Review of the Guidelines for Cervical Screening in New Zealand

Review of the Guidelines for Cervical Screening in New Zealand Presentation for colposcopists September 2008 Presentation overview • The review process • Guidelines overview and key changes • HPV testing • Further information The new guidelines • Title: “Guidelines for Cervical Screening in New Zealand” • Update 1999 guidelines • Provide recommendations on management of women participating in cervical screening - assessment, treatment and follow-up - are guidelines ie, they do not override clinical decisions, particularly if women have clinical symptoms The review process • Two multidisciplinary expert working groups • Extensive review of literature and guidelines of other countries • NSU commissioned cost-effectiveness evaluation:  Guidelines (without HPV testing) – cost-effective but neutral in cancer impact  HPV testing for triage of women over 30 yrs – would reduce cervical cancer cases  100% LBC plus HPV triage – cost-effective  HPV testing post-treatment – found to be cost effective and lead to long term savings. The 5 main sections • Management of women with normal cervical smears • • Management of women with unsatisfactory cervical smears Management of women with abnormal cervical smears • • Management of women in special clinical circumstances HPV testing guidance Guidelines overview and key changes The most significant changes • Changes to follow-up time for women with low grade smear abnormalities • Additional information on various clinical circumstances • The introduction of HPV testing (from 1 July 2009) Age range and screening interval • • Age range and screening interval unchanged – for review by NSU within 3-5 years Women under 20 years must not be routinely screened - can cause more harm than benefit • Note WHO (2006) recommendation (new programmes):  no screening women <25 yrs  3 year interval for women 25-49 yrs  5 year interval for women >50 yrs. Management of women with normal cervical smears • Recall in 3 years – not before SHORT INTERVAL RE-SCREENING - Represents unnecessary use of NCSP resources - Impacts on laboratory turn around times - Can lead to inappropriate treatment Management of women with unsatisfactory smears • Repeat the smear within 3 months • There may be situations where LBC offers some advantage over conventional smears, such as women with: – excessive cervical mucus, discharge or blood – recurrent inflammatory smears – recurrent unsatisfactory smears Liquid Based Cytology Policy (2006) Management of women with abnormal cervical smears Low- grade: ASC-US or LSIL smear report CERVICAL SMEAR REPORT GUIDELINE Women aged 20 - 29 years with no abnormal smear reports within the last 5 years Repeat cervical smear in 12 months Until 1 July 2009: Women aged 30 years and over with one (or more) normal smear reports in the last 5 years Repeat cervical smear in 12 months Women aged 30 years and over who haven't had a smear in the last 5 years should be offered either a repeat smear within 6 months or a referral to colposcopy. HrHPV testing as from 1 July 2009 ASC-US or LSIL ie: - extends time for repeat smear from 6 to12 months - HrHPV testing from 1 July 2009 Management of women with low-grade abnormalities: ASC-US or LSIL Low-grade: flowchart Cervical smear report ASC-US / LSIL Women 20 - 29 years Women 30 years and over Previous abnormal report within last 5 years No abnormal report within last 5 years Previous abnormal report within last 5 years 1 or more normal reports within the last 5 years No smear within the last 5 years Colposcopy Repeat smear in 12 months Colposcopy Repeat smear in 12 months Either Repeat smear in 6 months OR Colposcopy As from 1 July 2009 triage with HPV testing as per NCSP Best Practice Guidance on HPV Testing Low-grade: colp. assessment COLPOSCOPIC ASSESSMENT GUIDELINE Satisfactory and normal Refer back to the smear taker for two annual smears. 1. If either smear is abnormal, refer for repeat colposcopy. 2. If both smears are negative, resume routine screening. Note: recall 12 months rather than 6 months Unsatisfactory Cytology review is recommended. • If low-grade cytology is confirmed on review, repeat colposcopy and cytology in 12 months. • Management may be individualised…. Colposcopic assessment of ASC-US / LSIL Low-grade: colposcopy and management of confirmed histology assessment Colposcopic Assessment Satisfactory & normal Satisfactory & abnormal Unsatisfactory Target biopsy Cytology review recommended CIN1 CIN2 / 3 LSIL confirmed Refer back to smear taker Treatment see special circumstances for pregnancy and under 20 yrs Repeat colposcopy and cytology in 12 months Repeat smear at 12 months Any abnormal smears Repeat smear at 12 months  Management may be individualised based on age, reproductive status and clinical risk.  Treatment is not usually indicated. Routine 3-yearly screening Low-grade: histology confirmed HISTOLOGY REPORT GUIDELINE Treatment is not recommended, as such lesions are considered to be an expression of a productive HPV infection. Histologically confirmed low grade squamous abnormalities Refer back to smear taker for repeat cytology at 12 and 24 months. If both smears are negative, it is recommended that the woman return to routine screening. If either repeat smear shows ASC-US / LSIL or higher ie: HSIL / ASC-H / AGC /AIS then the woman should be referred back to colposcopy. Note: recall at 12 months rather than 6 months High-grade: ASC-H/HSIL CERVICAL SMEAR REPORT GUIDELINE Refer for colposcopy Refer for colposcopy and targeted biopsy where indicated. Urgent referral to a colposcopist or oncologist ASC-H HSIL HSIL with suspected invasion More information on colposcopic assessment of ASC-H/HSIL and on various treatment methods High-grade: colp. assessment COLPOSCOPIC ASSESSMENT GUIDELINE Satisfactory and abnormal Satisfactory and normal colposcopy or negative biopsy Targeted biopsy should be performed for histological diagnosis. Where biospy confirms CIN 1, manage based on MDM. Cytology review is recommended If review confirms high-grade, repeat colposcopy and cytology within 3 months: 1. If colposcopy and cytology normal at 3 months repeat cytology in 12 months. 2. If colposcopy or cytology LSIL at 3 months, individualise management based on multidisciplinary team review. 3. If colposcopy or cytology HSIL at 3 months, treatment is indicated. HrHPV testing to assist management as from 1 July 2009 Unsatisfactory colposcopy Cytology review is recommended If review confirms ASC-H / HSIL, cone biopsy is recommended. If review confirms normal or ASC-US or LSIL, manage based on MDM. High-grade: ASC-H /HSIL colposcopy Flowchart 3 Management of women with high-grade abnormalities: ASC-H or HSIL ASC-H / HSIL Colposcopic assessment Unsatisfactory Satisfactory Cytology review Normal (negative biopsy) ASC-US / LSIL Confirmed ASC-H / HSIL Abnormal Negative Cyto-histo review Target biopsy Management based on multidisciplinary team review Cone biopsy CIN1 CIN2/3 Negative ASC-US / LSIL ASC-H / HSIL Treatment See special circumstances for pregnancy and under 20 years Management based on multidisciplinary team review Repeat colposcopy in 3 months. (see summary table) Management based on multidisciplinary team review As from 1 July 2009 HPV testing may be used in some of the above situations to aid further management High-grade: confirmed CIN 2/3 Additional guidance on use of: • Ablative therapy • Cryotherapy • LEEP, LLETZ • Cold knife cone biopsy • Hysterectomy • See and treat • Treatment of women who plan to have children High-grade: post-treatment FOLLOW UP Routine follow up GUIDELINE A woman treated for CIN 2 or 3 should have a colposcopy and smear in 6-12 months. A cervical smear should be taken 12 months after treatment and annually thereafter until the age of 70. As from 1 July 2009, HrHPV testing …. High-grade: glandular AGC/AIS/AC - cytology • Proportionally, cervical adenocarcinomas are increasing. • Glandular lesions carry a significant risk of cancer. • Colposcopic assessment is mandatory for cytology suggesting glandular abnormalities. • CERVICAL SMEAR REPORT AGC or AIS or adenocarcinoma GUIDELINE Refer to a colposcopist or to an oncologist. High-grade: glandular colposcopy Flowchart 4 Colposcopic assessment and treatment of women with glandular abnormalities Glandular Abnormalities Atypical glandular cells (AGC) (AG1-5) Adenocarcinoma in situ (AIS) Adenocarcinoma (AC 1-4) Colposcopy Satisfactory & normal Satisfactory & abnormal Unsatisfactory Cytology review Consistent with cancer Favouring a neoplastic process (AIS) Cytology review Cytology confirmed Not confirmed Punch biopsy and refer to gynaecological oncologist Cone biopsy and D&C Confirmed favouring a neoplastic process Not confirmed Cone biopsy and D&C Multidisciplinary team review Cone biopsy and D&C Multidisciplinary team review As from 1 July 2009 HPV testing should be considered as a useful adjunct to management, As from 1 July 2009per NCSP Best Practiceconsidered on HPV Testing as HPV testing should be Guidance as a useful adjunct to management, as per NCSP Best Practice Guidance on HPV Testing Special clinical circumstances For example: SPECIAL CIRCUMSTANCE GUIDELINE Pregnancy Cervical smears and colposcopy are not contraindicated, however, it is not necessary to do routine cervical smears. Low-grade cytology lesions - a repeat smear after 12 months. High-grade lesions should be referred for colposcopic evaluation. Immunosuppressed women Refer abnormal smear results for colposcopy, even for a low-grade lesion. Summary: indications for case review • HSIL in women under 20 years • Discordance between cytology and colposcopy: - HSIL and normal colp. assessment - Abnormal glandular cytology and normal colp. assessment - Persistent LSIL and normal colp. assessment. • Unsatisfactory colposcopy and suggested highgrade disease. High risk HPV (HrHPV) testing HrHPV testing • Tests for 13 high risk HPV genotypes • Very high negative predictive value (approx 99%) • A positive HPV test indicates increased risk of developing a high grade lesion but does not indicate the presence of abnormal cell changes. • HPV testing is a useful adjunct to management. • Can be requested with LBC or as a separate swab. HrHPV testing and the NCSP • Operational from 1 July 2009. • “NCSP Best Practice Guidance on HPV Testing” is available at www.nsu.govt.nz • Of benefit in 3 main areas of management. 1. HPV testing for triage of low-grade smears Triage with HPV testing • For: – Women 30 years and over – No abnormal smear reports in the last 5 years – Low-grade smear result (ASCUS/LSIL) • Use of „reflex testing‟ – LBC or co-collection • Women who test positive for HrHPV will be referred to colposcopy. Women who are HrHPV negative return to 3 yearly recall (following another negative smear). Triage of women 30 years and over with ASC-US or LSIL (who have not had an abnormal smear within the last 5 years) HPV triage ASC-US/LSIL Women > 30 years ASCUS / LSIL HrHPV reflex test HrHPV positive HrHPV negative Refer to colposcopy Repeat cytology at 12 months Cytology > ASC-US Cytology negative Refer to colposcopy Return to 3 yearly screening 2. HPV testing posttreatment HPV testing: post-treatment • Following treatment for pre-cancerous lesions • Substitutes for annual smears for life • 2 negative HPV and smear tests - return to normal screening • Will require close monitoring of long term safety Follow-up of women treated for high-grade lesions HPV testing: post-treatment Histologically confirmed and treated HSIL Colposcopy follow-up with cytology at 6-12 months Cytology and HrHPV test 12 months post-treatment and again at 24 months post-treatment 12 months result: HrHPV negative cytology ASC-US / LSIL HrHPV negative cytology negative on both testing occasions HrHPV positive or cytology > ASC-H at either event Repeat cytology and HrHPV testing 24 months post treatment Return to 3-yearly screening Refer to colposcopy   HrHPV negative, cytology negative, repeat cytology in 12 months HrHPV negative, cytology ASC-US/LSIL, consider referral to colposcopy or continue annual screening HrHPV negative, cytology > ASC-H, refer to colposcopy HrHPV postive, refer to colposcopy irrespective of cytology result   HPV testing post-treatment HPV Testing Guidance 2 - EXTENDED (extended) Follow-up of women treated for high-grade lesions Discharged from colposcopy Cytology and HrHPV test 12 months post-treatment HrHPV negative cytology negative HrHPV negative cytology positive HrHPV positive cytology negative HrHPV positive cytology positive ASCUS / LSIL > ASC-H Colposcopy Colposcopy Repeat cytology & HrHPV testing at a further 12 months Colposcopy  HrHPV negative, cytology negative, repeat cytology in 12 months Cytology and HrHPV test 24 months posttreatment  HrHPV negative, cytology ASCUS/LSIL, consider referral to colposcopy or continue annual screening  HrHPV negative, cytology > ASC-H, refer to colposcopy  HrHPV positive, any cytology result, refer to colposcopy HrHPV negative cytology negative HrHPV negative cytology positive HrHPV positive cytology negative HrHPV positive cytology positive Return to 3-yearly screening ASCUS / LSIL 12 months repeat cytology Annual screening > ASC-H Colposcopy Colposcopy Colposcopy HPV testing: discordant results • ‘Discordant’ results eg; a high-grade smear result but colposcopy appears normal • HPV testing assists in management • Similar to „test of cure‟ flowchart Information and training • Women • Smear takers • Laboratory staff • Other health professionals Further information • www.nsu.govt.nz • Screening Matters Thank you.