학술논문

Value of a catch-up HPV test in women aged 65 and above: A Danish population-based nonrandomized intervention study.
Document Type
Article
Source
PLoS Medicine. 7/6/2023, Vol. 20 Issue 7, p1-17. 17p. 1 Diagram, 4 Charts.
Subject
*HUMAN papillomavirus
*GENITAL warts
*EARLY detection of cancer
*CERVICAL intraepithelial neoplasia
*MEDICAL screening
*OLDER women
Language
ISSN
1549-1277
Abstract
Background: High-risk human papillomavirus (HPV) test is replacing cytology as the primary cervical cancer screening test due to superior sensitivity, but in most countries women ≥65 years have never had an HPV test despite they account for around 50% of cervical cancer deaths. We explored the effect of a catch-up HPV test among 65- to 69-year-old women without previous record of HPV-based screening. Methods and findings: This population-based nonrandomized intervention study (quasi-experimental design) included Danish women aged 65 to 69 with no record of cervical cancer screening in the last ≥5.5 years and no HPV-exit test at age 60 to 64 at the time of study inclusion. Eligible women residing in the Central Denmark Region were invited for HPV screening either by attending clinician-based sampling or requesting a vaginal self-sampling kit (intervention group, n = 11,192). Women residing in the remaining four Danish regions received standard care which was the opportunity to have a cervical cytology collected for whatever reason (reference group, n = 33,387). Main outcome measures were detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse (CIN2+) per 1,000 women eligible for the screening offer and the benefit–harm ratio of the intervention and standard practice measured as the number of colposcopies needed to detect one CIN2+ case. The minimum follow-up time was 13 months for all tested women (range: 13 to 25 months). In the intervention group, 6,965 (62.2%) were screened within 12 months from the date of study inclusion and 743 (2.2%) women had a cervical cytology collected in the reference group. The CIN2+ detection was significantly higher in the intervention group (3.9, 95% confidence interval (CI): [2.9, 5.3]; p < 0.001; n = 44/11,192) as compared to the reference group (0.3, 95% CI: [0.2, 0.6]; n = 11/33,387). For the benefit–harm ratio, 11.6 (95% CI: [8.5, 15.8]; p = 0.69; n = 511/44) colposcopies were performed to detect one CIN2+ in the intervention group as compared to 10.1 (95% CI: [5.4, 18.8]; n = 111/11) colposcopies in the reference group. The study design entails a risk of confounding due to the lack of randomization. Conclusions: The higher CIN2+ detection per 1,000 eligible women in the intervention group supports that a catch-up HPV test could potentially improve cervical cancer prevention in older women. This study informs the current scientific debate as to whether women aged 65 and above should be offered a catch-up HPV test if they never had an HPV test. Trial registration: ClinicalTrials.gov NCT04114968. In a population based cohort study, Mette Tranberg and colleagues investigate the value of catch-up HPV testing in more than 45,000 eligible women from Denmark aged over 65 years. Author summary: Why was this study done?: Recommendations on cervical cancer screening at older ages are mainly based on expert opinions and modeling studies rather than empirical evidence. High-risk human papillomavirus (HPV) test is replacing cytology as the primary cervical cancer screening test due to superior sensitivity, but in most countries women over 65 years have never had an HPV test and controversy remains on whether and how these women should be offered a catch-up HPV test to prevent cancer at older ages. Observational studies have shown only that women who have been insufficiently screened at age 50 to 64 could benefit from continued screening after the age of 65 but evidence on the optimal screening tool to reach insufficiently screened women above 65 is missing. What did the researchers do and find?: This population-based study including a total of 44,579 women showed that a catch-up HPV screening intervention, with the opportunity to choose between clinician-based sampling and vaginal self-sampling, was associated with significantly higher detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse (CIN2+) per 1,000 eligible women as compared to women not offered screening. This study demonstrated that women who have been insufficiently screened at age 50 to 64 (≤1 cytology sample) had higher HPV prevalence and tended to have more CIN2+ lesions diagnosed as compared to sufficiently screened women (≥2 cytology samples). Insufficiently screened women were more likely to undergo vaginal self-sampling as compared to sufficiently screened women, which supports that this screening modality might be ideal to identify older women at risk of cervical cancer. What do these findings mean?: Evidence presented in this study suggests that a catch-up HPV screening intervention could potentially improve cervical cancer prevention in women aged ≥65. Going forward, longer follow-up of the screened women will show if the intervention results in fewer cervical cancer cases and deaths. Policy makers should consider whether HPV catch-up screening interventions should be differentiated depending on previous screening participation and results to reach an appropriate cost-benefit balance. [ABSTRACT FROM AUTHOR]