Topical imiquimod treatment of residual or recurrent cervical intraepithelial neoplasia lesions (TOPIC‐2): A randomised controlled trial

To investigate the efficacy of imiquimod in women with residual or recurrent cervical intraepithelial neoplasia (rrCIN), compared with large loop excision of the transformation zone (LLETZ). Randomised controlled non-inferiority trial. One academic and one regional hospital in the Netherlands. Thirt...

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Published in:BJOG : an international journal of obstetrics and gynaecology Vol. 132; no. 8; pp. 1056 - 1064
Main Authors: van de Sande, Anna J. M., van Baars, Romy, Koeneman, Margot M., Gerestein, Cornelis G., Kruse, Arnold‐Jan, van Esch, Edith M. G., de Vos van Steenwijk, Peggy J., Muntinga, Caroline L. P., Willemsen, Sten P., van Doorn, Helena C., van Kemenade, Folkert J., van Beekhuizen, Helene J.
Format: Journal Article
Language:English
Published: England Wiley Subscription Services, Inc 01.07.2025
John Wiley and Sons Inc
Subjects:
Administration, Intravaginal
Adult
Antineoplastic Agents - administration & dosage
Cellular biology
Cytology
Female
Human papillomavirus
Humans
Hysterectomy
Imiquimod
Imiquimod - administration & dosage
Imiquimod - adverse effects
Lesions
Middle Aged
Neoplasm Recurrence, Local - drug therapy
Neoplasm Recurrence, Local - pathology
Neoplasm, Residual - drug therapy
Netherlands
Papillomavirus Infections
Patients
Randomised Controlled Trial
Side effects
Treatment Outcome
Uterine Cervical Dysplasia - drug therapy
Uterine Cervical Dysplasia - pathology
Uterine Cervical Dysplasia - surgery
Uterine Cervical Dysplasia - virology
Uterine Cervical Neoplasms - drug therapy
Uterine Cervical Neoplasms - pathology
Uterine Cervical Neoplasms - surgery
Uterine Cervical Neoplasms - virology
Netherlands
high‐grade squamous intraepithelial lesion
large loop excision of the transformation zone
transformation zone
prevention of cervical cancer
human papillomavirus
imiquimod
cervical dysplasia
quality of life
cervical intraepithelial neoplasia
efficacy
ISSN:1470-0328, 1471-0528, 1471-0528
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Summary:To investigate the efficacy of imiquimod in women with residual or recurrent cervical intraepithelial neoplasia (rrCIN), compared with large loop excision of the transformation zone (LLETZ). Randomised controlled non-inferiority trial. One academic and one regional hospital in the Netherlands. Thirty-five women with rrCIN were included in the study between May 2016 and May 2021. Women were randomised to receive treatment with 5% imiquimod cream (12.5 mg) intravaginally (three times a week for a duration of 16 weeks) or a LLETZ procedure (standard treatment). The primary outcome was reduction to normal cytology at 6 months after starting treatment. Secondary outcomes were clearance of high-risk human papilloma virus (hr-HPV) in both groups and reduction to ≤CIN1 in the imiquimod group. Side effects were monitored. Treatment success was 33% (6/18) in the imiquimod group versus 100% (16/16) in the LLETZ group (P < 0.001), whereas HPV clearance was 22% (4/18) in the imiquimod group versus 88% (14/16) in the LLETZ group (P < 0.001). After the randomisation of 35 women, the futility of treatment with imiquimod was proven and the trial was prematurely finished. In the follow-up period, three patients remained without additional treatment, whereas all other patients underwent LLETZ, conisation or hysterectomy. In the LLETZ group none of the patients received additional treatment during 2 years of follow-up. This is the first randomised controlled trial to show that topical imiquimod has a significantly lower success rate in terms of reduction to normal cytology and hr-HPV clearance, compared with LLETZ, in women with rrCIN. Additionally, imiquimod has numerous side effects and after using imiquimod most women with rrCIN still required additional surgical treatment.
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Trial registration: Medical Ethical Committee approval number: NL 53792.078.15/MEC‐2015‐389. Affiliation: Erasmus MC. ClinicalTrials.gov: NCT02669459, 27 January 2016.
ISSN:1470-0328
1471-0528
1471-0528
DOI:10.1111/1471-0528.17808