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Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial -- the HPV FOCAL Study.

Abstract

BACKGROUND

Round 1 data of human papillomavirus (HPV) FOCAL, a three-arm, randomised trial, which aims to establish the efficacy of HPV DNA testing as a primary screen for cervical cancer, are presented.

METHODS

The three arms are: Control arm - liquid based cytology with atypical squamous cells of unknown significance (ASC-US) triage with hrHPV testing; Intervention Arm - hrHPV at entry with liquid-based cytology (LBC) triage of hrHPV positives, with exit screen at 4 years; Safety check arm - hrHPV at entry with LBC triage of hrHPV positives with exit screen at 2 years.

RESULTS

A total of 6154 women were randomised to the control arm and 12 494 to the HPV arms (intervention and safety check). In the HPV arm, the baseline cervical intraepithelial neoplasia (CIN)2+ and CIN3+ rate was 9.2/1000 (95%CI; 7.4, 10.9) and 4.8/1000 (95%CI; 3.6, 6.1), which increased to 16.1/1000 (95%CI 13.2, 18.9) for CIN2+ and to 8.0/1000 (95%CI; 5.9, 10.0) for CIN3+ after subsequent screening of HPV-DNA-positive/cytology-negative women. Detection rate in the control arm remained unchanged after subsequent screening of ASC-US-positive/hrHPV DNA-negative women at 11.0/1000 for CIN2+ and 5.0/1000 for CIN3+.

CONCLUSION

After subsequent screening of women who were either hrHPV positive/cytology negative or ASC-US positive/HPV negative, women randomised to the HPV arms had increased CIN2+ detection compared with women randomised to the cytology arm.

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  • Authors+Show Affiliations

    ,

    Department of Family Practice, University of British Columbia, Vancouver V5Z 4R4, British Columbia, Canada. gina.ogilvie@bccdc.ca

    , , , , , , , , , , ,

    Source

    British journal of cancer 107:12 2012 Dec 04 pg 1917-24

    MeSH

    Adult
    Algorithms
    Alphapapillomavirus
    Canada
    Carcinoma, Squamous Cell
    Cervical Intraepithelial Neoplasia
    Colposcopy
    Cytological Techniques
    DNA, Viral
    Early Detection of Cancer
    Female
    Humans
    Mass Screening
    Middle Aged
    Papillomavirus Infections
    Sexual Partners
    Uterine Cervical Neoplasms
    Vaginal Smears

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial

    Language

    eng

    PubMed ID

    23169286

    Citation

    Ogilvie, G S., et al. "Primary Cervical Cancer Screening With HPV Testing Compared With Liquid-based Cytology: Results of Round 1 of a Randomised Controlled Trial -- the HPV FOCAL Study." British Journal of Cancer, vol. 107, no. 12, 2012, pp. 1917-24.
    Ogilvie GS, Krajden M, van Niekerk DJ, et al. Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial -- the HPV FOCAL Study. Br J Cancer. 2012;107(12):1917-24.
    Ogilvie, G. S., Krajden, M., van Niekerk, D. J., Martin, R. E., Ehlen, T. G., Ceballos, K., ... Coldman, A. J. (2012). Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial -- the HPV FOCAL Study. British Journal of Cancer, 107(12), pp. 1917-24. doi:10.1038/bjc.2012.489.
    Ogilvie GS, et al. Primary Cervical Cancer Screening With HPV Testing Compared With Liquid-based Cytology: Results of Round 1 of a Randomised Controlled Trial -- the HPV FOCAL Study. Br J Cancer. 2012 Dec 4;107(12):1917-24. PubMed PMID: 23169286.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial -- the HPV FOCAL Study. AU - Ogilvie,G S, AU - Krajden,M, AU - van Niekerk,D J, AU - Martin,R E, AU - Ehlen,T G, AU - Ceballos,K, AU - Smith,L W, AU - Kan,L, AU - Cook,D A, AU - Peacock,S, AU - Stuart,G C E, AU - Franco,E L, AU - Coldman,A J, Y1 - 2012/11/20/ PY - 2012/11/22/entrez PY - 2012/11/22/pubmed PY - 2013/2/16/medline SP - 1917 EP - 24 JF - British journal of cancer JO - Br. J. Cancer VL - 107 IS - 12 N2 - BACKGROUND: Round 1 data of human papillomavirus (HPV) FOCAL, a three-arm, randomised trial, which aims to establish the efficacy of HPV DNA testing as a primary screen for cervical cancer, are presented. METHODS: The three arms are: Control arm - liquid based cytology with atypical squamous cells of unknown significance (ASC-US) triage with hrHPV testing; Intervention Arm - hrHPV at entry with liquid-based cytology (LBC) triage of hrHPV positives, with exit screen at 4 years; Safety check arm - hrHPV at entry with LBC triage of hrHPV positives with exit screen at 2 years. RESULTS: A total of 6154 women were randomised to the control arm and 12 494 to the HPV arms (intervention and safety check). In the HPV arm, the baseline cervical intraepithelial neoplasia (CIN)2+ and CIN3+ rate was 9.2/1000 (95%CI; 7.4, 10.9) and 4.8/1000 (95%CI; 3.6, 6.1), which increased to 16.1/1000 (95%CI 13.2, 18.9) for CIN2+ and to 8.0/1000 (95%CI; 5.9, 10.0) for CIN3+ after subsequent screening of HPV-DNA-positive/cytology-negative women. Detection rate in the control arm remained unchanged after subsequent screening of ASC-US-positive/hrHPV DNA-negative women at 11.0/1000 for CIN2+ and 5.0/1000 for CIN3+. CONCLUSION: After subsequent screening of women who were either hrHPV positive/cytology negative or ASC-US positive/HPV negative, women randomised to the HPV arms had increased CIN2+ detection compared with women randomised to the cytology arm. SN - 1532-1827 UR - https://www.unboundmedicine.com/medline/citation/23169286/Primary_cervical_cancer_screening_with_HPV_testing_compared_with_liquid_based_cytology:_results_of_round_1_of_a_randomised_controlled_trial____the_HPV_FOCAL_Study_ L2 - http://dx.doi.org/10.1038/bjc.2012.489 DB - PRIME DP - Unbound Medicine ER -