OBJECTIVE:

To reclassify cervical biopsies with LIE-AG-NIC2 using hematoxylin eosin and p16, to estimate the association of misclassification with risk factor age, and to determine the diagnostic performance of p16 in defining the existence of LIE-AG.

MATERIALS AND METHODS:

Prospective, case series study carried out at the Faculty of Medicine of the University of Cartagena, Colombia. Cervical biopsies diagnosed during one year with LIE-AG-NIC2 were included. Cases with follow-up (cone or hysterectomy) were included and those without archived tissue were excluded. Expression of p16 was determined by immunohistochemistry. They were reclassified by two pathologists into two groups (≤LIE-BG/≤NIC1 and LIE-AG/≥NIC2) applying hematoxylin eosin and p16. 2 and Fisher’s test were applied for reclassification with p16 with respect to reclassification with hematoxylin eosin, taking p16 as reference. The proportion of reclassified samples and the OR of the relationship of these with the age groups (less than 30 years and more or less older than 30 years) were obtained.

RESULTS:

Thirty-nine cases were included. Of the follow-up studies, 10 of 39 were negative for LIE-AG/≥NIC2. Eighteen of the 39 cases evaluated with p16 reclassified to ≤LIE-BG/ ≤NIC1, of these 10 corresponded to those younger than 30 years. Fifteen of the 18 of the 18 of the cases reclassified as LIE-AG/≥NIC2 belonged to patients ≥ 30 years (OR = 0.368, 95%CI = 0.08-1.53). Interobserver agreement for determining outcome ≥ NIC2 with hematoxylin eosin was poor, and with p16 was moderate.

CONCLUSIONS:

Evaluation of cervical biopsies with the p16 marker along with hematoxylin eosin has greater diagnostic reproducibility than only using hematoxylin eosin, which increases interobserver agreement and reduces unnecessary treatment, especially in women younger than 30 years.

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