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  • 2022-RA-1253-ESGO CONCERVE study demonstrates that clinical regression of high-grade cervical intraepithelial neoplasia is associated with absence of FAM19A4/miR124–2 DNA methylation

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Cervical cancer
2022-RA-1253-ESGO CONCERVE study demonstrates that clinical regression of high-grade cervical intraepithelial neoplasia is associated with absence of FAM19A4/miR124–2 DNA methylation
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  1. Nienke van Trommel1,
  2. Wieke Kremer2,
  3. Stèfanie Dick2,
  4. Danielle Heideman2,
  5. Renske Steenbergen2,
  6. Maaike Bleeker2,
  7. Harold Verhoeve3,
  8. Marchien van Baal4,
  9. Gemma Kenter5,
  10. Chris Meijer2 and
  11. Johannes Berkhof6
  1. 1Gynecologic Oncology, Antoni van Leeuwenhoek/Netherlands Cancer Institute, Amsterdam, Netherlands
  2. 2Pathology, Amsterdam UMC, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, Netherlands
  3. 3Obstetrics and Gynaecology, OLVG, Amsterdam, Netherlands
  4. 4Obstetrics and Gynaecology, Flevoziekenhuis, Almere, Netherlands
  5. 5Gynaecologic Oncology, Center of Gynaecologic Oncology Amsterdam, Location Amsterdam UMC, Amsterdam, Netherlands
  6. 6Epidemiology and Data Science, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands

Abstract

Introduction/Background Cervical screening can prevent cancer by detection and treatment of cervical intraepithelial neoplasia grade 2 or 3 (CIN2/3). Screening also results in considerable overtreatment possibly causing complications, unnecessary anxiety and costs, and preterm birth because many CIN2/3 lesions show spontaneous regression when left untreated. Therefore there is a clinical need for a test predicting spontaneous regression in CIN2/3 lesions. In this multicenter longitudinal cohort study of women with untreated CIN2/3, the prognostic value of FAM19A4/miR124–2 methylation was evaluated for clinical regression.

Methodology We prospectively followed women with CIN2/3 for 24 months. Surgical excision was replaced by a wait-and-see policy. FAM19A4/miR124–2 methylation was evaluated on all clinician-collected samples and self-collected samples collected at baseline. Every 6 months, human papillomavirus (HPV) testing and cytology were conducted on a clinician-collected sample, and a colposcopic examination was performed by a gynecologist to exclude progression. At 24 months at the final study visit, two biopsies were taken. Clinical regression was defined as histologically confirmed absence of CIN2+ or an HPV-negative clinician-collected sample with normal cytology. Regression incidences were estimated using the Kaplan-Meier method.

Results 80/114 women included were diagnosed with CIN2 and 34/114 with CIN3. During the study, 65.8% of women (75/114) did not receive surgical treatment. Women with a negative FAM19A4/miR124–2 result on the baseline clinician-collected sample showed more clinical regression (74.7%) than women with a positive methylation result (51.4%, P=0.013). Regression in women with a negative FAM19A4/miR124–2 methylation test was highest when cytology was atypical squamous cells of undetermined significance/low-grade squamous intraepithelial lesion (88.4%) or HPV16 was negative (85.1%).

Conclusion • Most women with untreated CIN2/3 and a negative baseline FAM19A4/miR124–2 methylation test showed clinical regression. • Methylation, in combination with cytology or HPV genotyping, can be used to support a wait-and-see policy in women with CIN2/3

https://doi.org/10.1136/ijgc-2022-ESGO.108

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