Evaluating HPV negative CIN2+ in the ATHENA trial

Abstract

A post-hoc analysis of the ATHENA study was performed to determine whether true HPV negative cervical lesions occur and whether they have clinical relevance. The ATHENA database was searched for all CIN2 or worse (CIN2+) cases with cobas HPV negative results and comparison was made with Linear Array (LA) and Amplicor to detect true false-negative HPV results. Immunostaining with p16 was performed on these cases to identify false-positive histology results. H&E slides were re-reviewed by the study pathologists with knowledge of patient age, HPV test results and p16 immunostaining. Those with positive p16 immunostaining and/or a positive histopathology review underwent whole tissue section HPV PCR by the SPF10/LiPA/RHA system. Among 46,887 eligible women, 497 cases of CIN2+ were detected, 55 of which tested negative by the cobas® HPV Test (32 CIN2, 23 CIN3/ACIS). By LA and/or Amplicor, 32 CIN2+ (20 CIN2, 12 CIN3/ACIS) were HPV positive and categorized as false-negatives by cobas HPV; 9 of 12 false negative CIN3/ACIS cases were p16+. There were 23 cases (12 CIN2, 11 CIN3/ACIS) negative by all HPV tests; 7 of 11 CIN3/ACIS cases were p16+. H&E slides were available for 6 cases for re-review and all were confirmed as CIN3/ACIS. Tissue PCR was performed on the 6 confirmed CIN3/ACIS cases (and 1 without confirmation): 4 were positive for HPV types not considered oncogenic, 2 were positive for oncogenic genotypes and 1 was indeterminate. In summary, subanalysis of a large cervical cancer screening study did not identify any true CIN3/ACIS not attributable to HPV. This article is protected by copyright. All rights reserved.

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