Comparison of Conservative Treatment of Cervical Intraepithelial Lesions with Imiquimod with Standard Excisional Technique Using LLETZ: A Randomized Controlled Trial

Abstract

(1) Background: There are limited data on the success of conservative treatment of high-grade cervical squamous intraepithelial lesions (HSIL) with imiquimod directly compared to standard of treatment with LLETZ. (2) Methods: Patients aged 18–40 with histological HSIL (with high-grade cervical intraepithelial neoplasia, CIN2p16+ and CIN3), were randomly assigned to treatment with imiquimod or LLETZ. The primary outcome was defined as the absence of HSIL after either treatment modality. The secondary outcomes were the occurrence of side effects. (3) Results: 52 patients were allocated in each group and were similar regarding baseline characteristics. In the imiquimod group, 82.7% of patients completed treatment, which was successful in 51.9%. All patients in the LLETZ group completed treatment, which was successful in 92.3% (p < 0.001). In the subgroup of CIN2p16+ patients, treatment with imiquimod was not inferior to LLETZ (73.9% vs. 84.2%, p = 0.477). During and after treatment, no cases of progression to cancer were observed. Side effects and severe side effects (local and systemic) were more prevalent in the imiquimod than in the LLETZ group (88.5% vs. 44.2% (p-value < 0.001) and 51.9% vs. 13.5% (p-value < 0.001), respectively). (4) Conclusion: Generally, in patients with HSIL, LLETZ remains the gold standard of treatment. However, in a subgroup analysis of patients with CIN2p16+, the success rate was comparable between the two treatment modalities. Due to the prevalence of side effects, the treatment compliance with imiquimod use may, however, present a clinically important issue.

Importance of the Immune Microenvironment in the Spontaneous Regression of Cervical Squamous Intraepithelial Lesions (cSIL) and Implications for Immunotherapy

“…The side effects, however, upon imiquimod application, are common, and can be extensive, including systemic adverse events, but they mostly consist of local inflammation and burning [ 25 ]. Consequently, therapy adherence is challenging, with up to 20% discontinuation of treatment due to the side effects and treatment duration of 16 weeks [ 26 , 27 ]. Therefore prediction of spontaneous regression and imiquimod effectivity in cHSIL would be of aid in patient selection and counseling.…”

A case report and literature review of delayed telogen effluvium after topical imiquimod use in treating a cervical high-grade squamous intraepithelial lesion

“…Substantial hair loss is principally noticeable in the third picture (approximately one month after the treatment). use) is relatively successful, it is still inferior to standard treatment with LLETZ and might be associated with various side effects ranging from mild to severe [3][4][5][6][7][8].…”

“…A 24-year-old nulliparous patient, otherwise healthy, without a history of prescribed medications, allergies and abnormal uterine bleeding, no current use of contraceptives and a nonsmoker, was diagnosed with a high-grade squamous intraepithelial lesion (HSIL) (cervical intraepithelial neoplasia-CIN 3). The patient had visited different treatment modalities for treatment suggestions, and because she was reluctant to undergo surgery, she accepted to participate in our ongoing study [3]. She started treatment at the beginning of May 2020, whereby imiquimod was used intravaginally using an applicator three times per week for 16 weeks (cumulative dose of 600 mg) based on the study protocol.…”

Inosine pranobex in the treatment of mild cervical intraepithelial neoplasia (experience of clinical use)

“…Рак шейки матки является одним из наиболее распро страненных злокачественных новообразований женской репродуктивной системы [1 -3 ]. Последние статистиче ские данные показали, что у 500 000 женщин в год диа гностируют цервикальную карциному [4,5]. В РФ распро страненность РШМ составляет 126,8 на 100 тыс.…”

“…На сегодняшний день не существует специфических противовирусных препаратов, способных полностью эли минировать вирус папилломы человека из организма хозяина [5,13,19]. При этом, когда имеются нарушения защитных систем в организме хозяина и они не способ ны к адекватному ответу на вирусное воздействие, может быть необходима его модуляция [16,20].…”