Changes to the Clinical Management of Participants at Intermediate Risk

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NATIONAL CERVICAL SCREENING PROGRAM GUIDELINES

THE RENEWED NATIONAL CERVICAL SCREENING PROGRAM: Quick Reference Guide CHANGES TO THE CLINICAL MANAGEMENT OF PARTICIPANTS AT INTERMEDIATE RISK

HOW HAS THE INTERMEDIATE RISK PATHWAY CHANGED Under the renewed NCSP Clinical Guidelines published in 2016, screening participants who have had an intermediate risk cervical screening result (HPV not-16/18 positive with reflex LBC prediction negative, pLSIL or LSIL) were recommended to have a follow-up HPV test at 12 months and be managed as higher risk and referred to colposcopy if any HPV is detected in their follow-up test. In light of new evidence, it is now recommended that participants with a 12-month follow-up HPV test result of HPV (not-16/18) detected, with LBC prediction of negative, pLSIL or LSIL be regarded as still at intermediate risk and undertake a second HPV follow-up test in a further 12 months’ time. If any HPV is detected at the 2nd follow up HPV test these participants should be referred to colposcopy. This recommendation came into effect on 1st February 2021.

www.vcs.org.au/pathology

WHY THIS CHANGE HAS OCCURRED In April 2020, an expert committee reviewed program data relating to biopsy outcomes in participants referred to colposcopy following persistent detection of oncogenic HPV (not 16/18) at their 12-month follow-up HPV test, where LBC was either negative, pLSIL or LSIL. This review found that the risk of CIN2/3 or cervical cancer among this cohort is very low. These data provide reassurance that if HPV (not 16/18) is detected at 12 months with reflex LBC prediction negative, pLSIL or LSIL, patients can safely be retested with an HPV test in a further 12 months. If HPV infection persists at that time these patients should be referred to colposcopy. This change will avoid many unnecessary colposcopies and associated harms (including biopsy, overtreatment, anxiety and financial costs) for screening participants with HPV-related cervical abnormalities that would resolve spontaneously without medical intervention. It will also enable colposcopy clinics to better manage demand and ensure timely access for participants who are at high risk.

Copyright Notice © 2021 VCS Foundation Limited (ACN 609 597 408) These materials are subject to copyright and are protected by the Copyright Laws of Australia. All rights are reserved. Any copying or distribution of these materials without the written permission of the copyright owner is not authorised.

EXCLUSIONS TO THE NEW RECOMMENDATIONS The following groups may be at elevated risk of harbouring a high-grade abnormality and should be referred to colposcopy if HPV is detected at 12 months, regardless of the result of reflex cytology. These include: • participants two or more years overdue for screening at the time of the initial screen • participants who identify as Aboriginal or Torres Strait Islander • participants aged 50–69 years If your patient is in one of the above elevated risk groups, but has already been waiting more than 9 months for a colposcopy under the previous NCSP Clinical Guideline recommendations, a follow-up test should be considered in the first instance. Referral to colposcopy continues to be recommended for all participants with self-collected samples at intermediate risk who test positive for HPV (any type) at 12 months after an initial positive test.

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NATIONAL CERVICAL SCREENING PROGRAM GUIDELINES

CHANGES TO THE CLINICAL MANAGEMENT OF PARTICIPANTS AT INTERMEDIATE RISK LEGEND Primary test

HPV detected (not 16/18)

INTERMEDIATE RISK PATHWAY

EXCLUSIONS TO THE NEW RECOMMENDATIONS (CONT)

Test result Recommendation

Woman’s risk of developing cervical cancer precursors LEGEND Primary test

Negative

Low

pLSIL/LSIL

Intermediate

Test result

• immune deficient participants

Higher

Recommendation

Woman’s risk of developing cervical cancer precursors

DES: diethylstilboestrol LSIL: low-grade squamous intraepithelial lesion HSIL: high-grade squamous intraepithelial lesion pLSIL: possible low-grade squamous intraepithelial lesion pHSIL: possible high-grade squamous intraepithelial lesion

Repeat HPV test in 12 months

Low

L

Intermediate Higher

*Includes pHSIL, HSIL, cancer or glandular abnormality.

HPV detected (not 16/18)

DES: diethylstilboestrol LSIL: low-grade squamous intraepithelial lesion HSIL: high-grade squamous intraepithelial lesion pLSIL: possible low-grade squamous intraepithelial lesion pHSIL: possible high-grade squamous intraepithelial lesion

• participants currently undergoing Test of Cure following treatment of histological HSIL • participants currently undergoing annual co-test following treatment of adenocarcinoma in-situ • participants being screened under the self-collection pathway

LBC negative/pLSIL/ LSIL

Repeat HPV test in 12 months

HPV not detected

Cancer Council Australia Cervical Cancer Screening Working Party. Clinical pathway: Cervical screening pathway. National Cervical Screening Program: Guidelines for the management of screen detected abnormalities, screening in specific populations and investigation of abnormal vaginal bleeding. CCA 2016. Accessible from http://wiki.cancer.org.au/australia/Guidelines:Cervical_cancer/ Screening. Updated Dec 2020. Refer for

• participants exposed to DES in utero

• participants aged 70+ (attending for an exit test)

*Includes pHSIL, HSIL, cancer or glandular abnormality.

ect referral to coloscopy ecommended for: omen 50+ years boriginal and/or Torres rait Islander women omen overdue for reening by at least 2 years

Note that there are other groups of participants who fall outside these recommendations as there are separate guidelines specifically for them, including:

Routine 5-yearly screening

FOR FURTHER INFORMATION Direct referral to coloscopy is recommended for: • women 50+ years • Aboriginal and/or Torres Strait Islander women • women overdue for screening by at least 2 years

HPV detected any

Refer for colposcopic assessment

The revised recommendations are outlined in Chapter 6 of the ‘NCSP Clinical Guidelines: National Cervical Screening Program: Guidelines for the Management of Screen Detected Abnormalities, Screening in Specific Populations and Investigation of Abnormal Vaginal Bleeding’ https://wiki.cancer.org.au/australia/Clinical_ question:Oncogenic_HPV_types_not_16/18 For queries about clinical guidelines and management of patients please contact the VCS Liaison Physician Team. Tel: (03) 9250 0309 or email: LiaisonTeam@vcs.org.au

colposcopic assessment

www.vcspathology.org.au

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