Prognostic Significance of HPV L1 Capsid Protein Detection with Cytoactiv® in an International Multicenter Study of 3000 Early Dysplastic Lesions
R Hilfrich, HG Griesser. Cytoimmun Diagnostics GmbH, Pirmasens, Germany; Center of Pathology and Cytodiagnostics (ZPZ Köln), Cologne, Germany
Background: Data from ALTS confirmed that HPV DNA testing is not a useful triage strategy in low grade SIL (LSIL) and that it is still unresolved if individual cases of cervical intraepithelial neoplasia grade 2 (CIN 2) represent biologically low grade or high grade lesions. We and others have shown the prognostic significance of HPV L1 capsid protein detection with Cytoactiv on HPV high risk (hrHPV) associated mild and moderate dysplastic lesions. (i.e. Griesser et al, AJCP, in Press) In short, hrHPV positive and HPV L1 capsid protein negative,early dysplastic lesions are significantly more likely to progress to histologically confirmed CIN 3 lesions than are L1 positive cases.
Design: The aims of this study are 1.) to validate the prognostic relevance of HPV L1 capsid protein detection for early dysplastic lesions. 2.) to evaluate the impact of different preparation techniques (conventional Pap smear versus FDA approved LBC) on the sensitivity of L1 detection and its prognostic significance.
Results: Until June 2008, study centers located in Germany, USA, Sweden, Italy, Switzerland, and Australia contributed 3000 randomly selected cases of HIV negative, non-pregnant, non HPV L1 vaccinated women reported as LSIL (internationally) or in Germany as group IIID with subclassification into mild (LSIL) or moderate (HSIL) dysplasia. Follow up will be until June 2010. 53-85% of the LSIL and 23-50% of the HSIL cases have been positive for L1 capsid protein detection.
Conclusions: L1 positive mild and moderate dysplasias, reflecting productive HPV infection, showed a low risk of progression. L1 negative early dysplastic lesions, as non-productive infections or precancerous lesions, showed a high progression rate, as high as expected for severe dysplasias / squamous carcinoma in-situ.
Tuesday, March 23, 2010 11:00 AM
Platform Session: Section F, Tuesday Morning