Author(s): Wright TC, Stoler MH, Behrens CM, Sharma A, Zhang G,
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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. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.
This article was published in Gynecol Oncol
and referenced in Diagnostic Pathology: Open Access