Abstract
Objective: 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.Methods: 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. Ninety seven patients in the control arm (CA) underwent no treatment (“watchful waiting”). Endpoints were cytological evolution, p16/Ki-67- and hr-HPV-clearances.Results: At 3 months, cytological regression was observed in 76% (57/75) of patients in the AA compared with 25% (24/97) in the CA. Progression occurred in 5% (4/75) of the AA compared with 15% (15/97) of the CA. The p16/Ki-67 status change was statistically significantly (p < 0.001) in favor of the AA: 77% (58/75) became negative compared to 21% (20/97) in the CA. hr-HPV prevalence decreased significantly (p < 0.001) in the AA from 87 to 44%, while increasing in the CA from 78 to 84%. Cytological regression and p16/Ki-67 changes persisted in the AA at 6 months.Conclusions: The vaginal gel significantly cleared hr-HPV and p16/Ki-67 and was associated with improved cytological findings, thereby potentially offering an effective option against oncogenic risk.Clinical Trial Registration: Identifier: [ISRCTN11009040].
Highlights
Cervical cancer remains a major cause of oncologic death in women in many developing countries
At 3 months, cytological regression was observed in 76% (57/75) of patients in the active arm (AA) compared with 25% (24/97) in the control arm (CA)
Progression occurred in 5% (4/75) of the AA compared with 15% (15/97) of the CA
Summary
Cervical cancer remains a major cause of oncologic death in women in many developing countries. It is rare in developed countries and mainly observed in postmenopausal women. By selecting lesions early on for oncogenic transformation with a biomarker, such as p16/Ki67, it is judicious to propose a preventive treatment during the watch and wait period before repeating the cervical smear or colposcopy. Watch and wait without therapeutic intervention is still part of all gynecological guidelines. This is unsatisfactory for both patients and gynecologists. While increasing the remission rate of the abnormal findings would lower mental stress, there is still no single validated, non-surgical therapeutic approach for mild-to-moderate cervical intraepithelial neoplasia (CIN)
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