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.
CIN
HPV-DNA
HPV-mRNA
cervical cancer screening
invasive cervical cancer
Journal
International journal of cancer
ISSN: 1097-0215
Titre abrégé: Int J Cancer
Pays: United States
ID NLM: 0042124
Informations de publication
Date de publication:
01 06 2020
01 06 2020
Historique:
received:
30
07
2019
revised:
28
08
2019
accepted:
05
09
2019
pubmed:
5
10
2019
medline:
8
1
2021
entrez:
5
10
2019
Statut:
ppublish
Résumé
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.
Substances chimiques
DNA, Viral
0
Papillomavirus E7 Proteins
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
3114-3123Informations de copyright
© 2019 UICC.
Références
World Health Organization. WHO guidelines for screening and treatment of precancerous lesions for cervical cancer prevention. Geneva: World Health Organization, 2013. Update June 2019. Available at. https://www.who.int/reproductivehealth/publications/cancers/screening_and_treatment_of_precancerous_lesions/en/.
von Karsa L, Arbyn MH, Dillner J, et al. European guidelines for quality assurance in cervical cancer screening. Summary of the supplements on HPV screening and vaccination. Papillomavirus Res 2015;1:22-31.
Smith RA, Brooks D, Cokkinides V, et al. Cancer screening in the United States, 2013: a review of current American Cancer Society guidelines, current issues in cancer screening, and new guidance on cervical cancer screening and lung cancer screening. CA Cancer J Clin 2013;63:88-105.
US Preventive Services Task Force, Curry SJ, Krist AH, et al. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA 2018;320:674-86.
Ronco G, Dillner J, Elfström KM, et al. International HPV screening working group. Efficacy of HPV-based screening for prevention of invasive cervical cancer: follow-up of four European randomised controlled trials. Lancet 2014;383:524-32.
Arbyn M, Ronco G, Anttila A, et al. Evidence regarding HPV testing in secondary prevention of cervical cancer. Vaccine 2012;30(Suppl. 5):F88-99.
Cuzick J, Cadman L, Mesher D, et al. Comparing the performance of six human papillomavirus tests in a screening population. Br J Cancer 2013;108:908-13.
Nieves L, Enerson CL, Belinson S, et al. Primary cervical cancer screening and triage using an mRNA human papillomavirus assay and visual inspection. Int J Gynecol Cancer 2013;23:513-8.
Monsonego J, Hudgens MG, Zerat L, et al. Evaluation of oncogenic human papillomavirus RNA and DNA tests with liquid-based cytology in primary cervical cancer screening: the FASE study. Int J Cancer 2011;129:691-701.
Monsonego J, Hudgens MG, Zerat L, et al. Risk assessment and clinical impact of liquid-based cytology, oncogenic human papillomavirus (HPV) DNA and mRNA testing in primary cervical cancer screening (the FASE study). Gynecol Oncol 2012;125:175-80.
Heideman DA, Hesselink AT, van Kemenade FJ, et al. The Aptima HPV assay fulfills the cross-sectional clinical and reproducibility criteria of international guidelines for human papillomavirus test requirements for cervical screening. J Clin Microbiol 2013;51:3653-7.
Iftner T, Becker S, Neis KJ, et al. Head-to-head comparison of the RNA-based Aptima human papillomavirus (HPV) assay and the DNA-based hybrid capture 2 HPV test in a routine screening population of women aged 30 to 60 years in Germany. J Clin Microbiol 2015;53:2509-16.
Giorgi Rossi P, Bisanzi S, Allia E, et al. Determinants of viral oncogene E6-E7 mRNA overexpression in a population-based large sample of women infected by high-risk human papillomavirus types. J Clin Microbiol 2017;55:1056-65.
Forslund O, Miriam Elfström K, Lamin H, et al. HPV-mRNA and HPV-DNA detection in samples taken up to seven years before severe dysplasia of cervix uteri. Int J Cancer 2019;144:1073-81.
Reid JL, Wright TC Jr, Stoler MH, et al. Human papillomavirus oncogenic mRNA testing for cervical cancer screening: baseline and longitudinal results from the CLEAR study. Am J Clin Pathol 2015;144:473-83.
Cook DA, Smith LW, Law JH, et al. Comparative performance of human papillomavirus messenger RNA versus DNA screening tests at baseline and 48 months in the HPV FOCAL trial. J Clin Virol 2018;108:32-7.
Iftner T, Neis KJ, Castanon A, et al. Longitudinal clinical performance of the RNA-based Aptima human papillomavirus (AHPV) assay in comparison to the DNA-based hybrid capture 2 HPV test in two consecutive screening rounds with a 6-year interval in Germany. J Clin Microbiol 2019; 57. pii: e01177-18. doi:https://doi.org/10.1128/JCM.01177-18.
Maggino T, Sciarrone R, Murer B, et al. Screening women for cervical cancer carcinoma with a HPV mRNA test: first results from the Venice pilot program. Br J Cancer 2016;115:525-32.
Arbyn M, Anttila A, Jordan J, et al. European guidelines for quality assurance in cervical cancer screening. Second edition-summary document. Ann Oncol 2010;21:448-58.
Ministero della Salute. Piano Nazionale della Prevenzione 2014-2018. Update June 2019. Available at www.salute.gov.it/imgs/C_17_pubblicazioni_2285_allegato.pdf
Gruppo Italiano Screening Citologico (GISCi). Raccomandazioni sul test HR-HPV come test di screening primario e rivisitazione del ruolo del Pap test. Belluno: Evidenzia, 2010. Update August 2015. Available at. www.gisci.it/documenti/documenti_gisci/documento_hpv.pdf.
Ronco G, Biggeri A, Confortini M, et al. Health technology assessment report: HPV DNA based primary screening for cervical cancer precursors. Epidemiol Prev 2012;36(Suppl. 1):e1-e72.
Zorzi M, Del Mistro A, Farruggio A, et al. Use of a high-risk human papillomavirus DNA test as the primary test in a cervical cancer screening programme: a population-based cohort study. BJOG 2013;120:1260-8.
Solomon D, Davey D, Kurman R, et al. Forum group members; Bethesda 2001 workshop. The 2001 Bethesda system: terminology for reporting results of cervical cytology. JAMA 2002;287:2114-99.
Ronco G, Zappa M, Franceschi S, et al. Impact of variations in triage cytology interpretation on human papillomavirus-based cervical screening and implications for screening algorithms. Eur J Cancer 2016;68:148-55.
Dalla Palma P, Giorgi Rossi P, Collina G, et al. The reproducibility of CIN diagnoses among different pathologists: data from histology reviews from a multicenter randomized study. Am J Clin Pathol 2009;132:125-32.
Zorzi M, Fedato C, Cogo C, et al. I programmi di screening oncologici del Veneto. Padova, Italy: CLEUP 2015. Rapporto 2012-2013. Update June 2019. Available at file:///C:/Users/MANUEL~1/AppData/Local/Temp/Rapporto_Veneto_Screening_2012-2013-1.pdf.