Risk of CIN2 or more severe lesions after negative HPV-mRNA E6/E7 overexpression assay and after negative HPV-DNA test: Concurrent cohorts with a 5-year follow-up

Manuel Zorzi, Annarosa Del Mistro, Paolo Giorgi Rossi, Licia Laurino, Jessica Battagello, Melania Lorio, Marika Soldà, Eva Martinotti Gabellotti, Michela Maran, Antonella Dal Cin, Annarita Fiore, Massimo Rugge, Tiziano Maggino

Research output: Contribution to journalArticle

Abstract

Aim of this study was to compare the 5-year risk of cervical intraepithelial neoplasia grade 2+ (CIN2+)/CIN3+ and the performance parameters at 3-year rescreening of a negative E6/E7 mRNA-human papillomavirus (HPV) test with those of a HPV-DNA-negative test. We studied a cohort of HPV-negative women tested with the Aptima HPV-mRNA Assay (“HPV-mRNA cohort”) versus a cohort of HPV negatives tested with the Hybrid Capture 2 (HC2) DNA test living in neighboring areas. Both cohorts were rescreened after 3 years by a HPV-DNA test (HC2 or Cobas 4800 HPV test). HPV test positivity, referral to colposcopy and detection of CIN2+ at 3-year rescreening were computed. The Veneto Cancer Registry was checked to search for invasive cancers and CIN3 diagnosed up to 5 years from the negative baseline test. Some 22,338 HPV-mRNA and 68,695 HPV-DNA-negative women were invited to 3-year rescreening, and, respectively, 16,641 (74.5%) and 54,630 (79.6%) complied with the invitation. The proportion of HPV-positive tests, referral to colposcopy and detection of CIN2+ in the HPV-mRNA and HPV-DNA cohorts were, respectively. 4.0 and 3.9% (ratio 1.08; 95% confidence interval [CI] 0.99–1.17), 2.6 and 2.5% (ratio 1.06, 95% CI 0.95–1.18) and 1.4 and 1.7‰ (ratio 0.85, 95% CI 0.54–1.33). The relative 5-year cumulative risk of cancer and of CIN2+ in the HPV-mRNA and HPV-DNA cohorts were 4.5 and 8.7/100,000 (ratio 0.51; 95%CI 0.01–4.22) and 1.1 and 1.5/1,000 (ratio 0.74; 95%CI 0.45–1.16), respectively. A negative HPV-mRNA test confers a risk of invasive cervical carcinoma and of CIN2+ at 5 years comparable to that of a negative HPV-DNA test.

Original languageEnglish
JournalInternational Journal of Cancer
DOIs
Publication statusE-pub ahead of print - Oct 3 2019

Keywords

  • cervical cancer screening
  • CIN
  • HPV-DNA
  • HPV-mRNA
  • invasive cervical cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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