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Gynecol Oncol. 2015 Feb;136(2):189-97. doi: 10.1016/j.ygyno.2014.11.076. Epub 2015 Jan 8.

Primary cervical cancer screening with human papillomavirus: end of study results from the ATHENA study using HPV as the first-line screening test.

Author information

1
Department of Pathology and Cell Biology, Columbia University, New York, NY, USA. Electronic address: tcw1@cumc.columbia.edu.
2
Department of Pathology, University of Virginia, Charlottesville, VA, USA. Electronic address: mhs2e@virginia.edu.
3
Roche Molecular Systems, Pleasanton, CA, USA. Electronic address: catherine_m.behrens@roche.com.
4
Roche Molecular Systems, Pleasanton, CA, USA. Electronic address: abha.sharma@roche.com.
5
Roche Molecular Systems, Pleasanton, CA, USA. Electronic address: guili.zhang@roche.com.
6
Genentech, South San Francisco, CA, USA. Electronic address: wright.teresa@gene.com.

Abstract

OBJECTIVES:

ATHENA evaluated the cobas HPV Test as the primary screen for cervical cancer in women ≥25years. This reports the 3-year end-of-study results comparing the performance of HPV primary screening to different screening and triage combinations.

METHODS:

42,209 women ≥25years were enrolled and had cytology and hrHPV testing. Women with abnormal cytology (≥atypical squamous cells of undetermined significance) and those HPV positive were referred to colposcopy. Women not reaching the study endpoint of CIN2+ entered the 3-year follow-up phase.

RESULTS:

3-year CIR of CIN3+ in cytology-negative women was 0.8% (95% CI; 0.5-1.1%), 0.3% (95% CI 0.1-0.7%) in HPV-negative women, and 0.3% (95% CI; 0.1-0.6%) in cytology and HPV negative women. The sensitivity for CIN3+ of cytology was 47.8% (95% CI; 41.6-54.1%) compared to 61.7% (95% CI; 56.0-67.5%) for the hybrid strategy (cytology if 25-29years and cotesting with cytology and HPV if ≥30years) and 76.1% (95% CI; 70.3-81.8%) for HPV primary. The specificity for CIN3+ was 97.1% (95% CI; 96.9-97.2%), 94.6% (95% CI; 94.4-94.8%), and 93.5% (95% CI; 93.3-93.8%) for cytology, hybrid strategy, and HPV primary, respectively. Although HPV primary detects significantly more cases of CIN3+ in women ≥25years than either cytology or hybrid strategy, it requires significantly more colposcopies. However, the number of colposcopies required to detect a single CIN3+ is the same as for the hybrid strategy.

CONCLUSIONS:

HPV primary screening in women ≥25years is as effective as a hybrid screening strategy that uses cytology if 25-29years and cotesting if ≥30years. However, HPV primary screening requires less screening tests.

KEYWORDS:

Cervical cancer screening; Cervical cytology; HPV

PMID:
25579108
DOI:
10.1016/j.ygyno.2014.11.076
[Indexed for MEDLINE]
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