[451] Follow-Up Outcomes of a Large Cohort of Low-Risk Patients with Negative Imaged Liquid-Based Cytology and Negative HPV Test Results

Baoying Weng, Marshall R Austin, Zaibo Li, Huaitao Yang, Mona Bansal, Chengquan Zhao. Magee-Womens Hospital, UPMC, Pittsburgh, PA; Conemaugh Valley Memorial Hospital, Johnstown, PA

Background: Concurrent testing for HPV and cytology (co-testing) is an FDA-approved cervical screening alternative for women 30 years and older. The objective of this study was to document the development of significant cervical disease over time in a large cohort of low risk women with “double-negative” co-test results.
Design: The CoPath database was searched from July 2005 to June 2006 to retrieve cases with both negative hrHPV and cytology results. hrHPV testing used the HC2 assay. Pap tests were LBC ThinPrep specimens screened utilizing computer-assisted screening. Pap, histologic, and repeat HPV test follow-up results were recorded and analyzed.
Results: Double-negative cotest results were identified in 4112 women, and 3211 had recorded histopathologic and/or cytological follow-up results. The average age of the women was 46.8 years (15-87). The average follow-up period was 44 months (1-69). Histopathologic and cytologic follow-up results are shown in Table 1.

Summary of Follow-up Results

Follow-upMethod(s)	Total Case#	Glandular neoplasia*	CIN2/3/HSIL#	CIN1/LSIL	CIN/SIL
Histology	549	6	5 (0.9)	50 (9.1)	55 (10.0)
Cytology only	2662	0	1 (0.04)	24 (0.9)	25 (0.9)
Total	3211	6 (0.2)	6 (0.2)	74 (2.3)	80 (2.5)

*Includes diagnoses of one AIS, one invasive cervical adenocarcinoma, and four endometrial carcinomas. #One CIN3 with microinvasion

The average follow-up period for cases with CIN2/3 diagnoses was 36.6 months (11-64). The average follow-up period to an initial Pap test was 24 months (1-68). 2023 women with had repeat HPV testing and 107 (5.3%) had hrHPV-positive results.

Repeat HPV testing result

HPV testing	Case No	%
Positive only	56	2.8
Negative only	1916	94.7
Both positive and negative	51	2.5
Total	2023	100

An initial repeat hrHPV test was positive in 89 of 2023 (4.4%) patients. The average follow-up interval to an initial repeat hrHPV test was 31 months (1-69) and 34 months (5-69) to an initial repeat positive hrHPV test.
Conclusions: 3211 women who were negative by both cytology and HPV testing had histologic and/or Pap follow-up results over an average follow-up period of 44 months. Two patients were diagnosed with cervical carcinomas. High grade cervical intraepithelial neoplasia was diagnosed in seven patients. The risk of developing cervical high grade neoplasia for women with double negative co-testing results is very low. Our result also indicated that the "3-year screening intervals" guideline was not strictly followed in clinical practice for this study group.
Category: Cytopathology

Tuesday, March 20, 2012 2:00 PM

Platform Session: Section C, Tuesday Afternoon