Cargando…

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

(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 intra...

Descripción completa

Detalles Bibliográficos
Autores principales: Cokan, Andrej, Pakiž, Maja, Serdinšek, Tamara, Dovnik, Andraž, Kodrič, Tatjana, Repše Fokter, Alenka, Kavalar, Rajko, But, Igor
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8706260/
https://www.ncbi.nlm.nih.gov/pubmed/34945073
http://dx.doi.org/10.3390/jcm10245777
_version_ 1784622149623873536
author Cokan, Andrej
Pakiž, Maja
Serdinšek, Tamara
Dovnik, Andraž
Kodrič, Tatjana
Repše Fokter, Alenka
Kavalar, Rajko
But, Igor
author_facet Cokan, Andrej
Pakiž, Maja
Serdinšek, Tamara
Dovnik, Andraž
Kodrič, Tatjana
Repše Fokter, Alenka
Kavalar, Rajko
But, Igor
author_sort Cokan, Andrej
collection PubMed
description (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.
format Online
Article
Text
id pubmed-8706260
institution National Center for Biotechnology Information
language English
publishDate 2021
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-87062602021-12-25 Comparison of Conservative Treatment of Cervical Intraepithelial Lesions with Imiquimod with Standard Excisional Technique Using LLETZ: A Randomized Controlled Trial Cokan, Andrej Pakiž, Maja Serdinšek, Tamara Dovnik, Andraž Kodrič, Tatjana Repše Fokter, Alenka Kavalar, Rajko But, Igor J Clin Med Article (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. MDPI 2021-12-10 /pmc/articles/PMC8706260/ /pubmed/34945073 http://dx.doi.org/10.3390/jcm10245777 Text en © 2021 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Cokan, Andrej
Pakiž, Maja
Serdinšek, Tamara
Dovnik, Andraž
Kodrič, Tatjana
Repše Fokter, Alenka
Kavalar, Rajko
But, Igor
Comparison of Conservative Treatment of Cervical Intraepithelial Lesions with Imiquimod with Standard Excisional Technique Using LLETZ: A Randomized Controlled Trial
title Comparison of Conservative Treatment of Cervical Intraepithelial Lesions with Imiquimod with Standard Excisional Technique Using LLETZ: A Randomized Controlled Trial
title_full Comparison of Conservative Treatment of Cervical Intraepithelial Lesions with Imiquimod with Standard Excisional Technique Using LLETZ: A Randomized Controlled Trial
title_fullStr Comparison of Conservative Treatment of Cervical Intraepithelial Lesions with Imiquimod with Standard Excisional Technique Using LLETZ: A Randomized Controlled Trial
title_full_unstemmed Comparison of Conservative Treatment of Cervical Intraepithelial Lesions with Imiquimod with Standard Excisional Technique Using LLETZ: A Randomized Controlled Trial
title_short Comparison of Conservative Treatment of Cervical Intraepithelial Lesions with Imiquimod with Standard Excisional Technique Using LLETZ: A Randomized Controlled Trial
title_sort comparison of conservative treatment of cervical intraepithelial lesions with imiquimod with standard excisional technique using lletz: a randomized controlled trial
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8706260/
https://www.ncbi.nlm.nih.gov/pubmed/34945073
http://dx.doi.org/10.3390/jcm10245777
work_keys_str_mv AT cokanandrej comparisonofconservativetreatmentofcervicalintraepitheliallesionswithimiquimodwithstandardexcisionaltechniqueusinglletzarandomizedcontrolledtrial
AT pakizmaja comparisonofconservativetreatmentofcervicalintraepitheliallesionswithimiquimodwithstandardexcisionaltechniqueusinglletzarandomizedcontrolledtrial
AT serdinsektamara comparisonofconservativetreatmentofcervicalintraepitheliallesionswithimiquimodwithstandardexcisionaltechniqueusinglletzarandomizedcontrolledtrial
AT dovnikandraz comparisonofconservativetreatmentofcervicalintraepitheliallesionswithimiquimodwithstandardexcisionaltechniqueusinglletzarandomizedcontrolledtrial
AT kodrictatjana comparisonofconservativetreatmentofcervicalintraepitheliallesionswithimiquimodwithstandardexcisionaltechniqueusinglletzarandomizedcontrolledtrial
AT repsefokteralenka comparisonofconservativetreatmentofcervicalintraepitheliallesionswithimiquimodwithstandardexcisionaltechniqueusinglletzarandomizedcontrolledtrial
AT kavalarrajko comparisonofconservativetreatmentofcervicalintraepitheliallesionswithimiquimodwithstandardexcisionaltechniqueusinglletzarandomizedcontrolledtrial
AT butigor comparisonofconservativetreatmentofcervicalintraepitheliallesionswithimiquimodwithstandardexcisionaltechniqueusinglletzarandomizedcontrolledtrial