Sana O. Tabbara MD1* and Ritu Nayar MD2*#^
*American Society of Cytopathology Representatives
# Cytopathology Education and Technology Consortium Representative
^ Pathologist on ASCCP Guidelines Steering Committee
- The George Washington University, Department of Pathology, Washington, District of Columbia
- Northwestern University, Feinberg School of Medicine, Department of Pathology and Northwestern Memorial Hospital, Chicago, Illinois
The 2019 ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening tests and Cancer Precursors were published on April 2, 2020 in the Journal of Lower Genital Tract Diseases.1 Following a Memorandum of Understanding between the ASCCP and National Cancer Institute (NCI) in January 2017, seven (7) working groups with representation from stakeholders across medical professional societies, patient advocacy groups and federal agencies were tasked with updating the guidelines following a kickoff meeting in February 2018. The focus was organized around the goal of establishing consensus Clinical Action Thresholds rather than specific test outcomes using analysis and follow-up from large data groups. The analysis relied on the comprehensive data set from Kaiser Permanente Northern California and other large population groups to address applicability of the recommendations to a diverse patient population in the United States. A total of eleven (11) pathologists representing the CETC, ASC, CAP, ASCP and Papanicolaou Society participated in all working groups, and two (2) Pathologists were members of the steering committee. A working conference was held in June 2019 and the final Consensus Conference was held in October 2019 following a period for public comments. In follow up, the pathologist representatives from the pathology professional societies provided a synopsis of implications of the 2019 guidelines and suggestions for pathology laboratories.2
With the guiding principle of “equal management for equal risk,” the primary change in the new guidelines is the approach to determining risk, while the goal of screening remains to detect and manage abnormal findings and aim at the detection and treatment of precancers (high grade squamous intraepithelial lesion [HSIL]/cervical intraepithelial neoplasia [CIN3]). In a drive to personalize patient management, the focus is to move away from assessing risk imparted by a diagnosis obtained from testing at a single point in time to incorporating additional risk factors created by patient age and patient history, including the lack of a screening history. Furthermore, the 2019 guidelines rely on high risk Human Papilloma Virus (hrHPV) based testing that includes both primary testing and cotesting as an essential component for determining and managing patients with abnormal results. The guidelines link all testing modalities from primary hrHPV, to cotesting, to cytology alone with Clinical Action Thresholds. Emphasis is placed on the importance of using hrHPV assays per the regulatory Food and Drug Administration (FDA) approval in the United States, as it pertains to primary testing, surveillance, and cotesting. While cytology alone is still an acceptable tool for testing when hrHPV is not available, it is less sensitive and primary HPV testing and cotesting are preferred for surveillance.
Patient risk level is calculated and tied to clinical actions that vary from routine screening to surveillance to treatment. In order to avoid overtreatment, it is only when the combination of test results and individual screening history (including the absence of screening history) yields a four percent (4.0%) or greater probability of finding CIN3+ that the patient is referred to colposcopy. Risk calculation can be achieved by using a mobile phone App or a free web-based risk calculator available on the ASCCP website, as well as by referring to the tables published in Engemen et al.3
The approach to managing test results has evolved as well. Surveillance/observation without colposcopy is the recommended approach for minor screening abnormalities preceded by a negative history (primary HPV or cotesting) and associated with an immediate low risk for HSIL/CIN3+. That approach is also preferred in patients with an initial result of low grade squamous intraepithelial lesion (LSIL/CIN1) that follows a previous negative HPV based test. On the other hand, and in practicing shared-decision making with the patient to weigh risks and benefits, expedited treatment based on cytology and HPV based testing, without an intervening biopsy, is now preferred in patients twenty five (25) years or older when the immediate risk of CIN3+ is equal or higher than sixty percent (60%). Expedited treatment is also a preferred approach for nonpregnant patients with HSIL cytology and concurrent positive testing for HPV genotype 16 (HPV 16) and in patients with HSIL with never or rare screening history irrespective of genotype and is also acceptable if the risk of CIN3+ is twenty-five to sixty percent (25-60%). Management of glandular abnormalities and adenocarcinoma in situ (AIS) have not seen a significant change and excision remains the treatment of choice in AIS, meaning that triage by hrHPV is not acceptable. The guidelines also emphasize the necessity of genotyping (HPV 16/18) and reflex cytology from the same test vial when primary HPV test results are positive, as these genotypes are significantly associated with CIN3+ and increased risk for invasive carcinoma, and as cytologic findings will help determine management and colposcopy practice. Finally, the need for repeat testing when cytology results are unsatisfactory and the importance of not using a negative HPV result in that setting to triage patient for further management is underscored in the guidelines.
Moreover, changes were made to long term surveillance following treatment and management of histologic HSIL, CIN2, CIN3, or AIS based on the associated risk of developing cancer. For example, the 2019 guidelines recommend surveillance at a 3-year interval for at least twenty-five (25) years and as long patient health condition and life expectancy permits. A modified approach for special populations including patients younger than twenty-five (25) years of age, pregnant and immunosuppressed patients, patients over age 65 and post-hysterectomy patients is clearly outlined.
In addition, the guidelines support the use of Lower Anogenital Squamous Terminology (LAST)/World Health Organization (WHO) recommendations for reporting histologic diagnoses and qualifying HSIL to include CIN2 or CIN3 with judicious use of p16 immunostaining, as these qualifiers entail more specific management decisions.
Finally, the 2019 ASCCP Risk-Based Management Consensus Guidelines are designed in a way to allow for flexible and continuous updates as new testing modalities are incorporated and as the vaccinated population reaches screening age. Once adopted, they will establish the goal of reducing overtreatment while addressing high risk patients with uncompromising treatment and surveillance, resulting in optimal cancer prevention.
- Perkins RB, Guido RS, Castle PE, et al. 2019 ASCCP Risk-Based Management Consensus Guidelines for abnormal cervical cancer screening tests and cancer precursors. J Low Genit Tract Dis 2020; 24: 102–131.
- Nayar R, Chhieng DC, Crothers B, Darragh TM, Davey DD, Eisenhut C, Goulart R, Huang EC, Tabbara SO. Moving Forward — The 2019 ASCCP Management Guidelines and Beyond: Implications and Suggestions for Laboratories. JASC 2020. https://doi.org/10.1016/j.jasc.2020.05.002
- Egemen D, Cheung LC, Chen X, et al. Risk estimates supporting the 2019 ASCCP Risk-Based Management Consensus Guidelines. J Low Genit Tract Dis 2020; 24:132–143.