Abstract
Objective: To evaluate whether E7 mRNA can predict the risk of progression in women with HPV16 infection. Design: A prospective observational study. Setting: A tertiary university hospital. Population: A cohort of 139 women referred to colposcopy for an abnormal screening result fulfilling the following inclusion criteria: (1) a positive test result confirming HPV16 infection; (2) a biopsy sample with a histological diagnosis of an absence of lesion or low-grade SIL/CIN grade1 (LSIL/CIN1); (3) no previous HPV vaccination; (4) no pregnancy; and (5) no previous cervical treatments; and (6) no immunosuppression. Methods: At the first visit, all women underwent a cervical sample for liquid-based cytology, HPV testing and genotyping, and HPV16 E7 mRNA analysis and a colposcopy with at least one colposcopy-guided biopsy. Follow-up visits were scheduled every six months. In each control, a liquid-based Pap smear, HPV testing, as well as a colposcopy examination with biopsy if necessary were performed. Main outcome measures: Histological diagnosis of HSIL/CIN2+ at any time during follow-up. Results: E7 mRNA expression was positive in 55/127 (43.3%) women included in the study and seven (12.7%) progressed to HSIL/CIN2+. In contrast, only 1/72 (1.4%) women with no HPV16 E7 mRNA expression progressed (p = 0.027). HPV16 E7 mRNA expression was associated with a 10-fold increased risk of progression (HR 10.0; 95% CI 1.2–81.4). Conclusions: HPV16 E7 mRNA could be useful for risk stratification of women with HPV16 infection in whom a HSIL/CIN2+ has been ruled out. Funding: Instituto de Salud Carlos III (ICSIII)-Fondo de Investigación Sanitaria and ERDF ‘One Way to Europe’ (PI17/00772).
Highlights
According to the current guidelines [1,2], women with infection by human papillomavirus 16 (HPV16) warrant immediate colposcopy because of the high risk of harboring high-grade squamous intraepithelial lesion/cervical intraepithelial neoplasia grade 2 or worse (HSIL/CIN2+)
Five cases were excluded because of insufficient material or poor RNA quality for E7 mRNA assessment and seven women were lost to follow-up
Despite the limitations of this previous study, and the differences with the present series, the results reported in terms of prognostic value of E7 mRNA expression were similar to those of the present series
Summary
According to the current guidelines [1,2], women with infection by human papillomavirus 16 (HPV16) warrant immediate colposcopy because of the high risk of harboring high-grade squamous intraepithelial lesion/cervical intraepithelial neoplasia grade 2 or worse (HSIL/CIN2+). The risk of this subset of women developing HSIL/CIN2+ is still substantial over time compared with women testing negative [3,4]. This risk is variable from woman to woman [1,5,6,7]. It is clear that all women who are positive for HPV16 need to be closely followed, only a small percentage develop an HSIL/CIN2+ [8]. It is a priority to identify biomarkers in cervical cancer screening able to provide information on the risk of progression in these women with persistent HPV16 infection in whom
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