Equal prevalence of severe cervical dysplasia by HPV self-sampling and by midwife-collected samples for primary HPV screening: a randomised controlled trial.
Journal
European journal of cancer prevention : the official journal of the European Cancer Prevention Organisation (ECP)
ISSN: 1473-5709
Titre abrégé: Eur J Cancer Prev
Pays: England
ID NLM: 9300837
Informations de publication
Date de publication:
01 07 2021
01 07 2021
Historique:
pubmed:
20
5
2021
medline:
20
4
2022
entrez:
19
5
2021
Statut:
ppublish
Résumé
HPV self-sampling is an option for cervical screening. The aim of this randomised study was to investigate the compliance, prevalence of HPV, and prevalence of severe dysplasia in a vaginal self-sampling group in comparison to cervical samples collected by midwives (control arm). The hypothesis was that there would be no difference between vaginal self-sampling and cervical sampling to find high-grade cervical dysplasia or cancer. Vaginal HPV self-sampling kits were sent by regular mail to 14 765 randomly selected women aged 30-64 years old in the screening programme. HPV-positive women were invited for a follow-up examination by their midwife in which they provided a cervical sample for cytological and HPV co-testing. The control arm consisted of 14 839 women who met the same inclusion criteria and were invited to have cervical sampling by midwives for primary HPV screening. All HPV samples were analysed by the Aptima HPV assay (Hologic Inc.). The participation rate was 33.5% in the self-sampling arm and 47.5% in the cervical sampling arm, (P < 0.0001). HPV was detected in 17.1% (95% confidence interval (CI), 16.1-18.23%) in the self-sampling arm and 4.5% (95% CI, 4.0-5.0%) in the cervical sampling arm. Histological, severe dysplasia was observed among 0.48% (95% CI, 0.3-0.72%) and 0.47% (95% CI, 0.3-0.66%) of the self-sampling and the cervical sampling groups, respectively. The self-sampling approach detects a similar proportion of severe dysplasia as regular screening. Thus, our study indicates that self-sampling could replace primary HPV screening of cervical samples.
Identifiants
pubmed: 34010238
doi: 10.1097/CEJ.0000000000000693
pii: 00008469-202107000-00008
doi:
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
334-340Informations de copyright
Copyright © 2021 Wolters Kluwer Health, Inc. All rights reserved.
Références
Aarnio R II, Sanner K, Gustavsson IM, Gyllensten UB, Olovsson M. Comparison of vaginal self-sampling and cervical sampling by medical professionals for the detection of HPV and CIN2+ : a randomized study. Int J Cancer:. 148:3051–3059. [Accessed 17 April 2020]
Aitken CA, van Agt HME, Siebers AG, van Kemenade FJ, Niesters HGM, Melchers WJG, et al. (2019). Introduction of primary screening using high-risk HPV DNA detection in the Dutch cervical cancer screening programme: a population-based cohort study. BMC Med. 17:228.
Alfonzo E, Andersson Ellström A, Nemes S, Strander B (2016). Effect of fee on cervical cancer screening attendance–screenfee, a Swedish population-based randomised trial. PLoS One. 11:e0150888.
Andrae B, Kemetli L, Sparén P, Silfverdal L, Strander B, Ryd W, et al. (2008). Screening-preventable cervical cancer risks: evidence from a nationwide audit in Sweden. J Natl Cancer Inst. 100:622–629.
Arbyn M, Smith SB, Temin S, Sultana F, Castle P; Collaboration on Self-Sampling and HPV Testing (2018). Detecting cervical precancer and reaching underscreened women by using HPV testing on self samples: updated meta-analyses. BMJ. 363:k4823.
Arbyn M, Weiderpass E, Bruni L, de Sanjosé S, Saraiya M, Ferlay J, Bray F (2020). Estimates of incidence and mortality of cervical cancer in 2018: a worldwide analysis. Lancet Glob Health. 8:e191–e203.
Asciutto KC, Ernstson A, Forslund O, Borgfeldt C (2018). Self-sampling with HPV mRNA analyses from vagina and urine compared with cervical samples. J Clin Virol. 101:69–73.
Asciutto KC, Henningsson AJ, Borgfeldt H, Darlin L, Borgfeldt C (2017). Vaginal and urine self-sampling compared to cervical sampling for HPV-testing with the Cobas 4800 HPV Test. Anticancer Res. 37:4183–4187.
Basu P, Banerjee D, Mittal S, Dutta S, Ghosh I, Chowdhury N, et al. (2016). Sensitivity of APTIMA HPV E6/E7 mRNA test in comparison with hybrid capture 2 HPV DNA test for detection of high risk oncogenic human papillomavirus in 396 biopsy confirmed cervical cancers. J Med Virol. 88:1271–1278.
Borgfeldt C, Forslund O (2019). Increased HPV detection by the use of a pre-heating step on vaginal self-samples analysed by Aptima HPV assay. J Virol Methods. 270:18–20.
Bosch FX, Lorincz A, Muñoz N, Meijer CJ, Shah KV (2002). The causal relation between human papillomavirus and cervical cancer. J Clin Pathol. 55:244–265.
Bosgraaf RP, Verhoef VM, Massuger LF, Siebers AG, Bulten J, de Kuyper-de Ridder GM, et al. (2015). Comparative performance of novel self-sampling methods in detecting high-risk human papillomavirus in 30,130 women not attending cervical screening. Int J Cancer. 136:646–655.
Chernesky M, Jang D, Gilchrist J, Elit L, Lytwyn A, Smieja M, et al. (2014). Evaluation of a new APTIMA specimen collection and transportation kit for high-risk human papillomavirus E6/E7 messenger RNA in cervical and vaginal samples. Sex Transm Dis. 41:365–368.
Cuzick J, Cadman L, Mesher D, Austin J, Ashdown-Barr L, Ho L, et al. (2013). Comparing the performance of six human papillomavirus tests in a screening population. Br J Cancer. 108:908–913.
Cuzick J, Clavel C, Petry KU, Meijer CJ, Hoyer H, Ratnam S, et al. (2006). Overview of the European and North American studies on HPV testing in primary cervical cancer screening. Int J Cancer. 119:1095–1101.
Darlin L, Borgfeldt C, Forslund O, Hénic E, Dillner J, Kannisto P (2013). Vaginal self-sampling without preservative for human papillomavirus testing shows good sensitivity. J Clin Virol. 56:52–56.
Dillner J, Strander B, Sparén P. Förebyggande av livmoderhalscancer i Sverige - Verksamhetsberättelse och Årsrapport 2018 med data till och med 2017. [Prevention of Cervical Cancer in Sweden - Activity Report and Annual Report 2018 with data up to and including 2017]. In: Swedish. Nationellt Kvalitetsregister för Cervixcancerprevention [Swedish National Cervical Screening Registry]. Stockholm. 2018. https://nkcx.se/templates/_rsrapport_2018.pdf . [Accessed 20 March 2020]
Enerly E, Bonde J, Schee K, Pedersen H, Lönnberg S, Nygård M (2016). Self-sampling for human papillomavirus testing among non-attenders increases attendance to the Norwegian cervical cancer screening programme. PLoS One. 11:e0151978.
Ernstson A, Urdell A, Forslund O, Borgfeldt C (2020). Cervical cancer prevention among long-term screening non-attendees by vaginal self-collected samples for hr-HPV mRNA detection. Infect Agent Cancer. 15:10.
Gök M, Heideman DA, van Kemenade FJ, Berkhof J, Rozendaal L, Spruyt JW, et al. (2010). HPV testing on self collected cervicovaginal lavage specimens as screening method for women who do not attend cervical screening: cohort study. BMJ. 340:c1040.
Gök M, van Kemenade FJ, Heideman DA, Berkhof J, Rozendaal L, Spruyt JW, et al. (2012). Experience with high-risk human papillomavirus testing on vaginal brush-based self-samples of non-attendees of the cervical screening program. Int J Cancer. 130:1128–1135.
Gustavsson I, Aarnio R, Berggrund M, Hedlund-Lindberg J, Strand AS, Sanner K, et al. (2018). Randomised study shows that repeated self-sampling and HPV test has more than two-fold higher detection rate of women with CIN2+ histology than Pap smear cytology. Br J Cancer. 118:896–904.
Hope KA, Moss E, Redman CWE, Sherman SM (2017). Psycho-social influences upon older women’s decision to attend cervical screening: A review of current evidence. Prev Med. 101:60–66.
Kellen E, Benoy I, Vanden Broeck D, Martens P, Bogers JP, Haelens A, Van Limbergen E (2018). A randomized, controlled trial of two strategies of offering the home-based HPV self-sampling test to non- participants in the Flemish cervical cancer screening program. Int J Cancer. 143:861–868.
Lindroth Y, Borgfeldt C, Thorn G, Bodelsson G, Forslund O (2019). Population-based primary HPV mRNA cervical screening compared with cytology screening. Prev Med. 124:61–66.
Regionala cancercentrum i samverkan (2019). Nationellt vårdprogram för livmoderhalscancerprevention [Internet]. Regionala cancercentrum i samverkan. [Cited 2020 March 10]. https://kunskapsbanken.cancercentrum.se/diagnoser/livmoderhalscancerprevention/vardprogram/ . [Accessed 10 March 2020]
Swedish National Cervical Screening Registry (2020). Nationellt Kvalitetsregister för Cervixcancerprevention. Stockholm. http://www.nkcx.se . [Accessed 9 May 2021]
Stenvall H, Wikström I, Wilander E (2007). High prevalence of oncogenic human papilloma virus in women not attending organized cytological screening. Acta Derm Venereol. 87:243–245.