A number of randomized controlled trials (RCTs) showed that screening with HPV testing, either as co-testing with cytology or as stand-alone test, led to a significant reduction in cervical cancer incidence compared with cytology based screening. However, evidence for a similar efficacy outside of RCTs is still lacking. Here we report on the 11 years follow-up of the Wolfsburg primary HPV screening pilot project (WOLPHSCREEN).
26,624 women were recruited between Feb 2006 and Dec 2016. Participants had to be at least 30 years old, hysterectomy was an exclusion criterion. All underwent co-testing with Pap smear and HR-HPV testing (HC2). Women with normal findings had their next screening round after 5 years, Pap+/HC2+ case were immediately transferred to colposcopy, while cases with discordant findings had repeat testing after 12 months with referral to colposcopy in case of persistent positive findings.
Overall 305 CIN3+ cases were diagnosed, including 31 invasive cervical cancers. The 5 years incidence of CIN3+ was 0.96% (95% CI: 0.85%-1.09%) in the first round and dropped significantly to 0.16% (95% CI: 0.10% - 0.26%) in subsequent screening rounds. The observed decline in cervical cancer incidence was even steeper from 0.1089% (95% CI: 0.07%-0.16%) in the first to 0.0167% (95% CI: 0.00%-0.06%) in subsequent rounds. The vast majority of CIN3+ cases were diagnosed at first colposcopy (277/305). In the second screening round the remaining cancers were explained by failure of screening tests or colposcopy, while the majority of CIN3 were classified as new lesions.
The observed decline of CIN3+ and invasive cervical cancers in WOLPHSCREEN gives proof that significantly better cervical cancer prevention can be achieved with HPV-testing even outside of RCTs.