297 LIBUSE trial – algorithm for cervical cancer screening with usage of HPV DNA testing with HPV 16/18 genotyping and p16/Ki-67 dual-stained cytology

Introduction/Background* The incidence and mortality of cervical cancer in the Czech Republic remains stable over more than 30 years irrespective of existing national screening based on annual collecting of Pap smears. The aim of our prospective trial was to evaluate the role of HPV DNA testing with 16/18 genotyping and triage with p16/Ki-67 immunocytochemistry. Methodology Women between 30 and 60 years who had in 12 collaborating centres regular annual Pap smear were co-tested in 3 years interval for HPV DNA with selective 16/18 genotyping (Cobas 4800, Roche). All HPV 16/18 positive cases and/or those with severe abnormality in cytology were directly refered to colposcopy; HPV non-16/18 positive cases and LSILs were triaged using p16/Ki-67 dual-stained cytology (CINtec Plus, Roche) and positive cases were refered to colposcopy. Result(s)* Altogether 2407 patiens were eligible for analysis. Mean age of subjects was 43 years. The first round showed 8 cases with severe and 105 cases with mild Pap smear abnormalities. There were 7.4% (180/2418) patients with HPV positivity, out of them 50 had HPV 16 and/or 18. Triage using p16/Ki-67 was positive in 22.5% cases (29/129). After 2 years of follow-up biopsy confirmed 38 HSILs and 2 glandular lesions, all of them were HPV positive. Conclusion* Screening based on HPV testing with selective 16/18 genotyping and p16/Ki-67 triage proved during three years four times more high-grade lesions including glandular lesions than standard screening based on Pap smears.