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Controlled Clinical Trial
. 2022 Apr 1;45(3):180-186.
doi: 10.1097/CJI.0000000000000414.

Topical Imiquimod Treatment of High-grade Cervical Intraepithelial Neoplasia (TOPIC-3): A Nonrandomized Multicenter Study

Natasja Hendriks  1   2 , Margot M Koeneman  1   2 , Anna J M van de Sande  3 , Charlotte G J Penders  1   2 , Jurgen M J Piek  4 , Loes F S Kooreman  5   2 , Sander M J van Kuijk  6   7 , Linde Hoosemans  1 , Simone J S Sep  8   7 , Peggy J de Vos Van Steenwijk  1   2 , Heleen J van Beekhuizen  3 , Brigitte F M Slangen  1   2 , Hans W Nijman  9 , Roy F P M Kruitwagen  1   2 , Arnold-Jan Kruse  1   2   10
Affiliations
Controlled Clinical Trial

Topical Imiquimod Treatment of High-grade Cervical Intraepithelial Neoplasia (TOPIC-3): A Nonrandomized Multicenter Study

Natasja Hendriks et al. J Immunother. .

Abstract

Topical imiquimod could be an alternative, noninvasive, treatment modality for high-grade cervical intraepithelial neoplasia (CIN). However, evidence is limited, and there are no studies that compared treatment effectiveness and side effects of topical imiquimod cream to standard large loop excision of the transformation zone (LLETZ) treatment. A multi-center, nonrandomized controlled trial was performed among women with a histologic diagnosis of CIN 2/3. Women were treated with either vaginal imiquimod (6.25 mg 3 times weekly for 8 to 16 wk) or LLETZ according to their own preference. Successful treatment was defined as the absence of high-grade dysplasia at the first follow-up interval after treatment (at 20 wk for the imiquimod group and at 26 wk for the LLETZ group). Secondary outcome measures were high-risk human papillomavirus (hrHPV) clearance, side effects, and predictive factors for successful imiquimod treatment. Imiquimod treatment was successful in 60% of women who completed imiquimod treatment and 95% of women treated with LLETZ. hrHPV clearance occurred in 69% and 67% in the imiquimod group and LLETZ group, respectively. This study provides further evidence on topical imiquimod cream as a feasible and safe treatment modality for high-grade CIN. Although the effectiveness is considerably lower than LLETZ treatment, imiquimod treatment could prevent initial surgical treatment in over 40% of women and should be offered to a selected population of women who wish to avoid (repeated) surgical treatment of high-grade CIN.

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Conflict of interest statement

This study was partially funded by a research grant from MEDA Pharmaceuticals. This grant was used to cover costs for the study medication and laboratory analyses. MEDA Pharmaceuticals was not involved in study design, data collection, data analysis and interpretation or the content of the current publication.

All authors have declared that there are no financial conflicts of interest with regard to this work.

Figures

FIGURE 1
FIGURE 1
Study CONSORT diagram. CIN indicates cervical intraepithelial neoplasia; LLETZ, large loop excision of the transformation zone.
See this image and copyright information in PMC

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