Background HPV FOCAL Study is a randomised trial evaluating the efficacy of high risk-HPV DNA (hr-HPV) testing, with Liquid Based Cytology (LBC) triage testing of hr-HPV positives, compared to LBC testing alone (with triage hr-HPV testing for ASCUS positives) in an organised screening programme. Round 1 age specific results comparing differences in screen detection rates between women < 35 yrs vs ≥ 35 yrs are presented.
Methods Between January 2008 and May 2012, 25,243 consented women aged 25 to 65 were randomised to receive either: primary hr-HPV testing (HPV arms) or primary LBC testing (Control arm). Samples obtained with ThinPrep® LBC. HPV testing performed with Qiagen Hybrid Capture 2® High-Risk HPV DNA Test.
Results Data is presented for 21,985 participants enrolled as of July 1, 2011 who had completed Round 1 follow-up procedures by February 20, 2012. Overall, detection rates for CIN3+ were not statistically different between the HPV arm (7.8/1000; 95% CI: 6.1, 9.6) and the control arm (4.9/1000; 95% CI: 3.3, 6.5) when women of all ages were evaluated. In women ≥ 35yrs, the overall detection rate for CIN2+ and CIN3+ were both significantly higher in the HPV arm compared to the control arm (CIN2+: 9.9/1000 vs. 5.1/1000 respectively)(CIN3+: 4.4/1000 vs. 2.0/1000 respectively). For women < 35 yrs, HPV testing detected more CIN2+ and CIN3+ than LBC, but this did not achieve statistical significance. Overall, colposcopy referrals were higher in the HPV testing arm vs. control arm (59.1/1000, vs. 31.5/1000). HPV testing in < 35 yrs referred significantly more women to colposcopy than cytology (153.2/1000 vs. 73.3/1000).
Conclusion HPV screening with cytology triage detects significantly more CIN2+ lesions in women ≥ 35 years than LBC alone in the first round of screening. In women < 35, there was no difference in detection rates, but overall, HPV primary screening resulted in higher colposcopy rates.
- cervical cancer screening
- primary HPV screening
- randomized trial
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.