cancer (2008) World Cancer Report 2008. Lyon, France

    4 Ylitalo, N., Stuver, S., Adami, H.O. (2008) Cervical Cancer. In: Adami HO, Hunter D, Trichopoulos D (eds),

    Textbook of Cancer Epidemiology, 2nd

    Edition. Oxford University Press, New York, pp.446-467 5 Wells, M., str, A.G., Crum, C.P., et al. (2003) Epithelial tumours. In: Tavassoli FA, Devilee P (eds),

    Pathology and Genetics of Tumours of the Breast and Female Genital Organs. IARC Press, Lyon, France, pp.259-279 6 WHO World Health Organization (2008) The global burden of disease: 2004 update. WHO Press,

    Switzerland

  • 4

    , 2004 480 280

    7. 2012,

    420 , 5 1.470

    210 8,9,

    .

    1,8, 5

    90-95% ,

    2.

    .

    2

    (ap test)

    HPV

    (HPV DNA test).

    2.1 ap testing

    1.

    7 Arbyn, M., Primic-Zakelj, M., Raifu, A.O., et al. (2007) The burden of cervical cancer in South-East Europe

    at the beginning of the 21st

    Century. Coll.Antropol., 31(2):7-10 8 IARC International Agency for Research on Cancer (2012). GLOBOCAN 2012: Estimated cancer

    incidence, mortality and prevalence worldwide in 2012. Available at http://globocan.iarc.fr/Pages/fact_sheets_population.aspx 9 Ferlay, J., Steliarova-Foucher, E., Lortet-Tieulent, J., et al. (2013) Cancer incidence and mortality patterns

    in Europe: estimates for 40 countries in 2012. European Journal of Cancer, 49:1374-1403

  • 5

    ,

    .

    2.2 HPV DNA testing

    HPV DNA test o

    1990, HPV

    .

    ,

    HPV DNA test

    , ,

    (~70%)

    16 18 3,10.

    3 ap test HPV DNA test

    ,

    HPV DNA test, ,

    .

    (primary screening)

    .

    10

    Chan, P.K.S., Picconi, M.A., Cheung, T.H., et al. (2012) Laboratory and clinical aspects of human papillomavirus testing. Critical Reviews in Clinical Laboratory Sciences; 49(4):117-136

  • 6

    3.1

    2

    : ,

    .

    , ,

    .

    ,

    ( ) ,

    (triage),

    ( -

    secondary screening).

    Pap test

    CIN2 (CIN2+) 44% 74%,

    53%, HPV DNA test ,

    100%11,12,13. , ap test 97%,

    HPV DNA test , 92%.

    . 2008,

    Cuzick et al.14 CIN2+ 1,

    11

    Whitlock, E.P., Vesco, K.K., Eder, M., et al. (2011) Liquid-based cytology and human papillomavirus testing to screen for cervical cancer: a systematic review for the U.S. Preventive Services Task Force. Ann Intern Med, 155(10):687-697 12

    Cuzick, J., Arbyn, M., Sankaranarayanan, R., et al. (2008) Overview of human papillomavirus-based and other novel options for cervical cancer screening in developed and developing countries. Vaccine, 26(10):29-41 13

    Agorastos, T., Chatzistamatiou, K., Katsamagkas, T., et al. (2015) Primary screening for cervical cancer based on High-Risk Human Papillomavirus (HPV) detection and HPV16 and HPV18 genotyping, in comparison to cytology. PLoS ONE, 10(3): e0119755. doi:10.1371/journal. pone.0119755 14

    Cuzick, J., Szarewski, A., Mesher, D., et al. (2008) Long-term follow-up of cervical abnormalities among women screened by HPV testing and cytology results from the Hammersmith study. Int J Cancer; 122:2294-2300

  • 7

    5 9 0,33%, 0,83%

    2,20% , HPV DNA test

    CIN2+ 0,19%, 0,42% 1,88% .

    HPV DNA test

    CIN2+ 6 ,

    3 .

    , 2

    CIN3+ 15,

    HPV DNA test,

    CIN3+

    ap test HPV DNA

    test.

    ,

    (...)16,

    ap test 3-5

    , HPV DNA test 5

    .

    ,

    ATHENA13,17,

    ap test, HPV DNA test,

    2

    .

    (DNA) HPV ,

    12

    HPV (hrHPV) , 15

    Huh, W., Ault, K.A., Chelmow, D., et al. (2015) Use of primary high-risk human papillomavirus testing for cervical cancer screening: Interim clinical guidance. Gynecol Oncol, http://dx.doi.org/10.1016/j.ygyno.2014.12.022 16

    WHO World Health Organization (2013) WHO Guidelines for screening and treatment of precancerous lesions for cervical cancer prevention. WHO Publications, South Africa 17

    Castle, P.E., Stoler, M.H., Wright, T.C., et al. (2011) Performance of carcinogenic human papillomavirus (HPV) testing and HPV16 or HPV18 genotyping for cervical cancer screening in women aged 25 years and older: a subanalysis of the ATHENA study. The Lancet Oncology; 12(9):880-890

  • 8

    2

    , 16 18.

    ( 1),

    , CIN2+

    HPV DNA Test 14 hrHPV , 13

    HPV16,

    CIN2+, .

    , ATHENA trial

    HPV DNA Test 38,7% ap test

    (92% 53,3% ) CIN3+, 2

    (co-testing) 96,7%.

    , 16 18

    HPV DNA test 59,5%,

    ap test, 3 (positive

    predictive value), .

  • 9

    ,

    (HEllenic Real life Multicentric cErvical Screening, HERMES),

    HPV DNA test CIN2+

    100%, ap test 53,7%13.

    3.2

    H

    .

    (Quality Adjusted Life Years).

    HPV DNA test ,

    (

    )

    .

    , , HPV DNA test

    (

    )

    18,19. Vijayaraghavan et al19,

    HPV DNA test

    3 30

    ( )

    .

    3

    18

    Holmes, J., Hemmett, L., Garfield, S. (2005) The cost-effectiveness of human papillomavirus screening for cervical cancer. The European Journal of Health Economics; 6(1):30-37 19

    Vijayaraghavan, A., Efrusy, M.B., Mayrand, M.H., et al. (2010) Cost-effectiveness of high-risk human papillomavirus testing for cervical cancer screening in Qubec, Canada. Can J Public Health; 101(3):220-225

  • 10

    HPV DNA test

    .

    Rosmalen et al.20,

    HPV DNA test

    HPV DNA test

    .

    , ATHENA trial21

    HPV DNA test

    ,

    HPV DNA test

    (co-testing)

    .

    4

    ,

    ,

    .

    ,

    ,

    20

    Van Rosmalen, J., de Kok, I.M., van Ballegooijen, M. (2012) Cost-effectiveness of cervical cancer screening: cytology versus human papillomavirus DNA testing. BJOG; 119(6):699-709 21

    Huh, W.K., Williams, E., Huang, J., Bramley, T., Poulios, N. (2014)Cost Effectiveness of Human Papillomavirus-16/18 Genotyping in Cervical Cancer Screening. Appl Health Econ Health Policy DOI 10.1007/s40258-014-0135-4

  • 11

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  • 12

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    (QALYs) . ,

    HPV DNA test 16/18

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    ,

    , (

    30,3%)22,

    . , ,

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    ,

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    22

    Agorastos T, Chatzistamatiou K, Zafrakas M, Siamanta V, Katsamagkas T, Constantinidis TC,

    Lampropoulos AF; LYSISTRATA study group (2014). Epidemiology of HPV infection and current status

    of cervical cancer prevention in Greece: final results of the LYSISTRATA cross-sectional study.Eur J

    Cancer Prev.23(5):425-31

  • 13

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    IARC - International Agency for Research on Cancer (2008) European guidelines for quality assurance in cervical cancer screening - 2

    nd edition. European Communities, Belgium

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