Risk-adapted primary HPV cervical cancer screening project in Wolfsburg, Germany - Experience over 3 years

Background: Currently, the German cervical cancer screening program encompasses an annual cytological Papanicolaou (Pap) smear. However, primary screening for cervical cancer using human papillomavirus (HPV) DNA testing detects cervical pre-cancerous lesions with a significantly higher sensitivity than the Pap smear-based cytology. Objectives: In order to develop viable modalities for primary cervical screening incorporating DNA testing for high-risk (HR) types of HPV, we started a pilot project in the city of Wolfsburg, Germany, in February 2006. This program provided a risk-adapted HPV testing-based strategy with defined patient pathways and extended screening intervals for women of 30 years or older. We report here the data of a 3-year follow-up. Study design: In the context of the usual routine screening at their office-based gynecologists, women were offered conventional Cytology Plus the Hybrid Capture 2 (HC2) HPV DNA test. Women with inconspicuous cytological findings (Pap I/II) and negative HC2 test were re-tested after 5 years but continued their annual gynecological examinations. When cytology and HC2 were positive, women were immediately referred to colposcopy. In women with a negative cytology but positive HC2 test, Pap smear was repeated after 6 mo and HC2 testing after 12 mo, and women were called for colposcopy if the HC2 test was persistently positive. Results: From February 2006 to December 2008, 16,724 women agreed to participate in the project. Overall, 906 (5.41%) had positive HC2 results and 338 (2.02%) showed atypical Pap smears at recruitment. There were 417 (2.48%) women referred for colposcopy, 104 of whom were diagnosed with cervical intraepithelial neoplasia (ClN)3 or worse, including 8 invasive cancers and 8 adenocarcinoma in situ (ACIS). No case of ClN 3 or worse occurred in HC2 negative women. Conclusions: The presented risk-adapted Wolfsburg Cervical Cancer Prevention Project (Wolfsburg Model) has been shown to be effective and feasible in identifying women at risk and for avoiding unnecessary procedures for those who are double negative, thus allowing longer screening intervals and cost savings. Acceptance rates for the program were high for both participating women and gynecologists. (C) 2009 Elsevier B.V. All rights reserved.