Efficacy of HPV Testing in Predicting CIN2+ in Women with an Unsatisfactory Pap Cytology Result

S28 the role of HPV testing as a primary screening modality remains controversial. An important clinical value of HPV testing is its high sensitivity. However, recent studies have challenged previously reported data. Our study aims to evaluate the sensitivity of HPV testing at our institution. Materials and Methods: A search was done for all HSIL Pap tests from January 1, 2011 through December 31, 2014. The samples included SurePath and ThinPrep preparations. Data from surgical follow-up and concurrent HPV testing was collected and analyzed. High risk HPV testing was performed utilizing Digene Hybrid Capture 2. Results: HSIL Pap test results were identified in 107 of 13,325 cases (0.8%). 58 (54%) had surgical follow-up of CIN2+. Of the biopsyconfirmed HSIL cases, 18 (31%) had a concurrent HPV test. The 18 Pap tests were from 17 patients. There were 14 (78%) cases with a positive HPV result and 4 (22%) with a negative HPV result. Of the 4 cases with a negative HPV result, surgical follow-up included 1 case of CIN 3, 1 case of CIN 2, and 1 case of VaIN 2. The patient with the VaIN 2 biopsy had 2 previous HSIL Pap tests, both with negative HPV results. The biopsies from cases with a concurrent negative HPV result were blindly reviewed and confirmed by four pathologists. Conclusion: The sensitivity of HPV testing at our institution was lower than that reported in the literature. 22% of women with HSIL would have been misdiagnosed with HPV only screening. These findings are an important quality assurance measure and support the need for cytology co-testing. 53 Follow-Up of HSIL/hrHPV Negative Co-Testing Indicates Intermediate Risk for Subsequent HSIL Histology Jennifer Sauter, MD, Gary Keeney, MD, Colleen Schafer, SCT(ASCP), Michael Henry, MD Mayo Clinic and Foundation, Rochester, Minnesota Introduction: A high-grade squamous intraepithelial lesion (HSIL) cytology result that is high-risk human papillomavirus (HPV) negative is unusual. This study reviews the follow-up histologic findings in a cohort of these women. Materials and Methods: All women undergoing co-testing at our institution (9/2007 to 12/2014) were retrospectively identified. hrHPV testing was performed with Hybrid Capture 2 (Digene Corporation, Gaithersburg, Maryland) (2007-2013) or Cobas 4800 (Roche Molecular Systems, Pleasanton, California) (after 1/2014). Original Pap tests from women with an HSIL/hrHPV negative co-test result and subsequent histology were blindly reviewed by two pathologists, and by a third pathologist in situations of disagreement. p16INK4a immunohistochemistry was performed on tissue from each patient, unless available from archived slides. Results: Of 220 women with HSIL cytology and co-testing, 28 (12.7%) were hrHPV negative. Cervical tissue from twenty women was available for review (Table 1). The average time to colposcopy follow-up was 38 days (range: 0-181 days). HSIL [CIN 2/3] was identified in nine women (45%). All were confirmed by positive p16INK4a staining. A low-grade squamous intraepithelial lesion (LSIL) was identified in four (20%), and benign findings were identified in seven (35%) women. All were p16INK4a negative. Nineteen original ThinPrepÒ slides were available for review. Six of the original Pap test interpretations were downgraded to atypical squamous cells, cannot rule out HSIL (ASCH) or ASC-H+LSIL. HSIL histology was identified in two women with downgraded cytology, and benign histology was found in the other four women. Conclusion: Nearly half of the women in this study with HSIL/hrHPV negative cytology had HSIL (CIN2-3) on follow-up. The remainder had low-grade lesions or no evidence of dysplasia. More conservative clinical management may be indicated in this subset of women if subsequent colposcopy and biopsy results are negative.

Abstracts

Table 1

Adjudicated Cytologic and Histologic Findings

54 Efficacy of HPV Testing in Predicting CIN2+ in Women with an Unsatisfactory Pap Cytology Result Daniel Davis, DO, Abha Khanna, MA, CT(ASCP), Marilyn Dawlett, CT(ASCP), Ming Guo, MD The University of Texas MD Anderson Cancer Center, Houston, Texas Introduction: Unsatisfactory Pap testing results are frequently seen in patients in our cancer center, attributed to older-aged patient or therapy effects. To evaluate whether HPV testing in the Pap specimen can help predict high-grade cervical intraepithelial neoplasms (CIN2 or 3) in these patients, we reviewed the follow-up data from patients with both unsatisfactory Pap testing results and HPV testing results. Materials and Methods: We retrospectively searched the pathology database at our institution for the period from 2006 to 2013. Of 50,598 Pap (SurePath) testing results, 933 (1.8%) were classified as unsatisfactory. HPV testing was performed on 222 of these Pap specimens. Of these, follow-up data were available for 138 women (261 Pap cytology tests and 27 biopsies) with a median time of 13 months. The HPV testing was performed by using either the HC2 (114 cases) or Cervista HPV HR (24 cases) assay. Results: Nine cases tested with Cervista HPV had insufficient DNA and were excluded from the data analysis. Data from a total of 138 patients qualified for analysis. Patient age ranged from 22 to 87 years (mean, 56 years; median, 57 years). Six of the 138 (4%) HPV test results were positive. Of these, one patient had high-grade squamous intraepithelial lesion (HSIL) on follow-up Pap cytology. Of 132 patients with a negative HPV testing result, one had a CIN2 result on follow-up biopsy. The risk for HSIL/CIN2+ for patients with an unsatisfactory Pap specimen and a positive HPV testing result (17%) was significantly higher than the risk for patients with an unsatisfactory Pap specimen and a negative HPV testing result (0.8%), with an odds ratio of 26.2 (Table 1). Conclusions: HPV testing in Pap cytology specimens with an unsatisfactory Pap result is useful in predicting HSIL/CIN2+, supporting the clinical use of HPV testing in these Pap specimens.