Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from...
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![Page 1: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/1.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
PRIMARY HPV SCREENING
A view from colposcopy
John TidyConsultant Gynaecological Oncologist
Chair National Colposcopy PAG
Member HPV primary screening group
![Page 2: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/2.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Why are we considering HPV primary screening?
• The arrival of the first cohort of women who have offered prophylactic HPV vaccination– 60 – 70% reduction in high grade CIN rates– Cytology, given it’s relatively poor sensitivity will
not be a viable screening test in this population– Primary HPV screening while very sensitive may
still lack specificity
![Page 3: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/3.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Why start now in the non vaccinated population?
• There will be a mixed screening population for many years– i.e. non HPV vaccinated women and HPV
vaccinated women
• Separating these populations will be a challenge
• A single screening strategy will be more efficient and more reliable
![Page 4: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/4.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
HPV Primary Screening Pilot
Colposcopy Management Recommendations
Index test HR-HPV +ve/cytology ≤low
grade <40yrs
Colposcopy Examination
Inadequate AbnormalNormal and adequate
No biopsy or biopsy <CIN1 ≥CIN2CIN1 Negative
biopsy
Abnormal Biopsy CIN1+
Discussion at MDT within
2m
Treat†Recall in 12mIndex test HR-HPV +ve/ cytology ≤low
grade
Index test HR-HPV +ve/cytology ≥high
grade
Discussion at MDT within 2m
Discharge to 3y recall
Discharge to 3y recall
HR-HPV -ve HR-HPV +ve
†Option of colposcopy at clinicians discretion
Version 1 May 2012
Reflex cytology and/or 12m follow up
Index HR-HPV +ve/cytology ≥high grade
or ≥40yrs
Repeat colposcopy in 12m
LLETZ
![Page 5: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/5.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Issues for colposcopy
• Caseload• Return of women with HR-HPV who are have a
normal colposcopy to routine recall• The management of low grade CIN• The performance of colposcopy particularly in
the vaccinated population
![Page 6: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/6.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
HPV Primary Screening Pilot
Colposcopy Management Recommendations
Index test HR-HPV +ve/cytology ≤low
grade <40yrs
Colposcopy Examination
Inadequate AbnormalNormal and adequate
No biopsy or biopsy <CIN1 ≥CIN2CIN1 Negative
biopsy
Abnormal Biopsy CIN1+
Discussion at MDT within
2m
Treat†Recall in 12mIndex test HR-HPV +ve/ cytology ≤low
grade
Index test HR-HPV +ve/cytology ≥high
grade
Discussion at MDT within 2m
Discharge to 3y recall
Discharge to 3y recall
HR-HPV -ve HR-HPV +ve
†Option of colposcopy at clinicians discretion
Version 1 May 2012
Reflex cytology and/or 12m follow up
Index HR-HPV +ve/cytology ≥high grade
or ≥40yrs
Repeat colposcopy in 12m
LLETZ
![Page 7: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/7.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Colposcopy referrals at STH
HPV triage and TOC
![Page 8: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/8.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Caseload
• The unknowns– Baseline HPV positivity rate
![Page 9: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/9.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Women eligible for screening
HPV high risk positive
Women with abnormal smears
High grade CIN
HPV Screening - The Dilemma
![Page 10: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/10.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
ARTISTIC
• Primary HPV testing– HC2
• Ages 20-64• Prevalence of HR-HPV
– 15.6%– Ages 25-64 – 12.7%– Ages 25-30 – 27.9%– Ages 30-34 – 18.5%– Ages 55-64 – 6.0%
![Page 11: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/11.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
ARTISTIC
• HR-HPV rates in abnormal cytology– Borderline 31%– Mild 70%
• HR-HPV rates in abnormal cytology– HPV sentinel site study– Borderline 40% increase compared with
ARTISTIC– Mild 17% increase compared with ARTISTIC
![Page 12: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/12.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Sentinel sites HPV +ve (%) rates by cytology and ageBorderline Mild Total
Age group N=6507 N=3544 N=10051
25-34N=5324
68.6% 89.2% 77.2%
35-49N=3912
41.9% 77.0% 52.0%
50-64N=815
31.0% 66.5% 40.2%
TotalN=10051
53.7% 83.9% 64.4%
![Page 13: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/13.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Baseline HPV rate
• Every UK study testing for HPV has found a higher rate of infection compared with other international studies and prior UK based studies
• Will the primary HPV screening study produce a similar result– i.e. a higher rate of HPV+ve women
![Page 14: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/14.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Performance of reflex cytology
• Only you can tell me how cytology might perform within this new strategy
• However we know that there is variation in practice between laboratories as indicated by the sentinel site study
![Page 15: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/15.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Sentinel sites HPV +ve (%) rates by laboratory and cytology
Site Borderline Mild Total
A 57.7% 88.6% 68.4%
B 34.8% 73.4% 52.1%
C 43.4% 81.8% 57.7%
D 61.2% 89.8% 74.3%
E 68.6% 91.6% 74.1%
F 73.3% 87.2% 75.9%
Thinprep 58.2% 87.7% 68.7%
Surepath 52.6% 78.5% 61.7%
![Page 16: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/16.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
PPV of HPV for detecting CIN by site and referral cytology
Borderline Mild Total
Site PPV
CIN2+
PPV
CIN3+
PPV
CIN2+
PPV
CIN3+
PPV
CIN2+
PPV
CIN3+
A 16.5% 7.4% 21.8% 7.6% 18.9 7.5%
B 11.2% 6.2% 9.1% 3.5% 9.9% 4.4%
C 11.6% 5.0% 15.9% 4.8% 13.9% 4.9%
D 9.3% 2.5% 10.9% 2.5% 10.2% 2.5%
E 21.5% 7.8% 25.4% 7.1% 22.7% 7.6%
F 20.9% 11.5% 30.0% 15.2% 23.4% 12.3%
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Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
HPV positivity in borderline cytology and PPV for high grade CIN
0
10
20
30
40
50
60
70
80
A B C D E F
Borderline HPV%
Borderline PPVCIN2+
Borderline PPVCIN3+P
erce
nta
ge
Study site
Av. CIN3 6.7%
![Page 18: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/18.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
HPV positivity in mild cytology and PPV for high grade CIN
0102030405060708090
100
A B C D E F
Mild HPV%
Mild PPV CIN2+
Mild PPV CIN3+
Per
cen
tag
e
Study site
Av. CIN3 5.4%
![Page 19: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/19.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
How might we reduce high referral rates?
• Only some PCTs will convert to primary HPV screening so only some of the caseload of a colposcopy clinic will be affected
• Should we start at age 30– Women aged 25 to 30 would have primary
cytology screening
• Could other tests reduce the referral rates– HPV genotyping– p16/Ki67 staining
![Page 20: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/20.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
HPV
Genotyping
• Only offer reflex cytology for HPV16/18+ve women
• Repeat HPV testing in 2 years for non 16/18+ve
• Refer HPV16/18 women without bothering with reflex cytology
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Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Safety of new colposcopy management pathways
• What is the risk of a woman who is HR HPV positive and has a normal colposcopic examination developing CIN2+ over the next 3 years?
![Page 22: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/22.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Safety of new colposcopy management pathways
• What is the risk of missing CIN2+ in women with a low grade cytology smear who has a normal colposcopic examination
• The risk of CIN3 developing over the next three plus years is reported to be between 3 and 10%. The negative predictive value for colposcopy to exclude high-grade CIN, when colposcopy is described as normal, is reported as 98-99%. NHSCSP No 20
Bellinson et al 2001Cantor et al 2008
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Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Risk of developing CIN3+ based on HPV type
• Recent prospective population based studyRisk at 12 years
• HPV 16 26.7%• HPV 18 19.1%• HPV 31 14.3%• HPV 33 14.9%• Other high risk HPV 6.0%• HC2+ negative 3.0%
• The risk of developing CIN 3+ at 3 years appears to be 5% for HPV16 and <3% for other high risk types.
Kjaer et al 2010
![Page 24: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/24.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Detection of CIN2+ in women referred in pilot triage study
• 360 women attended colposcopy• 72.2% had a negative colposcopy• Rates of CIN2+ 4.4%, CIN3 2.4% at 3 years
were reported for those women with a negative colposcopy at entry
• In the normal UK screened population; in 2007-08 there were 39,456 cases of CIN2+ among 3,670,846 women screened, a rate of 1.2%
Kelly et al 2011
![Page 25: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/25.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Long term outcome for women with normal colposcopy after referral with
low grade cytology
• 622 women• 2292 years of follow up• 96% had negative or low grade cytology in
the future• 3.3% had CIN2+ in the future• Cumulative rate of CIN2+ at 5 years if
negative colposcopy and non-dyskaryotic cytology at first visit– 1.3% borderline– 8.5% mild Smith et al 2006
![Page 26: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/26.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Summary• The risk of developing CIN2+ over three years
based only HR HPV infection alone is low – 3-5%
• Colposcopy has a high NPV to exclude high grade CIN when colposcopy is normal – 98-99%
• In the pilot sites the rate of CIN2+ in the women with low grade cytology, HP HPV + with normal colposcopy was low – 4.4%, similar to previous follow up strategies
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Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Management of CIN1
• Should we consider CIN1 a manifestation of transient HPV infection?
• Does CIN1 ever need to be treated– Highest TOC failure rates for LLETZ are
associated with treatment of CIN1
• Can we safely increase the interval between colposcopic examinations?
• Should all women with CIN be returned to community based follow-up
![Page 28: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/28.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Management of CIN1
• What should the re-call interval be– 12 months
• What should the re-call test be– HPV + reflex cytology alone is suggested in
current algorithm– If this is done in colposcopy then we have the
same situation as we had with TOC i.e. a diagnostic test is performed and then a screening result becomes available a few days later
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Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Management of CIN1
• Could the re-call interval be– 36 months
• Tombola study– 166 women with CIN1 followed for 3 years– 76 (46%) HR-HPV positive– 16% HPV 16, 10% HPV 18– 12 (20%) women developed HG-CIN– Only predictor of developing HG-CIN was HPV16
or HPV18. OR 4.3.
• Could we use genotyping?
![Page 30: Sheffield Gynaecological Cancer CentreSheffield Teaching Hospitals PRIMARY HPV SCREENING A view from colposcopy John Tidy Consultant Gynaecological Oncologist.](https://reader036.fdocuments.in/reader036/viewer/2022062519/5697c0261a28abf838cd5b09/html5/thumbnails/30.jpg)
Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Performance of colposcopy in post vaccination screening population
• Technique not changed since 1920s• Rely on tissue changes i.e. whiteness and
vascular patterns associated with application of acetic acid
• Only measure of performance in NHSCSP No. 20 is PPV >65% to correctly identify HG-CIN based on colposcopic impression
• PPV is dependent on disease prevalence
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Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Performance of colposcopy in post vaccination screening population
• Some recent studies suggest that HPV16 and 18 are associated with significant aceto-white change
• Other HR-HPVs may produce more subtle changes
• Subtle aceto-white change is associated with LG-CIN and metaplasia
• Will colposcopy become more dependent on directed biopsies?
• Will we have to use random biopsies?
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Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Challenges to management involving HPV testing
• Almost 100% of cervical cancers are associated with HR-HPV
• IARC has stated that HR-HPVs are cancer causing viruses
• Nobel prize awarded to Prof H zur Hausen for his work linking HPV to cervical cancer
• Prophylactic vaccination programme against HR-HPV
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Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Challenges to management involving HPV testing
• HPV infection is ubiquitous• 80% of sexually active people will be infected
at some stage• Duration of infection is 13 months• HPV alone cannot cause a cancerous growth
in the laboratory setting• The risk of developing CIN3+ after 12 years
exposure is 27%• The duration between HPV infection and
CIN3 is 7-8 years
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Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Challenges to management involving HPV testing
• The development of CIN3 is not a failure of the cervical screening programme
• Treating CIN3 is associated with a lower test of cure failure rate than treating CIN1
• The development of invasive cervical cancer is
• We should not place the same emphasis on the development of CIN3 compared with the development of cervical cancer
• CIN3 will progress to cancer at the rate of– 10yrs – 18%, 20yrs – 36%, 30yrs – 54%
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Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals
Summary• HPV is a common infection associated with intimate
contact• The duration of infection is long but most people will
eradicate the infection• Low grade changes are a manifestation of HPV
infection once high grade CIN has been excluded• The risk of HPV infection leading to HG-CIN is low
and occurs over a long time period• The development of CIN3 is not a failure of the
screening programme as it is easily treated without increased risk of recurrence, without any increase in morbidity when compared with low grade CIN
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Sheffield Gynaecological Cancer Centre Sheffield Teaching Hospitals