Paps from Women >/= 30 with NILM and + HR HPV DNA, Focused Re-Screening, An Enhanced QC Measure

Transcription

1 Paps from Women >/= 30 with NILM and + HR HPV DNA, Focused Re-Screening, An Enhanced QC Measure Charles D. Sturgis, MD 1&2 Michael R. Schaaf, CT 1&3 Ronald J. Tickman, MD 1&3 1. CellNetix Pathology and Laboratories, WA 2. Providence Regional Med Center, Everett WA 3. Swedish Med Center, Seattle WA

2 Eastern Slopes of Mount Baker, Washington Photo taken from Artists Point, Fall 2010 (JE Porter, Jr.) Beautiful glaciers in the lower 48, (10,781 ft / 3286 m). 2

3 CONFLICTS OF INTEREST The authors of this work have no financial relationship with the manufacturers of any of the products discussed. No potential conflicts of interest are present. The data are derived from CellNetix Laboratories, and the results and conclusions are those of the authors. 3

4 What is CellNetix? Is it a high fiber breakfast cereal? No Is it trademark chemotherapeutic agent? No It s a group of pathology professionals in Washington State. (A PLLC and an LLC with a consolidated laboratory) CellNetix was founded in 2005 through the fusion of three practices: Seattle (Swedish), Everett (Providence), and Olympia (Providence). Now also Edmonds (Swedish Edmonds), Aberdeen (Grays Harbor), North Seattle (Northwest), Centralia (Providence). 44 pathologists with subspecialties in most areas of anatomic pathology. 4

5 Dr. Boudousquie Swedish Edmonds Dr. Fidda Providence Olympia Dr. Knierim Seattle Swedish Dr. McDonagh Seattle Swedish Dr. Patton Northwest Seattle Dr. Perez-Reyes Seattle Swedish Dr. Sturgis Providence Everett Dr. Tickman Seattle Swedish CellNetix Board Certified Cytopathologists 5

6 INTRODUCTION: -CLIA 88, 10% of NILM Paps QC re-screen. -ASCCP 2006, recommends HR HPV DNA testing as an adjunct to cytology in women >/= 30. -Guidelines create a population of women NILM / HRHPV +. -What would focused QC of this specific population show? 6

7 MATERIALS & METHODS: -386 consecutive NILM LB Paps with + HR HCII. (W >/= 30 yrs of age), (Four month period). (Represents 5.1% [386 /7170] of women >/= 30 for whom dual Pap and HR HPV ordered). -Mixture of ThinPrep and SurePath samples (Annual Pap volume 99,000), (20% TP & 80% SP), (Lab uses both TIS and Focal Point for all LB Pap cases). (13 cytotechnologist, 11.4 FTE). (Lab overall ASC/SIL ratio is 1.7). (Proportion of reflex ASC cases positive for HR HPV is 42%). -All 386 slides re-screened by cytotechnologists. -All re-screened slides judged as ASC or higher then reviewed by one or more cytopathologists (cds & rjt). -Final rescreen diagnosis set by one cytopathologist (cds). 7

8 RESULTS: -Of 386 NILM / HRHPV+ cases rescreened, 50 ASC or higher, and 11 SIL. Originally NILM Upgraded to ASC & Above Upgraded to ASC Upgraded to LSIL Upgraded to HSIL # % % of rescreened cases judged ASC or higher -2.8% of rescreened cases judged LSIL or higher -Routine QC comparison (including random, Focal Point enriched, and historical high risk): 20,580 / 99,501 cases rescreened (21%). 427 / 20,580 upgraded to ASC & above (2.1%). 52 / 20,580 upgraded to LSIL & above (0.25%). 8

9 RESULTS: Histolgoic Follow up Condyloma Example Of LSIL Upgrade 42 F No hx abnrml Paps. Most recent prior Pap, 2 yrs ago NILM & HCII neg. Current case with 2 of these cells. 9

10 RESULTS: Histolgoic Follow up CIN 2 to 3, Positive p16 Example Of HSIL Upgrade 49 F No hx abnrml Paps. First Pap in our lab. Current case with few of these single cells. 10

11 CONCLUSIONS: -Historical QC 2009 calendar year 2.1% ASC or higher. -Focused QC 4 month NILM/+HPV 13% ASC or higher. >6X more ASC and higher cases overlooked in the focused review population Historical QC 2009 calendar year 0.25% LSIL or higher. -Focused QC 4 month NILM/+HPV 2.8% LSIL or higher. >10X more SIL cases overlooked in the focused review population. 11

12 CONCLUSIONS: Five Year Experience of HPV DNA and Papanicolaou Test Cotesting March 2009 Obstetrics & Gynecology, 113(3): P.E. Castle, B. Fetterman, N. Poitras, T. Lorey, R. Shaber, W. Kinney (NIH & Kaiser of Oakland California). Objective: Methods: Results: Conclusion: To estimate the group specific HPV DNA positive fraction in a general screening population of women 30 and older. Kaiser Northern California, >500,000 women cotested (HC2). 3.99% of women >30 with NILM Pap were HPV positive. In a general screening population, concerns about excessive HPV test positives among women aged 30 years and older are not borne out. If apply %s from our rescreen study to this population of NILM / HRHPV+ women: 13% of this 4% (or 0.5%) of women would be upgraded to ASC or higher (0.5% of 1,000 = 5). 2.8% of this 4% (or 0.1%) of women would be upgraded to LSIL or higher (0.1% of 1,000 = 1). 12

13 CONCLUSIONS: High Risk HPV Testing in Women 30 Years or Older With Negative Papanicolaou Tests June 2010, Am J Clin Pathol, 133: M.J. Thrall, D.K. Russel, M.S. Facik, J. L. Yao, J.N. T.A. Bonfiglio, and E.J. Giampoli (Methodist Hospital, Houston & Univ of Rochester, New York). -To investigate the use of combined cytology and HR HPV DNA testing for screening in W >/=30. -2,686 women with NILM morphology, 5.4% HCII positive for HR HPV DNA -For both groups (NILM/HR HPV+ & NILM/HR HPV-) only half had follow up consistent with published recommendations. -More cytologic/histologic abnormalities found in HRHPV+ than patients, (P < ); however among women who underwent biopsy, no statistical difference in HPV+ vs HPV- groups. If apply %s from our rescreen study to this population of NILM / HRHPV+ women: 13% of this 5.4% (or 0.7%) of women would be upgraded to ASC or higher (0.7% of 1,000 = 7). 2.8% of this 5.4% (or 0.2%) of women would be upgraded to LSIL or higher (0.2% of 1,000 = 2). 13

14 CONCLUSIONS: Focused re-screening of slides from women 30 years of age and older who are found to be morphologically NILM but are also found to test positive for HR HPV DNA may enhance QC in cytopathology laboratories that perform liquid based Pap testing combined with adjuvant screening DNA testing. An inherent potential bias in study design is recognized, as results of DNA testing were by definition known at the time of re-screening. 14

15 Snoqualmie National Forest Consider a visit to one of the National Parks or Forests in Washington State. You will not regret the time. 15