HPV self-sampling in the follow-up of women after treatment of cervical intra-epithelial neoplasia: A prospective study in a high-income country

Manuela Viviano, Pierre Vassilakos, Ulrike Meyer-Hamme, Lorraine Grangier, Shahzia Lambat Emery, Manuela Undurraga Malinverno, Patrick Petignat, Manuela Viviano, Pierre Vassilakos, Ulrike Meyer-Hamme, Lorraine Grangier, Shahzia Lambat Emery, Manuela Undurraga Malinverno, Patrick Petignat

Abstract

Current follow-up strategy for women after large loop excision of the transformation zone (LLETZ) for cervical intra-epithelial neoplasia (CIN) is burdened by a low compliance. We evaluated the performance of home-based Human Papillomavirus (HPV) self-sampling (Self-HPV) after treatment for CIN with the aim to assess the (i) feasibility and (ii) follow-up compliance. This study took place at the Geneva University Hospitals between May 2016 and September 2020. Women aged 18 years or older, undergoing LLETZ for a biopsy-proven cervical intraepithelial neoplasia grade 1 or worse (CIN1 + ) were invited to participate. Agreement statistics, interpreted according to the scale of κ values, were calculated for Self-HPV and HPV performed by the physician (Dr-HPV). The samples were analyzed using GeneXpert and Cobas. Sample size was calculated to provide a 10% precision to estimate the kappa coefficient. A total of 127 women were included, with a median age of 35 years (interquartile range 30-41 years). There was a substantial agreement between Self-HPV and Dr-HPV using GeneXpert at 6 and 12 months, with a κ value of 0.63 (95%CI: 0.47-0.79) and 0.66 (95%CI: 0.50-0.82), respectively. Up to 9/10 (90%) women who did not come to their follow-up visit did not send their Self-HPV, either. In the follow-up after LLETZ treatment, home-based self-HPV is feasible, with substantial agreement between the two groups, however, concern remains regarding adherence to Self-HPV performance at home and loss to follow-up. The trial was registered on clinicaltrials.gov with the identifier NCT02780960.

Keywords: Cervical cancer; Cervical intraepithelial neoplasia; HPV self-sampling; LLETZ; Screening.

Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

© 2021 The Author(s).

Figures

Fig. 1
Fig. 1
Study flowchart. Women candidates for LLETZ for cervical dysplasia, including those followed at our clinic and those referred to it from gynecologists working in private practice **2 patients sought a second opinion and chose not to be operated at our clinic ***Reasons for which results may not be available include: sample lost between its collection and the analysis and sample not taken by the physician or nurse.
Fig. 2
Fig. 2
HPV clearance over time according to Self-HPV and Dr-HPV (Xpert).

References

    1. International Agency for Research on Cancer. Estimated age-standardized incidence and mortality rates (World) in 2020, worldwide, females, all ages. Globocan. [Online] World Health Organization , 2009. [Cited: 01 20, 2021.] .
    1. Cogliano V., Baan R., Straif K., Grosse Y., Secretan B., Ghissassi F.E. Carcinogenicity of human papillomaviruses. Lancet Oncol. 2005;6(4):204. doi: 10.1016/S1470-2045(05)70086-3.
    1. Bosch F.X., Lorincz A., Muñoz N., Meijer C.J., Shah K.V. The casual relation between human papillomavirus and cervical cancer. J Clin Pathol. 2002;55:244–265.
    1. von Karsa L., Arbyn M., De Vuyst H., Dillner J., Dillner L., Franceschi S., Patnick J., Ronco G., Segnan N., Suonio E., Törnberg S., Anttila A. European guidelines for quality assurance in cervical cancer screening. Summary of the supplements on HPV screening and vaccination. Papillomavirus Res. 2015;1:22–31.
    1. Bigrigg A., Haffenden D.K., Read M.D., Codling B.W., Sheehan A.L. Efficacy and safety of large-loop excision of the transformation zone. Lancet. 1994;343(8888):32–34.
    1. Arbyn M, Sasieni P, Meijer CJ, Clavel C, Koliopoulos G, Dillner J. Chapter 9: clinical applications of HPV testing: a summary of meta-analyses. Vaccine . 2006, 24 (Suppl 3):78-89.
    1. Coupé V.M.H., Berkhof J., Verheijen R.H.M., Meijer C.J.L.M. Cost-effectiveness of human papillomavirus testing after treatment for cervical intraepithelial neoplasia. BJOG. 2007;114(4):416–424.
    1. Kim Y.-T., Lee J.M., Hur S.-Y., Cho C.-H., Kim Y.T., Kim S.C., Kang S.B. Clearance of human papillomavirus infection after successful conization in patients with cervical intraepithelial neoplasia. Int J Cancer. 2010;126(8):1903–1909.
    1. Venturoli S., Ambretti S., Cricca M., Leo E., Costa S., Musiani M., Zerbini M. Correlation of high-risk human papillomavirus genotypes persistence and risk of residual or recurrent cervical disease after surgica treatment. J Med Virol. 2008;80(8):1434–1440.
    1. Prendiville W., Sankaranarayanan R. International Agency for Resarch on Cancer; Lyon, France: 2017. Colposcopy and treatment of cervical prencancer.
    1. Gallwas J., Ditsch N., Hillemanns P., Friese K., Thaler C., Dannecker C. The significance of HPV in the follow-up period after treatment for CIN. Eur J Gynaecol Oncol. 2010;31(1):27–30.
    1. Leguevaque P., Motton S., Decharme A., Soulé-Tholy M., Escourrou G., Hoff J. Predictors of recurrence in high-grade cervical lesions and a plan of management. Eur J Surg Oncol. 2010;36(11):1073–1079.
    1. Ostojic D.V., Vrdoljak-Mozetic D., Stemberger-Papic S., Finderle A., Eminovic S. Cervical cytology and HPV test in follow-up after conisazion or LLETZ. Coll Antropol. 2010;34(1):219–224.
    1. Tan J.H.J., Malloy M.J., Brotherton J.M.L., Saville M. Compliance with follow-up Test of Cure and outcomes after treatment for high-grade cervical intrapeithelial neoplasia in Victoria, Australia. Aust N Z J Obstet Gynaecol. 2020;60(3):433–437.
    1. Catarino R., Vassilakos P., Royannez-Drevard I., Guillot C., Alzuphar S., Fehlmann A., Meyer-Hamme E., Petignat P. Barriers to cervical cancer screening in Geneva (DEPIST study) J Low Gen Tract Dis. 2016;20(2):135–138.
    1. Verdoodt F., Jentschke M., Hillemanns P., Racey C.S., Snijders P.J.F., Arbyn M. Reaching women who do not participate in the regular cervical cancer screening programme by offeirng self-sampling kits: a systematic review and meta-analysis. Eur J Cancer. 2015;51(16):2375–2385.
    1. Penaranda E., Molokwu J., Flores S., Byrd T., Brown L., Shokar N. Women's attittudes toward cervicovaginal self-sampling for high-risk HPV infection on the US-Mexico border. J Lower Gen Tract Dis. 2015;19(4):323–328.
    1. Arbyn M., Verdoodt F., Snijders P.J.F., Verhoef V.M.J., Suonio E., Dillner L., Minozzi S., Bellisario C., Banzi R., Zhao F.-H., Hillemanns P., Anttila A. Accuracy of human papillomavirus testing on self-collected versus clinician-collected samples: a meta-analysis. Lancet Oncol. 2014;15(2):172–183.
    1. Navarria I., Jacot-Guillarmod M. Groupement Romand de la Société Suisse de Gynécologie et Obstétrique. 2010. Recommandations pour la prise en charge des pathologies cervicales. 1ère édition.
    1. Zhao Y.-Q., Chang I.J., Zhao F.-H., Hu S.-Y., Smith J.S., Zhang X., Li S.-M., Bai P., Zhang W.-H., Qiao Y.-L. Distribution of cervical intraepithelial neoplasia on the cervix in Chinese women: pooled analysis of 19 population based screening studies. BMC Cancer. 2015;15(1) doi: 10.1186/s12885-015-1494-4.
    1. Pretorius R.G., Zhang W.-H., Belinson J.L., Huang M.-N., Wu L.-Y., Zhang X., Qiao Y.-L. Colposcopically directed biopsy, random cervical biopsy, and endocervical curettage in te diagnosis of cervical intraepithelial neoplasia II or worse. Am J Obstet Gynecol. 2004;191(2):430–434.
    1. Hoffman S.R., Le T., Lockhart A., Sanusi A., Dal Santo L., Davis M., McKinney D.A., Brown M., Poole C., Willame C., Smith J.S. Patterns of persistent HPV infection after treatment for cervical intraepithelial neoplasia (CIN): a systematic review. Int J Cancer. 2017;141(1):8–23.
    1. Soutter W.P., de Barros L.A., Fletcher A., Monaghan J.M., Duncan I.D., Paraskevaidis E., et al. Invasive cancer after conservative therapy for cervical intraepithelial neoplasia. Lancet. 1997;349:978–980.
    1. Rippinger N., Heinzler J., Bruckner T., Brucker J., Dinkic C., Hoffmann J., Dornhöfer N., Seitz S., Rom J., Sohn C., Schott T.C., Schott S. The impact of a cervical dysplasia diagnosis on individual cancer prevention habits over time: a bicentric case-control study. Arch Gynecol Obstet. 2019;299(3):847–855.
    1. Peeters E., Cornet K., Cammu H., Verhoeven V., Devroey D., Arbyn M. Corrigendum to “Efficacy of strategies to increase participation in cervical cancer screening: GPs offering self-sampling kits for HPV testing versus recommendations to have a pap smear takn - A randomised controlled trial” [Papillomavirus Res (2020) 1001. Papillomavirus Res. 2020;9
    1. So K.A., Lee I.H., Kim T.J., Lee K.H. Risk factors of persistent HPV infection after treatment for high-grade squamous intraepithelial lesion. Arch Gynecol Obstet. 2019;299(1):223–227.
    1. Fargnoli V., Petignat P., Burton-Jeangros C. To what extent will women accept HPV self-sampling for cervical cancer screening? A qualitative study conducted in Switzerland. Int J Womens Health. 2015;7:883–888.
    1. Andersson S., Belkić K., Mints M., Östensson E., Grce M. Is self-sampling to test for high-risk papillomavirus an acceptable option among women who have been treated for high-grade cervical intraepithelial neoplasia? PLoS One. 2018;13(6):e0199038.
    1. Srisuttayasathien M., Manchana T. Adherence to follow-up in women with cervical intraepithelial neoplasia grade 1. Taiwan J Obstet Gynecol. 2021;60(1):56–59.
    1. Catarino R., Vassilakos P., Bilancioni A., Bougel S., Boukrid M., Meyer-Hamme U., Petignat P., Saville M. Accuracy of self-collected vaginal dry swabs using the Xpert human papillomavirus assay. PLoS One. 2017;12(7):e0181905.

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