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Long term duration of protective effect for HPV negative women: follow-up of primary HPV screening randomised controlled trial
- Source :
- The BMJ
- Publication Year :
- 2014
-
Abstract
- Objectives To assess whether the increased sensitivity of screening for human papillomavirus (HPV) may represent overdiagnosis and to compare the long term duration of protective effect against cervical intraepithelial neoplasia grade 2 or worse (CIN2+) in HPV based and cytology based screening. Design 13 year follow-up of the Swedescreen randomised controlled trial of primary HPV screening. Setting Organised cervical screening programme in Sweden. Participants 12 527 women aged 32-38 attending organised screening were enrolled and randomised to HPV and cytology double testing (intervention arm, n=6257) or to cytology only, with samples frozen for future HPV testing (control arm, n=6270). Main outcome measures Cumulative incidence of CIN2+ and CIN3+ (Kaplan Meier curves). Longitudinal test characteristics were calculated for cytology only, HPV testing only, and cytology and HPV testing combined, adjusting for censoring. Results The increased detection of CIN2+ in the intervention arm decreased over time. After six years, the cumulative incidence of CIN3+ was similar in both trial arms, and after 11 years the cumulative incidence of CIN2+ became similar in both arms. The longitudinal sensitivity of cytology for CIN2+ in the control arm at three years was similar to the sensitivity of HPV testing in the intervention arm at five years of follow-up: 85.94% (95% confidence interval 76.85% to 91.84%) v 86.40% (79.21% to 91.37%). The sensitivity of HPV screening for CIN3+after five years was 89.34% (80.10% to 94.58%) and for cytology after three years was 92.02% (80.59% to 96.97%). Conclusions Over long term follow-up, the cumulative incidence of CIN2+ was the same for HPV screening and for cytology, implying that the increased sensitivity of HPV screening for CIN2+ reflects earlier detection rather than overdiagnosis. The low long term risks of CIN3+ among women who tested negative in HPV screening, support screening intervals of five years for such women. Trial registration Clinicaltrials.gov NCT00479375.
- Subjects :
- Oncology
Adult
medicine.medical_specialty
Uterine Cervical Neoplasms
Cervical intraepithelial neoplasia
law.invention
Diagnosis, Differential
Young Adult
Randomized controlled trial
law
Internal medicine
Medicine
Humans
Mass Screening
Papillomaviridae
Young adult
Overdiagnosis
Cervix
Mass screening
Neoplasm Staging
Retrospective Studies
Gynecology
Cervical cancer
Sweden
Vaginal Smears
biology
business.industry
Research
Incidence
Papillomavirus Infections
virus diseases
Reproducibility of Results
General Medicine
Middle Aged
biology.organism_classification
medicine.disease
Uterine Cervical Dysplasia
female genital diseases and pregnancy complications
medicine.anatomical_structure
DNA, Viral
Female
business
Follow-Up Studies
Subjects
Details
- ISSN :
- 17561833
- Volume :
- 348
- Database :
- OpenAIRE
- Journal :
- BMJ (Clinical research ed.)
- Accession number :
- edsair.doi.dedup.....e5cf7e52784d66003e724283def14fbc