Risk Estimates Supporting the 2019 ASCCP Risk-Based Management Consensus Guidelines

Abstract

Objective The 2019 American Society for Colposcopy and Cervical Pathology Risk-Based Management Consensus Guidelines for the management of cervical cancer screening abnormalities recommend 1 of 6 clinical actions (treatment, optional treatment or colposcopy/biopsy, colposcopy/biopsy, 1-year surveillance, 3-year surveillance, 5-year return to regular screening) based on the risk of cervical intraepithelial neoplasia grade 3, adenocarcinoma in situ, or cancer (CIN 3+) for the many different combinations of current and recent past screening results. This article supports the main guidelines presentation 1 by presenting and explaining the risk estimates that supported the guidelines. Methods From 2003 to 2017 at Kaiser Permanente Northern California (KPNC), 1.5 million individuals aged 25 to 65 years were screened with human papillomavirus (HPV) and cytology cotesting scheduled every 3 years. We estimated immediate and 5-year risks of CIN 3+ for combinations of current test results paired with history of screening test and colposcopy/biopsy results. Results Risk tables are presented for different clinical scenarios. Examples of important results are highlighted; for example, the risk posed by most current abnormalities is greatly reduced if the prior screening round was HPV-negative. The immediate and 5-year risks of CIN 3+ used to decide clinical management are shown. Conclusions The new risk-based guidelines present recommendations for the management of abnormal screening test and histology results; the key risk estimates supporting guidelines are presented in this article. Comprehensive risk estimates are freely available online at https://CervixCa.nlm.nih.gov/RiskTables.

Moving forward—the 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors and beyond: implications and suggestions for laboratories

“…Risks were estimated by NCI statisticians using large population data sets in the United States. 13 Kaiser Permanente Northern California is the largest, most comprehensive data set in the United States, although for the 2019 guidelines, additional databases were analyzed to ensure that results are applicable to patients of diverse racial, ethnic, and socioeconomic strata. Risk estimates were compared using screening and followup data from clinical trials (BD Onclarity registrational trials), the New Mexico State HPV Pap Registry, and the US Centers for Disease Control and Prevention's National Breast and Cervical Cancer Early Detection Program, a national program that includes many low-income and minority patients.…”

“…Management options include return to routine screening, a shortened surveillance interval (1 year or 3 years), colposcopy, or treatment. Providers can use the 2019 ASCCP guidelines to manage their patients by using the tables in Egemen et al 13 or by inputting patient results and history into either a new ASCCP mobile app or Web site designed to facilitate navigation of the tables available at http://www. asccp.org, including a no-cost version.…”

“…However, if the prior result was a negative HPV primary screen or cotest, the immediate CIN 3þ risk is 2% if, resulting in a 1-year HPV-based follow-up (Table 1A, Egemen D, et al). 13 If the ASC-US/HPVpositive was followed by colposcopy with biopsy showing CIN1 the prior year, the negative colposcopy reduces the risk of CIN 3þ within the next 2 years, and the immediate risk of CIN 3þ would be 3.1%, also resulting in a 1-year HPV-based follow-up (Table 4A, Egemen D, et al). 13 The New Technology Committee will continue to assess and implement updates as new tests become approved and available, providing an enduring platform for new developments to be incorporated and the ability for the 2019 ASCCP guidelines to be updated on a more regular basis, without a large consensus conference effort.…”

“…13 If the ASC-US/HPVpositive was followed by colposcopy with biopsy showing CIN1 the prior year, the negative colposcopy reduces the risk of CIN 3þ within the next 2 years, and the immediate risk of CIN 3þ would be 3.1%, also resulting in a 1-year HPV-based follow-up (Table 4A, Egemen D, et al). 13 The New Technology Committee will continue to assess and implement updates as new tests become approved and available, providing an enduring platform for new developments to be incorporated and the ability for the 2019 ASCCP guidelines to be updated on a more regular basis, without a large consensus conference effort. Additional risk modifiers, such as HPV vaccination status, will also be added, as vaccinated cohorts in the United States enter screening age, and enough data accumulates.…”

“…24 In the 2019 ASCCP risk-based management consensus guidelines, HPV-based testing is the basis for risk estimation and laboratories will likely see a larger volume of HPV testing requests. 13,14 The term HPV-based testing is used in the 2019 ASCCP guidelines to refer to use of either primary HPV testing alone or HPV testing in conjunction with cervical cytology (cotesting). 15 Previously, HPV testing had mostly been used for cotesting or as a reflex test for an ASC-US cytology.…”