Diagnosis of Condyloma Acuminatum and Vulvar and Vaginal Squamous Intraepithelial Lesions Correlated with HPV 6/11 Detection: Comparison Between a Commercial Central Laboratory and an Expert Pathology Panel

摘要

Agreement on the diagnosis of non-cervical genital lesions, including vulvar condyloma acuminatum and vulvar and vaginal intraepithelial neoplasia (VIN and VAIN), has rarely been systematically evaluated. Diagnosis of condylo-mas and the low-grade forms of the intraepithelial lesions (VIN 1, VAIN 1) can be difficult due to subtle histologic findings and minimal koilocytosis. Previous studies have shown that HPV 6 and 11 are the predominant types detected in condyloma acuminatum, whereas high-risk types are frequently found in both low-grade and high-grade VIN and VAIN. Combined data from two randomized controlled trials on GARDASIL? were used to evaluate agreement for diagnoses of non-cervical genital lesions made by an expert pathology panel compared with those made by a commercial pathology laboratory and to correlate diagnoses with HPV type. The higher prevalence of HPV 6/11 in condyloma acuminatum and lower prevalence of HPV 6/11 in VAIN 1 and VIN 1 as diagnosed by the expert panel compared with the commercial laboratory are in closer keeping with previous data regarding the expected prevalence of these low-risk HPV types in these lesions. These data suggest that using consensus diagnoses generated by an expert panel for classifying these lesions provides better correlation of HPV type prevalence with diagnosis and is important for adjudicating diagnoses for clinical trials.