Long-term follow-up results of topical imiquimod for high-grade cervical intraepithelial neoplasia in young women: an original research

Abstract

<title>Abstract</title> Background As cervical excisional treatment is associated with adverse pregnancy outcomes, imiquimod has been explored in several studies—such as the TOPIC-3—as an alternative but without success. Therefore, we designed a study focusing on patients aged &lt; 35 years to verify its efficacy. Methods We conducted a retrospective, single-arm cohort study, gathering the medical records of nulliparous women aged &lt; 35 years who had never undergone cervical excisional therapy between October 2021 and March 2024. The primary goal was to identify the rate of histological regression and high-risk Human Papillomavirus (HPV) clearance at 3, 6, and 12 months, as well as beyond, after completing 8 weeks of weekly imiquimod treatment. Results The immediate regression rate from cervical intraepithelial neoplasia (CIN) 2 or 3 lesions to at least CIN 1 was 96.0% after 8 weeks of weekly imiquimod therapy, and the HPV clearance rate at that time was 47.3%. During follow-up, the observed rates of complete remission to normal, regression lower than that of CIN 1, and HPV clearance were 81.6%, 92.9%, and 56.0%, respectively. Notably, the subgroup of patients diagnosed with CIN 2 without HPV16 or 18 achieved the highest regression rate of 96.5%. Among the patients, 7.1% showed persistent disease, and only 1.0% underwent cervical invasive therapies. Conclusions We suggest that topical imiquimod therapies could serve as a potential alternative to postponing cervical excisional therapies for up to 1 year in women &lt; 35 years with CIN2 or 3, who are concerned about future pregnancy outcomes.