ORIGINAL RESEARCH ARTICLE:CERVIX AND HPV 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors Rebecca B. Perkins, MD, MSc,1 Richard S. Guido, MD,2 Philip E. Castle, PhD,3 David Chelmow, MD,4 Mark H. Einstein, MD, MS,5 Francisco Garcia, MD, MPH,6 Warner K. Huh, MD,7 Jane J. Kim, PhD, MSc,8 06/05/2020 on BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3wX04VDhDA6562ASvZQF6y+i/9vPBQOaKGvZHVBTglws= by https://journals.lww.com/jlgtd from Downloaded Anna-Barbara Moscicki, MD,9 Ritu Nayar, MD,10 Mona Saraiya, MD, MPH,11 George F.Sawaya, MD,12 Nicolas Wentzensen, MD, PhD, MS,13 and Mark Schiffman, MD, MPH14 for the 2019 Downloaded ASCCP Risk-Based Management Consensus Guidelines Committee from Key Words: cervical cytology, HPV testing, management of https://journals.lww.com/jlgtd abnormal cervical cancer screening tests, guidelines (J Low Genit Tract Dis 2020;24: 102–131) by BhDMf5ePHKav1zEoum1tQfN4a+kJLhEZgbsIHo4XMi0hCywCX1AWnYQp/IlQrHD3wX04VDhDA6562ASvZQF6y+i/9vPBQOaKGvZHVBTglws= Table of Contents SECTION E. PARADIGM SHIFT: E.1 Clinical Action Thresholds A. EXECUTIVE SUMMARY CLINICAL ACTION Leading to Recommendation B. INTRODUCTION THRESHOLDS of Surveillance E.2 Clinical Action Threshold C. GUIDING PRINCIPLES Leading to Recommendation D. METHODS SUB-SECTION of Colposcopy D.1 Process and Timeline E.3 Clinical Action Thresholds D.2 Choice of CIN3+ as Main Leading to Recommendations Clinical Endpoint for of Treatment Risk Estimates E.4 Clinical Situations Leading to D.3 Multiple Data Sets Used to Management Recommendation Validate Risks F. UPDATES RELATED F.1 Statement on the Use of a 2-Tier D.4 Estimation of Risks TO PATHOLOGY Terminology (Histologic D.5 Assigning Combinations of Test REPORTING AND LSIL/HSIL) for Reporting Results to Clinical Actions LABORATORY TESTS Histopathology of Squamous D.6 Rating the Recommendations Lesions of the Lower Anogenital Tract F.2 Updated Management of Primary HPV Screening (Replaces Interim Guidance) F.3 Statement on HPV Tests Used in Management From the 1Boston University School of Medicine/Boston Medical Center, Boston, MA; 2University of Pittsburgh/Magee-Women's Hospital, Pittsburgh, PA; 3Albert Einstein College of Medicine, New York, NY; 4Virginia Common- wealth University School of Medicine, Richmond, VA; 5Rutgers, New Jersey (Qiagen, Roche, BD, MobileODT, Arbor Vita) for independent evaluations Medical School, Newark, NJ; 6Pima County Health & Community Services, of screening methods and strategies. A.-B.M. is an advisory board member 7 8 on Tucson, AZ; UAB School of Medicine, Birmingham, AL; Harvard T.H. Chan of Merck and GSK. R.S.G. is an ASCCP consultant of Inovio 06/05/2020 School of Public Health Boston, MA; 9University of California, Los Angeles, Pharmaceuticals DSMB. W.K.H. is connected with Inovio Pharmaceuticals CA; 10Northwestern University, Feinberg School of Medicine-Northwestern Memo- DSMB. P.E.C. has received HPV tests and assays at a reduced or no cost rial Hospital, Chicago, IL; 11Division of Cancer Prevention and Control, Cen- from Roche, Becton Dickinson, Arbor Vita Corporation, and Cepheid for ters for Disease Control and Prevention, Atlanta, GA; 12University of research. M.H.E. has advised companies and participated in educational California, San Francisco, San Francisco, CA; 13Division of Cancer Epidemiol- activities but does not receive any honoraria or payments for these activities, ogy and Genetics and Division of Cancer Prevention, National Cancer Institute, In some cases, his employer, Rutgers, receives payment for his time for Bethesda, MD; and 14Division of Cancer Epidemiology and Genetics and Divi- these activities from Papivax, Cynvec, Merck, Hologic, and PDS sion of Cancer Prevention, National Cancer Institute, Bethesda, MD Biotechnologies. He has been the overall PI or local PI for clinical trials This article is open access, and reprints are available for download at asccp.org, from Johnson&Johnson, Pfizer, Iovance, and Inovio. Funding for these jlgtd.com, or via pubmed. activities is for the research related costs of the trials. The other authors have R.B.P. and R. S. G. contributed equally to the development of this manuscript declared they have no conflicts of interest. and are co-first authors. Disclaimer: The conclusions, findings, and opinions expressed by authors The guidelines effort received support from the National Cancer Institute and contributing to this journal do not necessarily reflect the official position of the ASCCP. Participating organizations supported travel for their participating US Department of Health and Human Services, the Public Health Service, the representatives. All participating consensus organizations, including the Centers for Disease Control and Prevention, or the National Cancer Institute. primary funders, had equal and balanced roles in the consensus process Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on including data analysis and interpretation, writing of manuscript, and behalf of the ASCCP. This is an open-access article distributed under the decision to submit for publication. No industry funds were used in the terms of the Creative Commons Attribution-Non Commercial-No Derivatives development of these guidelines. The corresponding authors had final License 4.0 (CCBY-NC-ND), where it is permissible to download and share responsibility for the submission decision. the work provided it is properly cited. The work cannot be changed in any The National Cancer Institute (including M.S. and N.W.) receives cervical way or used commercially without permission from the journal. screening results at reduced or no cost from commercial research partners DOI: 10.1097/LGT.0000000000000525 102 Journal of Lower Genital Tract Disease • Volume 24, Number 2, April 2020 Journal of Lower Genital Tract Disease • Volume 24, Number 2, April 2020 2019 Consensus Guidelines A. EXECUTIVE SUMMARY G. RARE CYTOLOGY G.1 Evaluation of cytology RESULTS interpreted as atypical glandular Updated US consensus guidelines for management of cervical cells (AGC) or adenocarcinoma screening abnormalities are needed to accommodate the 3 available in situ (AIS) cervical screening strategies: primary human papillomavirus (HPV) G.2 Unsatisfactory Cytology screening, cotesting with HPV testing and cervical cytology, and cer- G.3 Absent Transformation vical cytology alone. New data indicate that a patient's risk of devel- Zone on Cytology oping cervical precancer or cancer can be estimated using current G.4 Benign Endometrial Cells in screening test results and previous screening test and biopsy results, Premenopausal Patients or while considering personal factors such as age and immunosuppres- Benign Glandular Cells in sion. Routine screening applies only to asymptomatic individuals Post-Hysterectomy Patient who do not require surveillance for prior abnormal screening results. H. COLPOSCOPY H.1 ASCCP Colposcopy Standards The 2012 consensus guidelines were the first to be based on PRACTICE STANDARDS H.2 Exceptions to AND EXCEPTIONS TO Colposcopy Threshold the principle of equal management for equal risk, specifically, the COLPOSCOPY CLINICAL risk of a patient developing cervical cancer, estimated by the surro- ACTION THRESHOLD gate end point of the 5-year risk of cervical intraepithelial neoplasia I. MANAGING HISTOLOGY I.1 Histologic HSIL, Not Further (CIN) grade 3 (CIN 3) or more severe diagnoses (CIN 3+), regard- RESULTS Specified or Qualified less of which test combinations yielded this risk level. Introduction I.2 Management of Histologic of risk-based guidelines in 2012 was a conceptual breakthrough, HSIL (CIN 2 or CIN 3) but the recommendations retained a continued reliance on compli- I.3 Management of CIN 2 in Those cated algorithms and insufficiently incorporated screening history. Who Are Concerned About the With a more nuanced understanding of how previous results affect Potential Effect of Treatment on risk, and more variables to consider, the 2019 guidelines further Future Pregnancy Outcomes align management recommendations with current understanding I.4 Management of Histologic LSIL (CIN 1) or less of HPV natural history and cervical carcinogenesis. More frequent Preceded by ASC-H or surveillance, colposcopy, and treatment are recommended for pa- HSIL Cytology tients at progressively higher risk, whereas those at lower risk can I.5 Histologic LSIL (CIN 1) defer colposcopy, undergo follow-up at longer surveillance inter- Diagnosed Repeatedly for at vals, and, when at sufficiently low risk, return to routine screening. Least 2 Years. Clearly defined risk thresholds to guide management are designed I.6 Management of AIS: Adoption of to continue functioning appropriately when population-level preva- Society of Gynecologic Oncology lence of CIN 3+ decreases because of HPV vaccination and also as Recommendations new screening and triage tests are introduced. The revised guidelines J. SURVEILLANCE AFTER J.1 Specific Tests and Testing provide a framework for incorporating new data and technologies as ABNORMALITIES Intervals When Managing ongoing incremental recommendation revisions, minimizing the time Abnormal Results J.2 Short-Term Follow-up After needed to implement changes that are beneficial to patient care. Treatment for Histologic HSIL J.3 Guidance for Long-Term B. INTRODUCTION Follow-up After Treatment for High-Grade Histology This is the fourth American Society of Colposcopy and Cer- or Cytology vical Pathology (ASCCP)-sponsored consensus