FIGO / IGCS statement on the efficacy of topical treatments for high‐risk human papillomavirus in preventing CIN 3+ lesions

Cervical cancer is caused by persistent high-risk human papillomavirus (HR-HPV) infection and remains a major global health burden despite available preventive strategies. Most HR-HPV infections and associated low-grade squamous intraepithelial lesions (LSIL) regress spontaneously, yet increasing commercial promotion of topical therapies targeting HPV clearance has emerged in clinical practice. This FIGO/International Gynecologic Cancer Society (IGCS) Position Statement critically appraises the available evidence on topical treatments for HR-HPV infection and LSIL, and provides evidence-based recommendations for clinical practice and future research. No randomized controlled trial has been adequately designed or powered to evaluate the effect of topical therapies on the prevention of histologically confirmed high-grade squamous intraepithelial lesions (HSIL/CIN3+). Available studies are characterized by small sample sizes, short follow-up periods, heterogeneous populations, inadequate comparators, and reliance on surrogate endpoints of uncertain clinical relevance, including cytological regression, HPV nondetection, and immunohistochemical markers such as p16/Ki-67. Published meta-analyses reporting statistically significant improvements in virological and cytological surrogates are limited by substantial heterogeneity, publication bias, and follow-up periods under 1 year. Product-specific appraisal of Coriolus versicolor-based and silicon dioxide/selenite-based vaginal gels reveal additional methodological concerns, including retrospective trial registration, industry funding, and misinterpretation of findings consistent with the spin phenomenon. In the absence of high-quality evidence demonstrating clinically meaningful benefit, FIGO and IGCS do not endorse the routine clinical use of any currently available topical agent for HR-HPV infection or LSIL. Evidence-based surveillance remains the standard of care. Future research should prioritize rigorous trial design with histologically confirmed HSIL/CIN3+ as the primary endpoint, adequate follow-up of at least 3 years, and appropriate comparators. Clinical management should center on informed shared decision-making and evidence-based counseling, rather than on interventions lacking proven clinical benefit.

Authors

Institutions

Publication Details

Journal
International Journal of Gynecology & Obstetrics
Published
2026-09-01
DOI
https://doi.org/10.1002/ijgo.71285
Primary Topic
Cervical Cancer and HPV Research
Type
article
Field-Weighted Citation Impact
0.00
Controls
|||
ALL TIME
JAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
article

FIGO / IGCS statement on the efficacy of topical treatments for high‐risk human papillomavirus in preventing CIN 3+ lesions

Gabriel Levin, Nadeem R. Abu‐Rustum, Aureli Torné, Sílvia de Sanjosé et al.
International Journal of Gynecology & Obstetrics
Cervical Cancer and HPV Research
article

FIGO / IGCS statement on the efficacy of topical treatments for high‐risk human papillomavirus in preventing CIN 3+ lesions

Gabriel Levin, Nadeem R. Abu‐Rustum, Aureli Torné, Sílvia de Sanjosé, Christina Fotopoulou, Neerja Bhatla, Angélica V Fletcher, Munachiso Iheme Ndukwe, Patrick Petignat, Marta del Pino, Lina María Trujillo, Lisa Flowers, José Jerónimo, Mauricio A. Cuello, Suzanne M. Garland, Gloria Inés Sánchez, Emmanuel Sánchez Díaz, Barbara Schmalfeldt, Maria Kyrgiou, Sarikapan Wilailak, René Pareja, Fernando Martínez Heredia
article en

Abstract

Cervical cancer is caused by persistent high-risk human papillomavirus (HR-HPV) infection and remains a major global health burden despite available preventive strategies. Most HR-HPV infections and associated low-grade squamous intraepithelial lesions (LSIL) regress spontaneously, yet increasing commercial promotion of topical therapies targeting HPV clearance has emerged in clinical practice. This FIGO/International Gynecologic Cancer Society (IGCS) Position Statement critically appraises the available evidence on topical treatments for HR-HPV infection and LSIL, and provides evidence-based recommendations for clinical practice and future research. No randomized controlled trial has been adequately designed or powered to evaluate the effect of topical therapies on the prevention of histologically confirmed high-grade squamous intraepithelial lesions (HSIL/CIN3+). Available studies are characterized by small sample sizes, short follow-up periods, heterogeneous populations, inadequate comparators, and reliance on surrogate endpoints of uncertain clinical relevance, including cytological regression, HPV nondetection, and immunohistochemical markers such as p16/Ki-67. Published meta-analyses reporting statistically significant improvements in virological and cytological surrogates are limited by substantial heterogeneity, publication bias, and follow-up periods under 1 year. Product-specific appraisal of Coriolus versicolor-based and silicon dioxide/selenite-based vaginal gels reveal additional methodological concerns, including retrospective trial registration, industry funding, and misinterpretation of findings consistent with the spin phenomenon. In the absence of high-quality evidence demonstrating clinically meaningful benefit, FIGO and IGCS do not endorse the routine clinical use of any currently available topical agent for HR-HPV infection or LSIL. Evidence-based surveillance remains the standard of care. Future research should prioritize rigorous trial design with histologically confirmed HSIL/CIN3+ as the primary endpoint, adequate follow-up of at least 3 years, and appropriate comparators. Clinical management should center on informed shared decision-making and evidence-based counseling, rather than on interventions lacking proven clinical benefit.

International Journal of Gynecology & Obstetrics
Royal Women's Hospital (AU), Memorial Sloan Kettering Cancer Center (US), Emory University (US), Imperial College Healthcare NHS Trust (GB), Pontificia Universidad Católica de Chile (CL), University of Concepción (CL), Cornell University (US), Mahidol University (TH), Eppendorf (Germany) (DE), McGill University Health Centre (CA), Universidad de Antioquia (CO), Klinik und Poliklinik für Urologie (DE), University Hospital of Geneva (CH), Clínica Somer (CO), Hospital Clínic de Barcelona (ES), Instituto Nacional de Cancerología (CO), Hospital Regional de Concepción (CL), University Hospital Hradec Králové (CZ), Ramathibodi Hospital (TH), National Cancer Institute (US), Universidad de Ibagué (CO), Klinik und Poliklinik für Neurologie (DE), Barcelona Institute for Global Health (ES), Murdoch Children's Research Institute (AU), Melbourne Health (AU), Consorci Institut D'Investigacions Biomediques August Pi I Sunyer (ES), Division of Cancer Epidemiology and Genetics, Imperial College London (GB), All India Institute of Medical Sciences (IN), Universitat de Barcelona (ES), University of Hradec Králové (CZ)
Partnerships for the goals
Openalex Percentile: Top 10%
Cervical Cancer and HPV Research
DOISourceOpenAlex
AI Navigator

Ask Laika to Summarize, Analyze, and Connect papers live on the map.

Summarize Papers & Methodologies

Extract key findings, datasets, and comparative methods across publications.

Benchmark Rankings & Visual Analytics

Rank top research institutions, authors, funders, topics, and journals by Field-Weighted Citation Impact (FWCI) and paper volume with instant charts.

Connect Distant Disciplines

Bridge topological clusters on the map to find hidden collaborative intersections.