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Dr DONALD ANGSTETRA Bsc(Med) | MBBS|FRANZCOG
A/Clinical Lead in Gynaecology |Women’s health | Gold Coast University Hospital
Senior Lecturer | Griffith University
Visiting Medical Officer | Allamanda Hospital
 National Cervical Screening Program
 Introduced in 1991
 2-yearly pap smear test
 In asymptomatic women who have ever been sexually active
 Age 18-69yo
Pre-NCSP
National Screening program
Introduced in 1991
National Screening program
Introduced in 1991
 Cervical cancer − last 20 years
 1991-2002 − Incidence & mortality rates ~50%
 > 2002 − Rates have plateau
 Incidence of Cervical ca 9/100,000
 Mortality rate  2/100,000
Pre-NCSP
 New Knowledge of the natural history of Cervical Ca − HPV infection
 New Evidence - appropriate screening age ranges and ‘optimal’ intervals
 New technologies
 HPV DNA typing
 Liquid Based Cytology (LBC)
 Computer Assisted Image Analysis
 The National HPV Vaccination Program − Prevalence of HPV in the community
 2007 – Girls
 2013 – Boys
 The current NCSP is intensive compared to other countries
 Renewal commenced in 2011
 Assess evidence for screening tests, interval and targeted age-group
 Assess and recommend a cost effective screening pathway and program
model
 Improve national data collection system and registry functions
 Assess feasibility and acceptability of the new program
 Medical Services Advisory Committee (MSAC)
 Recommendations were finalised and submitted to April 2014
 The ‘NEW’ Screening Program will begin from 1 May 2017
 Replace “Pap Smear” with HPV DNA test as primary screening test
 Include partial genotyping for HPV16, 18 +/- 45
 +ve HPV DNA test will undergo further triaging -> Reflex liquid based cytology
 Lifts the age of commencement to 25; Exit HPV test at age 70-74
 vaccinated and unvaccinated women
 Increases screening interval from 2yrs  5yrs;
 HPV Self-Collection
 “Never screened” & “Under-Screened” population
 Registry – Invitation, Call & Recall
 Will 5yr interval increase OR decrease participation?
 2008-2012 Patient participation (age 20-69)
 2yr interval – 57.7%
 3yr interval – 70.2%
 5yr interval – 83.3%
more complex!!
Based on modelling, the ‘NEW’ program is:
 Safe
 More effective
 Aim to  further Cervical ca by additional 15%
 More cost-effective
 Collect a LBC sample from cervix
 If HPV +ve
 Reflex cytology will be carried out
 Clinician will receive a report with
 HPV status (+/- genotype)
 Cytology (if HPV +ve)
 A single recommendation of management
 Double stranded DNA virus
 100 different HPV genotypes
 Oncogenic HPV are acquired through sexual contact
 Strong evidence that HPV infection is necessary, though not sufficient, for
development of Cervical ca
 HPV 16 & 18 cause ~70% of all cervical cancers
 80% lifetime risk of acquiring HPV
 Majority of HPV infections are cleared within 2yrs
 CIN1  acute HPV infection and viral replication
 CIN2&3  HPV DNA incorporation into the host DNA and cell immortalisation
 Cervical Ca - rare outcome of infection
 Natural progression of High Grade abnormalities over 1-25
years
 Common Diagnosis of HSIL 25-29yo; Cervical Ca 44-49yo
CIN2 CIN3
Regression 43% 32%
Persistence 35% 56%
Progression 5% >12%
 Currently use HPV DNA testing
 NOT a diagnostic tool
 “Test of cure” in women who have been treated for High Grade
lesion
 Can be requested at other times, But NO Medicare rebate
($80-$100)
 Order of testing is important
 Applying the more sensitive test first (HPV DNA test)
 Excellent Negative Predictive Value (NPV of >99%)
 Reduce the number of False Negatives
 Applying the more specific test second (LBC)
 Good Positive Predictive Value
 Reduce the number of False Positives
  unnecessary referral and follow-up
 ~2.3/100,000 (rare)
 NCSP had NO effect on incidence of
Cervical Ca in this age group
 Increased risk of future pregnancy
 HPV vaccination has been shown to
reduce significant cervical abnormalities
 Primary prevention of HPV infection
 Commenced in 2007 at 12-13yo girls
 Catch-up program extended to women up to 26yrs of age for a
period of 2yrs
 Extended in 2013 to cover 12-13yo boys
 Uses Gardasil
 Quadrivalent vaccine (HPV types 6, 11, 16, 18)
2006 vs. 2011:
A decline in high grade
abnormalities in <20 &
20-24 age groups
women men
% of Australians diagnosed with genital warts at first visit to a sexual
health clinic (BMJ 2013; 346:f2032)
 20% of Australian women did not participate in screening
in the 5yr interval b/w 2007-2011
 Victorian Cervical Cytology Register
 In 2009, ~80% of women diagnosed invasive cervical Ca had either
never been screened OR were lapsed screeners
 ATSI have
 2x incidence of Cervical Ca
 4x mortality rate in comparison to non-indigenous
 Self-Collection  participation rates
 By using HPV DNA testing as primary diagnostic tool
 Disease no longer cytological / histological diagnosis
 BUT
 Sexually Transmitted Infection
 Altered patient perception -> stigma?
 Procedure for collecting sample for HPV testing remains the same
 Sample is deposited in LBC medium rather than “slide” smear
 +ve HPV test indicate the need for more testing; however patient reassurance is important
as majority of these infections regress
 The 5 year screening interval ONLY applies to women with negative results
 Women with HPV +ve results will require further investigation and closer monitoring
 SYMPTOMATIC women (i.e. post coital bleeding, intermenstrual bleeding) need
investigation regardless of AGE
 The ‘NEW’ NCSP applies only to asymptomatic women
 HPV vaccinated women will still require screening
http://www.goldcoastwomencare.com.au

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Future cervical screening program

  • 1. Dr DONALD ANGSTETRA Bsc(Med) | MBBS|FRANZCOG A/Clinical Lead in Gynaecology |Women’s health | Gold Coast University Hospital Senior Lecturer | Griffith University Visiting Medical Officer | Allamanda Hospital
  • 2.
  • 3.  National Cervical Screening Program  Introduced in 1991  2-yearly pap smear test  In asymptomatic women who have ever been sexually active  Age 18-69yo
  • 4. Pre-NCSP National Screening program Introduced in 1991 National Screening program Introduced in 1991  Cervical cancer − last 20 years  1991-2002 − Incidence & mortality rates ~50%  > 2002 − Rates have plateau  Incidence of Cervical ca 9/100,000  Mortality rate  2/100,000
  • 6.
  • 7.  New Knowledge of the natural history of Cervical Ca − HPV infection  New Evidence - appropriate screening age ranges and ‘optimal’ intervals  New technologies  HPV DNA typing  Liquid Based Cytology (LBC)  Computer Assisted Image Analysis  The National HPV Vaccination Program − Prevalence of HPV in the community  2007 – Girls  2013 – Boys  The current NCSP is intensive compared to other countries
  • 8.  Renewal commenced in 2011  Assess evidence for screening tests, interval and targeted age-group  Assess and recommend a cost effective screening pathway and program model  Improve national data collection system and registry functions  Assess feasibility and acceptability of the new program  Medical Services Advisory Committee (MSAC)  Recommendations were finalised and submitted to April 2014  The ‘NEW’ Screening Program will begin from 1 May 2017
  • 9.  Replace “Pap Smear” with HPV DNA test as primary screening test  Include partial genotyping for HPV16, 18 +/- 45  +ve HPV DNA test will undergo further triaging -> Reflex liquid based cytology  Lifts the age of commencement to 25; Exit HPV test at age 70-74  vaccinated and unvaccinated women  Increases screening interval from 2yrs  5yrs;  HPV Self-Collection  “Never screened” & “Under-Screened” population  Registry – Invitation, Call & Recall
  • 10.  Will 5yr interval increase OR decrease participation?  2008-2012 Patient participation (age 20-69)  2yr interval – 57.7%  3yr interval – 70.2%  5yr interval – 83.3%
  • 11. more complex!! Based on modelling, the ‘NEW’ program is:  Safe  More effective  Aim to  further Cervical ca by additional 15%  More cost-effective
  • 12.
  • 13.  Collect a LBC sample from cervix  If HPV +ve  Reflex cytology will be carried out  Clinician will receive a report with  HPV status (+/- genotype)  Cytology (if HPV +ve)  A single recommendation of management
  • 14.  Double stranded DNA virus  100 different HPV genotypes  Oncogenic HPV are acquired through sexual contact  Strong evidence that HPV infection is necessary, though not sufficient, for development of Cervical ca  HPV 16 & 18 cause ~70% of all cervical cancers  80% lifetime risk of acquiring HPV  Majority of HPV infections are cleared within 2yrs  CIN1  acute HPV infection and viral replication  CIN2&3  HPV DNA incorporation into the host DNA and cell immortalisation
  • 15.  Cervical Ca - rare outcome of infection  Natural progression of High Grade abnormalities over 1-25 years  Common Diagnosis of HSIL 25-29yo; Cervical Ca 44-49yo CIN2 CIN3 Regression 43% 32% Persistence 35% 56% Progression 5% >12%
  • 16.  Currently use HPV DNA testing  NOT a diagnostic tool  “Test of cure” in women who have been treated for High Grade lesion  Can be requested at other times, But NO Medicare rebate ($80-$100)
  • 17.  Order of testing is important  Applying the more sensitive test first (HPV DNA test)  Excellent Negative Predictive Value (NPV of >99%)  Reduce the number of False Negatives  Applying the more specific test second (LBC)  Good Positive Predictive Value  Reduce the number of False Positives   unnecessary referral and follow-up
  • 18.  ~2.3/100,000 (rare)  NCSP had NO effect on incidence of Cervical Ca in this age group  Increased risk of future pregnancy  HPV vaccination has been shown to reduce significant cervical abnormalities
  • 19.  Primary prevention of HPV infection  Commenced in 2007 at 12-13yo girls  Catch-up program extended to women up to 26yrs of age for a period of 2yrs  Extended in 2013 to cover 12-13yo boys  Uses Gardasil  Quadrivalent vaccine (HPV types 6, 11, 16, 18)
  • 20. 2006 vs. 2011: A decline in high grade abnormalities in <20 & 20-24 age groups
  • 21. women men % of Australians diagnosed with genital warts at first visit to a sexual health clinic (BMJ 2013; 346:f2032)
  • 22.  20% of Australian women did not participate in screening in the 5yr interval b/w 2007-2011  Victorian Cervical Cytology Register  In 2009, ~80% of women diagnosed invasive cervical Ca had either never been screened OR were lapsed screeners  ATSI have  2x incidence of Cervical Ca  4x mortality rate in comparison to non-indigenous  Self-Collection  participation rates
  • 23.  By using HPV DNA testing as primary diagnostic tool  Disease no longer cytological / histological diagnosis  BUT  Sexually Transmitted Infection  Altered patient perception -> stigma?
  • 24.  Procedure for collecting sample for HPV testing remains the same  Sample is deposited in LBC medium rather than “slide” smear  +ve HPV test indicate the need for more testing; however patient reassurance is important as majority of these infections regress  The 5 year screening interval ONLY applies to women with negative results  Women with HPV +ve results will require further investigation and closer monitoring  SYMPTOMATIC women (i.e. post coital bleeding, intermenstrual bleeding) need investigation regardless of AGE  The ‘NEW’ NCSP applies only to asymptomatic women  HPV vaccinated women will still require screening