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Efficacy of Thermal Ablation for Treatment of High-Grade Cervical Dysplasia Among HIV-Positive Women: Preliminary Results From Western Kenya
In 2019, the World Health Organization (WHO) endorsed thermal ablation (TA) for use within “screen-and-treat” cervical cancer prevention programs in low- and middle-income countries (LMICs), including among women living with HIV (WLWH). We evaluated TA efficacy for treatment of biopsy-confirmed cerv...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Wolters Kluwer Health
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9906534/ http://dx.doi.org/10.1200/GO.22.40000 |
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author | Mungo, Chemtai Ogollah, Cyrillus Ambaka, Jennifer Omoto, Jackton Cohen, Craig |
author_facet | Mungo, Chemtai Ogollah, Cyrillus Ambaka, Jennifer Omoto, Jackton Cohen, Craig |
author_sort | Mungo, Chemtai |
collection | PubMed |
description | In 2019, the World Health Organization (WHO) endorsed thermal ablation (TA) for use within “screen-and-treat” cervical cancer prevention programs in low- and middle-income countries (LMICs), including among women living with HIV (WLWH). We evaluated TA efficacy for treatment of biopsy-confirmed cervical intraepithelial neoplasia grades 2 and 3 (CIN2/3) among WLWH in western Kenya (ClinicalTrials.gov NCT04191967). METHODS: Between August 2019 and November 2020, WLWH age 25-65 years underwent high-risk human papillomavirus (hrHPV) self-collection. hrHPV-positive women underwent colposcopy-directed biopsies, and thermal ablation treatment if eligible per WHO guidelines. Women with biopsy-confirmed CIN2/3 had colposcopy-directed biopsies at 12-months to determine treatment efficacy. RESULTS: Sixty-eight hrHPV-positive WLWH with biopsy-confirmed CIN2/3 at baseline; 14 CIN2, 54 CIN3, underwent thermal ablation. Mean age and parity were 41.2 years and 4, respectively. The mean CD4 count was 473.98 cells/mm3 and 96.9% had HIV viral suppression. Fifty-eight women (83.8%) have been seen for a 12-month follow-up visit, and pathology results are available for 54 (79.4%). Of these, 35 (66.0%) had successful treatment, defined as biopsy-confirmed CIN1 or normal findings 12-months following treatment, while 18 (34.0%) had treatment failure - persistent biopsy-confirmed CIN2/3. Treatment failure was 23.1% 95% CI (13.0 to 45.9) and 37.5%, 95% CI (22.1 to 52.0) among women with CIN2 and CIN3 at baseline, respectively. CONCLUSION: Hand-held thermal ablation devices are affordable, portable, easy to use, and hence highly scaleable within screen-and-treat programs in LMICs. However, our preliminary results, with rigorous disease status verification at both baseline and follow-up find higher than previously reported treatment failure rates for CIN3 among WLWH, a high-risk population for cervical cancer. If replicated by larger studies, this highlights a potential limitation of the current WHO cervical cancer elimination strategy, calling for better risk stratification in this population, and/or consideration of adjuvant therapy to prevent CIN2/3 recurrence following thermal ablation. |
format | Online Article Text |
id | pubmed-9906534 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Wolters Kluwer Health |
record_format | MEDLINE/PubMed |
spelling | pubmed-99065342023-02-10 Efficacy of Thermal Ablation for Treatment of High-Grade Cervical Dysplasia Among HIV-Positive Women: Preliminary Results From Western Kenya Mungo, Chemtai Ogollah, Cyrillus Ambaka, Jennifer Omoto, Jackton Cohen, Craig JCO Glob Oncol MEETING PROCEEDINGS In 2019, the World Health Organization (WHO) endorsed thermal ablation (TA) for use within “screen-and-treat” cervical cancer prevention programs in low- and middle-income countries (LMICs), including among women living with HIV (WLWH). We evaluated TA efficacy for treatment of biopsy-confirmed cervical intraepithelial neoplasia grades 2 and 3 (CIN2/3) among WLWH in western Kenya (ClinicalTrials.gov NCT04191967). METHODS: Between August 2019 and November 2020, WLWH age 25-65 years underwent high-risk human papillomavirus (hrHPV) self-collection. hrHPV-positive women underwent colposcopy-directed biopsies, and thermal ablation treatment if eligible per WHO guidelines. Women with biopsy-confirmed CIN2/3 had colposcopy-directed biopsies at 12-months to determine treatment efficacy. RESULTS: Sixty-eight hrHPV-positive WLWH with biopsy-confirmed CIN2/3 at baseline; 14 CIN2, 54 CIN3, underwent thermal ablation. Mean age and parity were 41.2 years and 4, respectively. The mean CD4 count was 473.98 cells/mm3 and 96.9% had HIV viral suppression. Fifty-eight women (83.8%) have been seen for a 12-month follow-up visit, and pathology results are available for 54 (79.4%). Of these, 35 (66.0%) had successful treatment, defined as biopsy-confirmed CIN1 or normal findings 12-months following treatment, while 18 (34.0%) had treatment failure - persistent biopsy-confirmed CIN2/3. Treatment failure was 23.1% 95% CI (13.0 to 45.9) and 37.5%, 95% CI (22.1 to 52.0) among women with CIN2 and CIN3 at baseline, respectively. CONCLUSION: Hand-held thermal ablation devices are affordable, portable, easy to use, and hence highly scaleable within screen-and-treat programs in LMICs. However, our preliminary results, with rigorous disease status verification at both baseline and follow-up find higher than previously reported treatment failure rates for CIN3 among WLWH, a high-risk population for cervical cancer. If replicated by larger studies, this highlights a potential limitation of the current WHO cervical cancer elimination strategy, calling for better risk stratification in this population, and/or consideration of adjuvant therapy to prevent CIN2/3 recurrence following thermal ablation. Wolters Kluwer Health 2022-05-05 /pmc/articles/PMC9906534/ http://dx.doi.org/10.1200/GO.22.40000 Text en © 2022 by American Society of Clinical Oncology https://creativecommons.org/licenses/by/4.0/Licensed under the Creative Commons Attribution 4.0 License http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) |
spellingShingle | MEETING PROCEEDINGS Mungo, Chemtai Ogollah, Cyrillus Ambaka, Jennifer Omoto, Jackton Cohen, Craig Efficacy of Thermal Ablation for Treatment of High-Grade Cervical Dysplasia Among HIV-Positive Women: Preliminary Results From Western Kenya |
title | Efficacy of Thermal Ablation for Treatment of High-Grade Cervical Dysplasia Among HIV-Positive Women: Preliminary Results From Western Kenya |
title_full | Efficacy of Thermal Ablation for Treatment of High-Grade Cervical Dysplasia Among HIV-Positive Women: Preliminary Results From Western Kenya |
title_fullStr | Efficacy of Thermal Ablation for Treatment of High-Grade Cervical Dysplasia Among HIV-Positive Women: Preliminary Results From Western Kenya |
title_full_unstemmed | Efficacy of Thermal Ablation for Treatment of High-Grade Cervical Dysplasia Among HIV-Positive Women: Preliminary Results From Western Kenya |
title_short | Efficacy of Thermal Ablation for Treatment of High-Grade Cervical Dysplasia Among HIV-Positive Women: Preliminary Results From Western Kenya |
title_sort | efficacy of thermal ablation for treatment of high-grade cervical dysplasia among hiv-positive women: preliminary results from western kenya |
topic | MEETING PROCEEDINGS |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9906534/ http://dx.doi.org/10.1200/GO.22.40000 |
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