Transcript new-cx-screening-program - Women`s Health | Gynaecology

ARE YOU PREPARED FOR THE
NEW CERVICAL SCREENING
PROGRAM?
Dr Shian Miller
Obstetrician & Gynaecologist
BSc (Hon), MBBS, FRANZCOG
OVERVIEW
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Background:
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The NEW Cervical Screening Program
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Background
Implementation
Your Questions Answered
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History of Cervical Screening
Cervical Screening in Australia
Cervical cancer in Australia
HPV and cervical cancer
HPV vaccination
But why change?
Why HPV?
Why every 5 years?
Why start at 25 years of age?
Why up to 75 years old?
What is currently done in the UK
Summary
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The future of Cervical Screening
Conclusion
BACKGROUND
The Cervical Screening Program
THE HISTORY OF CERVICAL SCREENING
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George Papanicolaou (1883-1962)
Born in Greece, migrated to USA
Noticed physiological cellular changes in vaginal fluid
over the course of a menstrual cycle
One woman in his study had uterine cancer & he
discovered that abnormal cancer cells in her vaginal fluid
were clearly visible under a microscope
Initial presentation at a medical conference in 1928 was
met with scepticism
Published a paper in 1941 with gynaecologist Herbert
Traut on the diagnostic value of vaginal smears in
cervical and uterine carcinomas – described technique
used today hence ‘Pap’ smear
Romanian scientist Aurel Babes independently made
similar discoveries in 1927 but used a different collection
method
CERVICAL SCREENING IN AUSTRALIA
Since 1960s, Australia has been doing pap
smears
 Ad hoc, opportunistic screening
 National Cervical Screening Program began in
1991 with recommended guidelines and a
national register
 Organised approach to screening with
promotion of public awareness
 Also improved quality control of smear taking,
processing, and reporting, as well as
standardising the management of screendetected abnormalities
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CERVICAL CANCER IN AUSTRALIA
14th most common cancer diagnosed in females
 Approx 800 new cases of cervical cancer
diagnosed per year in Australia
 Approx 200-250 women die of cervical cancer per
year
 5-year survival rate for cervical cancer in
Australia is 72%
 Most cervical cancers (~80%) are SCC, ~15%
adenocarcinomas, 5% adenosquamous and ‘other’
 Since introduction of Cervical Screening
Program, significant reduction in cervical cancer
incidence and mortality
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CERVICAL CANCER INCIDENCE
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Women aged 20-69, from 1982 to 2008 (AIHW)
CERVICAL CANCER MORTALITY
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Women aged 20-69, from 1982 to 2007
HPV IN CERVICAL CANCER
HPV is detected in >99% of cervical cancers
 More than 100 types of HPV but only some
associated with cervical cell changes –
particularly HPV types 16 and 18
 Estimated more than 80% of women are infected
with HPV in their lifetime – but most clear the
infection by on average 12 months
 It is when HPV infection persists that highgrade cervical changes occur
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HPV VACCINE
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National HPV Vaccination Program started 2007
Vaccination of 12-13 yo, catch-up program to women
up to 26 years for a period of two years
Also now vaccinating boys since 2013
Has already reduced the rate of high-grade cervical
abnormalities in young women
There has been a 90% reduction in genital warts in
men & women under 21 years of age
Predicted to greatly reduce the incidence of cervical
abnormalities and cervical cancer in the future
Evidence that two doses of HPV vaccine (Gardasil
or Cervarix) are as effective as three doses – change
already made in the UK in September 2014
THE NEW CERVICAL
SCREENING PROGRAM
THE NEW SCREENING PROGRAM
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Scheduled to be implemented in May 2017
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Renewal of the NCSP first raised in 2013
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Committees formed
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Over 130 variations of cervical screening models
evaluated to ensure a cervical screening
program that is safe, acceptable, effective,
efficient, and based on current evidence (and of
course, cost-effective)
Credit to the committees – their comprehensive
data analysis can be found at:
http://www.msac.gov.au/internet/msac/publishin
g.nsf/Content/1276-public
THE NEW SCREENING PROGRAM (CONT)
The Cancer Council Australia has finalised the
clinical management guidelines – but still need
endorsement from RACGP, RANZCOG, RCPA
and societies, ASCCP and ASGO
 Medicare Benefits Schedule Items: working to
finalise the item descriptors and fees to support
the renewal
 Early reports that HPV testing will be covered by
MBS (as long as it is within the guidelines eg.
done no less than 4.5 years apart)
 Pap smears will still be covered by MBS until at
least September 2017
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THE NEW SCREENING PROGRAM (CONT.)
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Working on:
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Supporting workforce and practice change
Resource development for both health care professionals
and consumers
Drafting standards for pathology tests
Legislation: The National Cancer Screening Register Bill
2016 and the National Cancer Screening Register
(Consequential and Transitional Provisions) Bill 2016 (the
Bills) have been included in the new Parliament’s Spring
2016 legislation program
Cancer Council Australia have been contracted to develop
the Engaging with under-screened and never-screened
women in the National Cervical Screening Program Toolkit
for health care professionals
The Quality Framework for the NCSP (protocols for
monitoring the safety of the new program) is almost
finalised and is likely to be available in February 2017
THE NEW SCREENING PROGRAM (CONT)
National Cancer Screening Register
 Tender awarded to Telstra Health
 Also managing the National Bowel Cancer
Screening Program
 Currently, cervical screening registers are State
and Territory based
 The National Cancer Screening Register will
‘support’ the current registers ‘at the discretion of
individual State & Territory registers’
 Will be ready by May 2017 ‘subject to state and
territory agreement to migrate data’ and ‘the
passage of the National Cancer Screening
Register legislation’
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OLD VERSUS NEW
Old NCSP
New cervical screening program
Pap smear performed for screening
HPV test performed for screening
(speculum exam & endocervical swab) (speculum exam & endocervical swab)
With glass slide +/- ThinPrep/Surepath With ThinPrep/Surepath
Pap every TWO years
HPV test every FIVE years
Age 18-70
Age 25-75
Abnormal pap: refer to colposcopy
HPV test positive: ‘reflex cytology’ on
sample already taken – if cytology
abnormal, refer to colposcopy
Symptomatic (abnormal
Symptomatic (abnormal
bleeding/discharge): refer to colposcopy bleeding/discharge): refer to colposcopy
Poor attendees: no follow-up
Poor attendees: offer self-collection for
HPV testing
HPV TESTING
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Speculum & endocervical sample with broom
Sample into liquid-based cytology medium
At the Path lab, the sample is processed through a
machine – results will be POSITIVE or NEGATIVE
Will also do partial genotyping for HPV 16/18 – if
present, refer to colposcopy even if cytology negative
If NEGATIVE, next screen in FIVE years
If POSITIVE, reflex cytology…
REFLEX CYTOLOGY
HPV infection may not be associated with
cytological abnormalities
 HPV testing has high sensitivity and high NPV
– so reduces false negatives but has high false
positive
 Reflex cytology to reduce false positive results
 The initial cytology will be done by a machine –
results will be verified by a cytologist ?only if
positive ?only if negative
 If reflex cytology is:
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Negative – repeat HPV testing in 1 year – if HPV
still positive, refer for colposcopy regardless of
cytology results (means HPV has persisted)
 Positive for cellular changes – refer for colposcopy
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SELF-COLLECTION FOR HPV TESTING
Patients aware of this method due to media
coverage
 Self-collection is only intended for women who
would otherwise not attend for screening
 Collection kit is sent to the woman who then
performs a vaginal swab herself (not
endocervical) – results still need to be followed
up by GP practice
 Sensitivity as low as 60%
 Women who test positive will still need to
attend for LBC triage (can’t avoid a speculum
exam!)
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YOUR QUESTIONS ANSWERED
The rationale behind the change
WHY SHOULD WE CHANGE?
Balancing the risk of investigation and
treatment with the risk of cervical cancer
 Incidence of cervical cancer 15 per 100,000
compared to abnormal results in 5000 per
100,000 screen
 Current screening is not having much impact on
adenocarcinomas
 Cervical cancer incidence and mortality has
plateaued – can we do better?
 Incidence of high grade abnormality to fall
markedly due to HPV vaccine – will need to
ensure screening test still performs well despite
low prevalence
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WHY HPV?
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HPV infection is necessary for the development of
cervical cancer
HPV is positive in 99.7% of cervical cancers
HPV testing compared to current screening has a
greater negative predictive value and increased
detection of high-grade CIN
HPV testing (unlike current screening) has been
shown to significantly reduce the incidence of
adenocarcinomas
Low-grade cervical changes may indicate acute HPV
infection but it is the persistence of HPV that
causes high-grade changes and cervical cancer –
HPV testing shows persistence better than cervical
cytology
WHY CHANGE FROM EVERY 2 YEARS TO
EVERY 5 YEARS?
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HSIL resolves spontaneously in a large number of
women, especially younger women – can also persist
for a lifetime without development into SCC
At 12 months,
LSIL/CIN1 regressed in 80%, progressed in 3.6%
CIN2 43% regressed, 35% persist, 22% progress
CIN3 33% regressed, 56% persist, 12% progress
Average duration from HSIL to progression to
cancer is 10 to 15 years
Longer screening intervals appropriate due to high
NPV of HPV testing – extending screening to every 5
years avoids overdiagnosis of regressive CIN
WHY CHANGE THE STARTING AGE FROM
18YO TO 25YO?
High prevalence of HPV infection but most
people spontaneously clear the infection
 Only in those where HPV infection persists (for
generally more than 3 years) do cervical changes
occur
 Less than 0.2% of cervical cancers occur in
women under age 25
 High incidence of HSIL in younger women (<30)
without corresponding incidence of cancer
 High chance of regression of HSIL in young
women – already currently offer conservative
management for CIN2 under 25yo
 Risk of CIN3 progression is age-related
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AGE-SPECIFIC INCIDENCE RATES OF
CERVICAL CANCER
FROM 18YO TO 25YO (CONT)
 Cervical
screening for women 20-24 has had
no effect on cancer incidence (10 cases per
year) with 0-2 deaths per year over the same
period
 Other countries do not screen under age 25
yet have the same incidence and
mortality for cervical cancer
 Protective effect of vaccination will reduce
the benefits of screening in this age group
 Unnecessary treatment of lesions that have
a high chance of regression may impact on
future pregnancies
WHAT ABOUT THE EARLY STARTERS?
Even if HPV infection occurs, most clear the
infection
 Even if HPV persists, most cervical changes,
even HSIL, spontaneously regress
 So only a small percentage of HPV infection
persists and only a small percentage of these
persistent infections will have HSIL that
progresses
 Progression of HSIL to cervical cancer averages
10 to 15 years
 High index of suspicion for referral for further
investigation if persistent bleeding or discharge
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WHAT ABOUT THE UNVACCINATED?
Too confusing and costly to have one program for
vaccinated and one program for unvaccinated
 Unvaccinated women will benefit from the
lowering prevalence of high-risk HPV due to
vaccination
 HPV testing also validated in an unvaccinated
population
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EXTENDING UP TO 75YO
The new cervical program targets women aged 25
to 69yo
 Then there is an ‘exit’ screen between age 69 and
75
 There is still a significant incidence of cervical
cancer after 70yo
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WHAT IS BEING DONE IN THE UK
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Since Sept 2014, only 2 doses of HPV vaccine rather than 3
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Since 2008, has been using LBC
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Since 2003, starting age for screening raised from 20 to
25yo
Screening every 3 years from 25-49yo then every 5 years
from 50-65yo – no further screening after 65yo
Since 2014, if cytology is low-grade or borderline, then HPV
triage is used – if HPV positive, then refer to colposcopy, if
HPV negative, return to normal screening
Currently investigating primary HPV screening
SUMMARY
THE FUTURE OF CERVICAL SCREENING
Incidence of high-grade HPV thus HSIL and
cervical cancer predicted to fall due to HPV
vaccination
 Will not be able to go back to cytology screening
as there will be a lack of pathologists skilled in
cytology
 HPV testing likely to include HPV genotyping to
further refine management
 Prediction that in the far future, women may
need only 2-3 screening tests in their lifetime!
 Prediction that my colposcope may sit idle in ten
years time OR I will be the only expert in
colposcopy..
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CONCLUSION
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The new cervical screening is coming in May 2017 –
HPV test every FIVE years for age >25
Do not delay pap smears in the meantime
Will be a transition period where pap smears will
still be able to be done until December 2017
Women of any age who have symptoms (abnormal
bleeding, discharge) should be investigated
HPV is central to cervical cancer – the natural
history of HPV infection and cervical changes have
greatly influenced the changes in the new screening
program
Pap smears will be a thing of the past – HPV testing
is the future