Review of the Guidelines for Cervical Screening in New ... · Repeat cervical smear in 12 months....
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Review of the Guidelines for Cervical Screening in New Zealand Presentation for colposcopists September 2008
Transcript of Review of the Guidelines for Cervical Screening in New ... · Repeat cervical smear in 12 months....
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
• 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 new guidelines
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.
Presenter
Presentation Notes
The Guideline Development Team and the HPV Testing Working Group consisted of colposcopists, pathologists, virologists, epidemiologists, GPs, nurse smear takers consumer representatives and NSU members.
• 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
The 5 main sections
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.
Presenter
Presentation Notes
The Guidelines begin with the NCSP screening policy. The NCSP policy is not to start screening of under 20 year olds . 2007 data shows that over 3 years about 4-5000 smears were taken from women under 20 years each year. Sexually active women of this age have high rates of abnormal cytology caused by transient HPV infections but the risk of invasive cancer is extremely low. In New Zealand the rate of invasive cervical cancer in women under 20 years is less than .01 per 100,000 women (NCSP data for 2002- 2006). Studies that show small increased risk of future preterm delivery, low birth weight and premature rupture of membranes point to the need for caution in the treatment of women of reproductive age with mild cervical abnormalities. Screening women under 20 years diverts resources from women who could genuinely benefit from screening.
Management of women with normal cervical smears
• Recall in 3 years – not before
SHORT INTERVAL RESHORT INTERVAL RE--SCREENINGSCREENING
- Represents unnecessary use of NCSP resources
- Impacts on laboratory turn around times
- Can lead to inappropriate treatment
Presenter
Presentation Notes
The new guidelines emphasise the importance of avoiding early re-screening. A screening interval between 30-42 months is acceptable.
Management of women with unsatisfactory smears
•• Repeat the smear within 3 monthsRepeat 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
LiquidLiquid Based Cytology Policy (2006)Based Cytology Policy (2006)
Presenter
Presentation Notes
LBC tends to result in fewer unreadable slides. Evidence is mixed as to whether LBC is more accurate for detection of abnormalities. LBC has significant practical advantages eg, it allows automated slide reading and an HPV test can be done off the same sample. There are two main causes of unsatisfactory samples: - taking the smear – inadequate sampling of the cervix, poor fixation, contact bleeding due to over zealous smearing, unwanted artefacts eg, lubricating jelly - clinical factors – bleeding, inflammation, cytolysis. Smear takers who routinely use the Pap smear technique may elect to sample by LBC following an unsatisfactory result.
Management of women with abnormal cervical smears
Presenter
Presentation Notes
.
Low- grade: ASC-US or LSIL smear report
CERVICAL SMEAR REPORT
GUIDELINE
ASC-US or LSIL
Women aged 20 - 29 years with no abnormal smear reports within the last 5 yearsRepeat cervical smear in 12 monthsUntil 1 July 2009:Women aged 30 years and over with one (or more) normal smear reports in the last 5 yearsRepeat 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
ie: - extends time for repeat smear from 6 to12 months- HrHPV testing from 1 July 2009
Presenter
Presentation Notes
This is part of the summary table for low-grade smear results. The new guidelines extend the time for a repeat smear from 6 to 12 months. The key rationale for this is to allow time for HPV viral clearance, as evidence shows high rates of spontaneous regression for low-grade lesions, especially in young women. The median time for clearance is 6-18 months. Another change is for women aged 30 years and over who haven’t been screened in the last 5 years. Because they are a higher risk group, these women should be offered either a repeat smear within 6 months or referral to colposcopy. The guidelines indicate where HPV testing is appropriate from 1 July 2009 ie: for women 30 years and over with a low-grade smear report and no abnormal smear result within last 5 years.
Low-grade: flowchart
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.
Unsatisfactory Cytology review is recommended.• If low-grade cytology is confirmed on review, repeat colposcopy and cytology in 12 months. • Management may be individualised….
Note: recall 12 months rather than 6 months
Presenter
Presentation Notes
If the colposcopy is normal after a low-grade smear, the 6 month recall has been omitted and the woman returns for two annual smears. There is a new reference to unsatisfactory colposcopy, recommending cytology review.
Low-grade: colposcopy assessment
Presenter
Presentation Notes
New flowchart for colposcopic assessment of low-grade abnormalities.
Low-grade: histology confirmed
Note: recall at 12 months rather than 6 months
HISTOLOGY REPORT GUIDELINE
Histologically confirmed low grade squamous abnormalities
Treatment is not recommended, as such lesions are considered to be an expression of a productive HPV infection.
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.
Presenter
Presentation Notes
There is a clear statement that treatment is not recommended for confirmed low-grade lesions. Again, the smear at 6 months is omitted, while the recommendation for two annual smears at 12 and 24 months is the same.
High-grade: ASC-H/HSIL
CERVICAL SMEAR REPORT GUIDELINE
ASC-H Refer for colposcopy
HSIL Refer for colposcopy and targeted biopsy where indicated.
HSIL with suspected invasion
Urgent referral to a colposcopist or oncologist
More information on colposcopic assessment of ASC-H/HSIL and on various treatment methods
High-grade: colp. assessmentCOLPOSCOPIC
ASSESSMENTGUIDELINE
Satisfactory and abnormal
Targeted biopsy should be performed for histological diagnosis.Where biospy confirms CIN 1, manage based on MDM.
Satisfactory and normal colposcopy or negative biopsy
Cytology review is recommendedIf 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 recommendedIf review confirms ASC-H / HSIL, cone biopsy is recommended.If review confirms normal or ASC-US or LSIL, manage based
on MDM.
Presenter
Presentation Notes
Where colposcopy is clear following a high-grade smear result that has been confirmed on review, rather than annual smears as previously, the new guidelines recommend repeat colposcopy and cytology within 3 months. There is new guidance for an unsatisfactory colposcopy.
High-grade: ASC-H /HSIL colposcopy
Presenter
Presentation Notes
There is a new flowchart for management of high-grade results.
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
Presenter
Presentation Notes
Note: There is no clearly superior method of fertility sparing treatment of CIN2 and 3.
High-grade: post-treatment
FOLLOW UP GUIDELINERoutine
follow upA 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 ….
Presenter
Presentation Notes
Note: HrHPV testing from 1 July 2009 - see later slide
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 GUIDELINE
AGC or AIS or adenocarcinoma Refer to a colposcopist or to an oncologist.
Presenter
Presentation Notes
Women with a smear report suggesting AGC are far more likely to have a subsequent diagnosis of cervical cancer than those with low-grade squamous lesions. HrHPV testing may be used as an adjunct to further management from 1 July 2009.
High-grade: glandular colposcopy
Atypical glandular cells (AGC) (AG1-5)
Adenocarcinoma in situ (AIS)
Adenocarcinoma (AC 1-4)
Satisfactory & abnormalSatisfactory & normal Unsatisfactory
Colposcopy
Consistentwith cancer
Favouring aneoplastic
process (AIS)
Punch biopsyand refer to
gynaecologicaloncologist
Cytologyreview
Cytologyconfirmed
Notconfirmed
Conebiopsy
and D&C
Multi-disciplinaryteam review
Notconfirmed
Cytologyreview
Confirmedfavouring aneoplasticprocess
Multi-disciplinaryteam review
Conebiopsy
and D&C
Conebiopsy
and D&C
Presenter
Presentation Notes
A new flowchart for management of women with glandular lesions.
Special clinical circumstances
For example:SPECIAL CIRCUMSTANCE GUIDELINEPregnancy 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.
Presenter
Presentation Notes
The new guidelines have information on management of: women who are pregnant, immunosuppressed, HSIL in women under 20 years women with a previous hysterectomy post-menopausal women and women over 40 years with normal endometrial cells women exposed to diethylstilboestrol. Pregnancy It is not necessary to do smears, but smears and colposcopy are not contraindicated. Reasons not to delay routine smears during pregnancy include if the woman is well overdue for a smear, or if the previous smear was abnormal. High grade lesions should be referred for colposcopy to exclude lesions suspicious of invasive cancer, but if invasion not suspected, biopsy and treatment of a high-grade lesion can be delayed until after the birth.
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 high- grade disease.
Presenter
Presentation Notes
The new guidelines summarise indications and cases for cytology review or cyto-histo correlation at multidisciplinary case review meetings. In cases of discordance between cytology and colposcopy, discussion with the reporting pathologist is strongly recommended.
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.
Presenter
Presentation Notes
Negative predictive value = the proportion of the screened population with negative test results that do not have the disease In a recent summary of meta-analyses, the sensitivity of HrHPV testing was on average 14% higher than repeat cytology for detection of CIN2+ (Arbyn 2006). Sensitivity = the proportion of persons with the disease who test positive with the screening test ie, the test correctly identifies the condition. Specificity = the proportion of test negative (healthy) subjects who test negative with the screening test. A highly specific test means that there are few false positive results. Triage = the clinical process of sorting people into groups based on their need for or likely benefit from treatment.
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.
Presenter
Presentation Notes
HPV testing will not be an operational part of the NCSP until July next year. This is due to logistical reasons ie: to build lab capability and capacity align with new laboratory contracts to clarify funding develop testing standards time for developing education and training. HPV testing is already being used by some practitioners. The NCSP has therefore released a statement on Best Practice Guidance on HPV Testing.
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).
Presenter
Presentation Notes
High risk HPV testing distinguishes women at higher risk who need further assessment. Women don’t have to return to have an HPV test taken, ‘ reflex testing’ is done, ie on the original LBC sample or a sample co-collected at the time of the smear. The HPV test is done only if the cytology shows ASCUS/LSIL. In younger women (under 30 years), HPV testing is of limited value to triage low-grade smear results due to the high prevalence of transient HPV lesions in this age group. There will be increased use of LBC – up to 100% in 2010 as per the NCSP Strategy.
HPV triage ASC-US/LSIL
2. HPV testing post- treatment
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
Presenter
Presentation Notes
For women with: histologically proven HSIL and subsequently treated total hysterectomy for CIN2 or 3 Multiple studies show HrHPV testing more easily detects residual or recurrent lesions than cytology. Cytology and colposcopy are still needed to rule out false positives.
HPV testing: post-treatment
Cytology and HrHPV test 12 months post-treatmentand again at 24 months post-treatment
Colposcopy follow-up withcytology at 6-12 months
Refer to colposcopy
Repeat cytology andHrHPV testing 24 months
post treatment
HrHPV positive orcytology ASC-Hat either event
HrHPV negativecytology negative
on both testing occasions
Return to 3-yearlyscreening
HrHPV negative, cytology negative, repeatcytology in 12 monthsHrHPV negative, cytology ASC-US/LSIL,consider referral to colposcopy or continueannual screeningHrHPV negative, cytology > ASC-H, referto colposcopyHrHPV postive, refer to colposcopyirrespective of cytology result
HrHPV negativecytology ASC-US / LSIL
Presenter
Presentation Notes
Women who have 2 sets of -ve HrHPV and smear tests can return to a 3 year recall period. Women who have a +ve HrHPV or smear result are referred to colposcopy. In cases of negative HrHPV but low-grade cytology, 12 month repeat smear is an option.
HPV testing post-treatment (extended)
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
Presenter
Presentation Notes
The last main area of management that would benefit from use of HPV testing is where results are ‘discordant’ eg, if a woman has a high-grade smear report but the cervix appears normal on colposcopy. Discordant results should be reviewed by a multidisciplinary team.
Information and training
• Women
• Smear takers
• Laboratory staff
• Other health professionals
Presenter
Presentation Notes
Information needs: For women The main concerns are likely to be around HPV testing – what is the test, what does a positive result mean? A full set of resources will be developed next year. An interim fact sheet for women has been developed because HPV testing is currently happening. This is available on the NSU website. For smear takers Age at starting screening (invite at 20 years) Age at stopping screening 3 yearly interval (30-42 months ) Need to be aware of extended intervals for ASC-US/LSIL, additional information for on special circumstances. Key messages to give women about HPV testing Training to ensure they take a sample for HPV testing according to the guidelines from 1 July 2009. Correct processes for labelling and sending samples. Lab staff Training needed in processes eg, storage of LBC and co-collected samples, HPV testing etc.
Further information
• www.nsu.govt.nz
• Screening Matters
Thank you.
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