Significant Cervical Squamous Lesions (CIN2/3) in the Follow-Up of Women with Liquid-Based (Surepath) Pap Tests Interpreted as Atypical Cells of Undetermined Significance: Impact of Changes in Diagnostic Criteria and HPV Vaccination.
Shelly M Cook, Roberto G Gamez, Linjun Xie, Jana Holler, Stefan E Pambuccian, Evin H Gulbahce. University of Minnesota, Minneapolis
Background: The main purpose of identifying atypical squamous cells of undetermined significance (ASCUS) in Pap tests is to identify and treat potential underlying significant cervical carcinoma precursor lesions (CIN2/3).
The aim of this study was to determine the impact of the Bethesda 2001 redefinition of ASCUS and the advent of HPV vaccination on the HPV genotypes and follow-up biopsy diagnoses of CIN2/3 of women diagnosed as ASCUS in our low-risk, relatively older, predominantly suburban screening population.
Design: Cases diagnosed as ASCUS that had a reflex HPV DNA test performed by PCR from 01/01/2001 to 6/30/2001 were identified and histologic diagnoses on biopsies performed within 6 months of the Pap diagnosis were collected. The study period was divided into 3 periods, P1=1/1/2001-12/03/2002, the date of the introduction of B2001 in our institution, P2=12/04/2003-6/30/2006, the date of FDA approval of the HPV vaccine Gardasil(r) and P3=07/01/2006-6/30/2009.
Results: There were a total of 18523 patients identified with an ASC-US diagnosis during the study period. The mean age for the 3 groups was 36.51±12.91, 35.14 1±12.89 and 35.52 ±13.76.
|ASC-US||any HPV type (% of all ASC-US)||hr-HPV+ (% of all ASC-US)||HPV16/18 (% of hr-HPV)||Biopsy Rate (% of all ASC-US)||CIN1 (% of all Bx)||CIN2/3+ (% of all ASC-US)|
|P1||2028||552 (27.2%)||277 (13.6%)||207 (74.7%)||529 (26.0%)||132 (24.9%)||68 (3.4%)|
|P2||8636||3215 (37.2%)||1496 (17.3%)||789 (52.7%)||2083 (24.1%)||628 (30.1%)||248 (2.9%)|
|P3||7859||3284 (41.7%)||1666 (21.2%)||721 (.43.2%)||1235 (15.7%)||359 (29.0%)||208 (2.6%)|
|p value*||1,2,3 = <.001||1,2,3 = <.001||1,2,3 = <.001||1=.04, 2,3=<.001||1=.018, 2=.2, 3=.5||1=.2, 2=.09, 3=.4|