PURPOSE: Our aim was to detect and evaluate potential alterations in the postoperative status of E6/E7 HPV mRNA in women treated for cervical intraepithelial lesions (CIN) and if so, to evaluate its potential use as a prognostic tool to identify patients with increased risk of treatment failure or recurrent disease.
METHODS: Our study retrospectively analyzed 101 women with an abnormal Pap smear, or in some cases with histological reports or molecular analysis requiring colposcopic evaluation. Thin-prep cytological samples were collected before colposcopy and histology (when necessary). After treatment, all women were scheduled for colposcopy in six months. The cytological material was analyzed with CLART-2 HPV-DNA test and HPV-PROOFER E6/E7 mRNA test.
RESULTS: Concerning demographics, no significant correlations were found for smoking, condom use or vaccination status. It seems that the only statistically significant correlation with actual severity came from the mRNA-test after treatment. This shows that clinical cases with more severe CIN may have higher chances of unsuccessful treatment. At the first post-op visit, 83.5% of HPV mRNA-positive women had a negative HPV mRNA-test while only 60.4% of HPV DNA-positive women became negative. There were 12 HPV-mRNA positive patients both before and after treatment, 3 of whom had a negative HPV DNA test, meaning that, if based only on HPV-DNA results, they would have been managed wrongly as successfully treated patients. Our study shows that E6/E7 mRNA detection has particularly high specificity and positive likelihood ratio for the prediction of treatment failure in comparison with HPV DNA-testing.
CONCLUSIONS: E6/E7 mRNA overexpression seems to be a promising candidate as an indicator-biomarker to determine the success of treatment.