Objective: The p16 (p16(Ink4a)) tumor-suppressor protein is a biomarker for activated expression of human papillomavirus oncogenes. However, data are insufficient to determine whether p16 overexpression predicts the risk for progression of low-grade cervical intraepithelial neoplasia (CIN). This study was aimed at evaluating the risk for progression to CIN2 or worse during a 3-year follow-up of an unselected series of 739 patients with CIN1 biopsy specimens tested for p16 expression.
Methods: Positivity of p16 was defined as a diffuse overexpression in the basal/parabasal cell layers. Selection biases were ruled out using a control group of 523 patients with CIN1 biopsies not tested for p16 expression. Analysis was based on the ratio of progression rates.
Results: In the first year of follow-up, the 216 patients (29%) with p16-positive CIN1 had a higher progression rate (12.3%) than did the 523 patients with p16-negative CIN1 (2.2%) (rate ratio, 5.5; 95% confidence interval [CI], 2.59-11.71). In the second and third years, differences were smaller (rate ratio, 1.32 and 1.14, respectively) and not significant. The patients with p16-positive CIN1 also had a lower risk for regression to normal in the first year of follow-up (rate ratio, 0.55; 95% confidence interval, 0.42-0.71) and nonsignificant changes in the second and third years (rate ratio, 0.81 and 0.84, respectively).
Conclusions: The patients with p16-positive CIN1 had an increased risk for progression that was concentrated in the first year of follow-up. Immunostaining of p16 could have a role in short-term surveillance of patients with CIN1. Further research should focus on midterm/long-term outcomes of p16-positive CIN1.
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http://dx.doi.org/10.1097/IGC.0b013e3182a80b14 | DOI Listing |
Objective: This study aimed to investigate the preventive effect of a vaginal gel on p16/Ki-67-positive abnormal cytological cervical findings (ASC-US, LSIL) and hr-HPV in women.
Methods: The study included 134 women with p16/Ki-67-positive ASC-US or LSIL. Participants were selected from a randomized controlled trial that focused on women with histological diagnoses of p16-positive CIN1 lesions or CIN2.
J Cancer Res Clin Oncol
August 2022
Department of Pathology, Dunedin School of Medicine, University of Otago, P O Box 56, Dunedin, New Zealand.
Background: Progression of cervical intraepithelial neoplasia (CIN) to higher grade disease is associated with persistent human papillomavirus (HPV) infection and an absence of immune-mediated regression. However, the immune microenvironment that distinguishes progression from persistent or regressing lesions has not been well defined.
Methods: A total of 69 patients under the age of 25 with high-risk HPV-positive cytology and biopsy-confirmed p16-positive CIN2 were included in the study.
Front Med (Lausanne)
May 2021
Department of Obstetrics and Gynaecology, University Hospital of Geneva, Geneva, Switzerland.
To analyze the course of p16/Ki-67-positive abnormal cytological cervical findings and high risk (hr)-HPV- and p16/Ki-67-clearances in women treated with a vaginal gel. 172 women with a histological diagnosis of CIN2 or p16-positive CIN1 lesions were selected based on a positive cytological p16/Ki-67 test. For 3 months, 75 patients in the active arm (AA) daily administered 5 ml of a vaginal gel.
View Article and Find Full Text PDFArch Gynecol Obstet
February 2021
Phidalsa Pharma-Consultants, Petit-Lancy/Geneva, Switzerland.
Purpose: The effect of SAM vaginal gel, a medical device containing adsorptive silicon dioxide and antioxidative sodium selenite and citric acid, on histologically-proven cervical intraepithelial neoplasia type 2 (CIN2) as well as p16 positive CIN1, and on the presence of the onco-marker p16 was investigated.
Methods: 216 women aged 25-60 years were randomized to either receive an intravaginal daily dose of SAM gel for three 28-day periods, or be followed-up without intervention. The primary endpoint was efficacy, defined as a combined histological and cytological regression.
Oncol Lett
August 2020
Department of Pathology, Peking University People's Hospital, Beijing 100044, P.R. China.
According to the 2014 World Health Organization Classification of Tumors of Female Reproductive Organs, patients with cervical intraepithelial neoplasia 2 (CIN2) have an equivocal diagnosis, but p16 is considered as the reference index for CIN2. Positive p16 expression in CIN2 is associated with high-grade squamous intraepithelial lesions (HSIL), whereas p16 negative lesions are low-grade squamous intraepithelial lesions. The purpose of the present study was to examine the clinical value of p16 and human papillomavirus (HPV) E6/E7 mRNA in the prognostication of patients with CIN2.
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