Advertisement

The ATHENA human papillomavirus study: design, methods, and baseline results

      Objective

      The objective of the study was to describe baseline data from Addressing the Need for Advanced HPV Diagnostics, a prospective, multicenter US cervical cancer screening trial.

      Study Design

      A total of 47,208 women aged 21 years or older undergoing routine screening were enrolled; liquid-based cytology and human papillomavirus (HPV) testing were performed. Women with abnormal cytology underwent colposcopy, as did high-risk HPV (hrHPV)–positive women and a random subset of women negative by both tests aged 25 years or older. Verification bias adjustment was applied; 95% confidence intervals were computed by the bootstrap method.

      Results

      The prevalence of cytologic abnormalities was 7.1%. hrHPV, HPV 16, and HPV 18 were detected using the cobas HPV Test in 12.6%, 2.8%, and 1.0% of women, respectively. Both cytologic abnormalities and hrHPV positivity declined with increasing age. The adjusted prevalence of cervical intraepithelial neoplasia grade 2 (CIN2) or greater in women aged 25-34 years was 2.3%, decreasing to 1.5% among older women.

      Conclusion

      The Addressing the Need for Advanced HPV Diagnostics study provides important estimates of the prevalence of cytologic abnormalities, hrHPV positivity, and CIN2 or greater in a US screening population.

      Key words

      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic and Personal
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to American Journal of Obstetrics & Gynecology
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Kurman R.J.
        • Ellenson L.H.
        • Ronnett B.M.
        Blaustein's pathology of the female genital tract.
        Springer, New York, NY2002
        • Altekruse S.F.
        • Kosary C.L.
        • Krapcho M.
        • et al.
        SEER cancer statistics review, 1975-2007.
        National Cancer Institute, Bethesda, MD2009
        • American Cancer Society
        What are the key statistics about cervical cancer?.
        (Accessed March 13, 2010)
        • Wright Jr, T.C.
        • Massad L.S.
        • Dunton C.J.
        • Spitzer M.
        • Wilkinson E.J.
        • Solomon D.
        2006 consensus guidelines for the management of women with cervical intraepithelial neoplasia or adenocarcinoma in situ.
        J Low Genit Tract Dis. 2007; 11: 223-239
        • de Sanjose S.
        • Quint W.G.
        • Alemany L.
        • et al.
        Human papillomavirus genotype attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study.
        Lancet Oncol. 2010; 11: 1048-1056
      1. Cervista HPV HR test instructions for use.
        Third Wave Technologies, Inc, Madison, WI2009
      2. hc2 High-Risk HPV DNA Test [package insert].
        Digene Corp, Gaithersburg, MD2007
        • ALTS Group
        Results of a randomized trial on the management of cytology interpretations of atypical squamous cells of undetermined significance.
        Am J Obstet Gynecol. 2003; 188: 1383-1392
        • Stoler M.H.
        • Wright Jr, T.C.
        • Sharma A.
        • Apple R.
        • Gutekunst K.
        • Wright T.L.
        High-risk human papillomavirus testing in women with ASC-US cytology: results from the ATHENA HPV study.
        Am J Clin Pathol. 2011; 135: 468-475
        • Zhou X.H.
        • Obuchowski N.A.
        • Obuchowski D.M.
        Statistical methods in diagnostic medicine.
        John Wiley and Sons, New York, NY2002
        • Chernick M.
        Bootstrapping methods: a practitioner's guide.
        Wiley Interscience, New York1998 (8 and 112)
        • US Census Bureau
        Table 6.
        (Accessed March 3, 2011)
        • Eversole G.M.
        • Moriarty A.T.
        • Schwartz M.R.
        • et al.
        Practices of participants in the college of American pathologists interlaboratory comparison program in cervicovaginal cytology, 2006.
        Arch Pathol Lab Med. 2010; 134: 331-335
        • Castle P.E.
        • Fetterman B.
        • Poitras N.
        • Lorey T.
        • Shaber R.
        • Kinney W.
        Five-year experience of human papillomavirus DNA and Papanicolaou test cotesting.
        Obstet Gynecol. 2009; 113: 595-600
        • Dunne E.F.
        • Unger E.R.
        • Sternberg M.
        • et al.
        Prevalence of HPV infection among females in the United States.
        JAMA. 2007; 297: 813-819
      3. American Society for Colposcopy and Cervical Pathology HPV genotyping clinical update 2009.
        (Accessed April 29, 2009)
        • Wright Jr, T.C.
        • Massad L.S.
        • Dunton C.J.
        • Spitzer M.
        • Wilkinson E.J.
        • Solomon D.
        2006 consensus guidelines for the management of women with abnormal cervical cancer screening tests.
        Am J Obstet Gynecol. 2007; 197: 346-355
        • Kulasingam S.L.
        • Hughes J.P.
        • Kiviat N.B.
        • et al.
        Evaluation of human papillomavirus testing in primary screening for cervical abnormalities: comparison of sensitivity, specificity, and frequency of referral.
        JAMA. 2002; 288: 1749-1757
        • Denny L.
        • Kuhn L.
        • De Souza M.
        • Pollack A.E.
        • Dupree W.
        • Wright Jr, T.C.
        Screen-and-treat approaches for cervical cancer prevention in low-resource settings: a randomized controlled trial.
        JAMA. 2005; 294: 2173-2181
        • Mayrand M.H.
        • Duarte-Franco E.
        • Rodrigues I.
        • et al.
        Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer.
        N Engl J Med. 2007; 357: 1579-1588
        • Sasieni P.
        Estimating prevalence when the true disease status is incompletely ascertained.
        Stat Med. 2001; 20: 935-949
        • Clifford G.M.
        • Rana R.K.
        • Franceschi S.
        • Smith J.S.
        • Gough G.
        • Pimenta J.M.
        Human papillomavirus genotype distribution in low-grade cervical lesions: comparison by geographic region and with cervical cancer.
        Cancer Epidemiol Biomarkers Prev. 2005; 14: 1157-1164
        • Smith J.S.
        • Lindsay L.
        • Hoots B.
        • et al.
        Human papillomavirus type distribution in invasive cervical cancer and high-grade cervical lesions: a meta-analysis update.
        Int J Cancer. 2007; 121: 621-632