Evaluation of the intraoperative human papillomavirus test as a marker of early cure at 12 months after electrosurgical excision procedure in women with cervical high-grade squamous intraepithelial lesion: a prospective cohort study

BJOG. 2020 Jan;127(1):99-105. doi: 10.1111/1471-0528.15932. Epub 2019 Sep 25.

Abstract

Objective: To evaluate if the intraoperative human papillomavirus (IOP-HPV) test has the same prognostic value as the HPV test performed at 6 months after treatment of high-grade squamous intraepithelial lesion (HSIL) to predict treatment failure.

Design: Prospective cohort study.

Setting: Barcelona, Spain.

Population: A cohort of 216 women diagnosed with HSIL and treated with loop electrosurgical excision procedure (LEEP).

Methods: After LEEP, an HPV test was performed using the Hybrid Capture 2 system. If this was positive, genotyping was performed with the CLART HPV2 technique. The IOP-HPV test was compared with HPV test at 6 months and with surgical margins.

Main outcome measure: Treatment failure.

Results: Recurrence rate of HSIL was 6%. There was a strong association between a positive IOP-HPV test, a positive 6-month HPV test, positive HPV 16 genotype, positive surgical margins and HSIL recurrence. Sensitivity, specificity, and positive and negative predictive values of the IOP-HPV test were 85.7, 80.8,24.0 and 98.8% and of the HPV test at 6 months were 76.9, 75.8, 17.2 and 98.0%.

Conclusion: Intraoperative HPV test accurately predicts treatment failure in women with cervical intraepithelial neoplasia grade 2/3. This new approach may allow early identification of patients with recurrent disease, which will not delay the treatment. Genotyping could be useful in detecting high-risk patients.

Tweetable abstract: IOP-HPV test accurately predicts treatment failure in women with CIN 2/3.

Keywords: Follow up; human papillomavirus; loop electrosurgical excision procedure; recurrence; squamous intraepithelial lesion.

Publication types

  • Evaluation Study

MeSH terms

  • Adult
  • Alphapapillomavirus
  • Biomarkers, Tumor / metabolism
  • Colposcopy / statistics & numerical data
  • Early Detection of Cancer / methods*
  • Electrosurgery*
  • Female
  • Genotype
  • Human Papillomavirus DNA Tests / methods
  • Humans
  • Image-Guided Biopsy
  • Intraoperative Care / methods
  • Neoplasm Recurrence, Local / virology
  • Papillomavirus Infections / diagnosis*
  • Prospective Studies
  • Sensitivity and Specificity
  • Squamous Intraepithelial Lesions / surgery*
  • Squamous Intraepithelial Lesions / virology
  • Treatment Failure
  • Uterine Cervical Dysplasia / surgery*
  • Uterine Cervical Dysplasia / virology
  • Uterine Cervical Neoplasms / surgery*
  • Uterine Cervical Neoplasms / virology

Substances

  • Biomarkers, Tumor