MQlicker This session will utilise the mQlicker interactive audience program Questions will be presented and you will be able to respond electronically.

mQlicker

This session will utilise the mQlicker interactive audience program

Questions will be presented and you will be able to respond electronically through your mobile device

Enable the internet on your mobile device

Open the web browser

Go to https://respond.cc

When a question is presented, enter the Session Key for that question

Select one of the multiple choice answers and Submit

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The New Cervical Screening Program:Will the pap smear be irrelevant?

Dr Shian Miller Obstetrician & GynaecologistBSc (Hon), MBBS, FRANZCOG

Disclaimer

This session is not funded by a pharmaceutical nor medical device company

Dr Shian Miller is an independent obstetrician and gynaecologist practicing general obstetrics and general gynaecology – with a special interest in colposcopy

Dr Shian Miller is not involved in the development nor implementation of the Renewal of the Cervical Screening Program (other than as a practising gynaecologist) and has no association with any committees involved with the Renewal

Will the pap smear be irrelevant?

Yes

Overview

Background

Why do we need a change?

What is going to change?

But what about…? Your protests answered!

The future (or lack of future) of cervical screening

mQlicker

This session will utilise the mQlicker interactive audience program

Questions will be presented and you will be able to respond electronically through your mobile device

Enable the internet on your mobile device

Open the web browser

Go to https://respond.cc

When a question is presented, enter the Session Key for that question

Select one of the multiple choice answers

https://respond.cc/

mQlicker checkSESSION KEY: 18401

Q1: I am a:

1. General practitioner

2. Specialist

3. Nurse or nurse practitioner

4. Student

5. Non-medical layperson

6. Other

(mQlicker answers)

mQlicker QuestionSESSION KEY: 52769

Q2: My knowledge about the new cervical screening program is:

1. There’s a new cervical screening program?

2. Heard about it but don’t know the details

3. Know a little bit about it

4. Know the main details well and/or you came to my practice and talked about it

5. Confident in all aspects of the new program

(mQlicker answers)


Q3: My feelings about the new program are:

1. Angry/annoyed

2. Worried

3. Neutral

4. It’s time for a change; I appreciate the need for a change

5. Excited

(mQlicker answers)


Q4: From what I know about the new cervical screening program, I think:

1. We should stay with the current screening program

2. We should delay the release of the new program

3. We should change to the new program as announced

4. I don’t know enough about the new program to say either way

5. I don’t mind either way

(mQlicker answers)

The History of Cervical Screening

George Papanicolaou (1883-1962)Born in Greece, migrated to USANoticed physiological cellular changes in vaginal fluid over the course of a menstrual cycleOne woman in his study had uterine cancer & he discovered that abnormal cancer cells in her vaginal fluid were clearly visible under a microscopeInitial presentation at a medical conference in 1928 was met with scepticismPublished a paper in 1941 with gynaecologist Herbert Traut on the diagnostic value of vaginal smears in cervical and uterine carcinomas – described technique used todayRomanian 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 screen-detected abnormalities

Current Australian screening

National Cervical Screening Program (NCSP)

Target age 18-69

Pap smear every 2 years

If LSIL, repeat in 12 months

If LSIL, over 30yo, no negative pap in last 2-3 years, repeat pap in 6 months or refer for colposcopy

HSIL, refer for colposcopy


Q5: What is the current participation rate (approx) in the National Cervical Screening Program?

1. 20%

2. 40%

3. 60%

4. 80%

5. Almost 100%

(mQlicker answers)

Cervical screening participation rates

Women aged 20-69 (AIHW)

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’

Cervical cancer incidence

Women aged 20-69, from 1982 to 2008 (AIHW)

Cervical cancer mortality

Women aged 20-69, from 1982 to 2007

Effects of the NCSP

Has resulted in one of the lowest mortality rates from cervical cancer in the world: 1.8 per 100,000 women

Incidence of SCCs has halved: 14 per 100,000 in 1982 to 6.9 per 100,000 women in 2011 (although absolute value steady: 963 vs 801)

Much more modest reduction in glandular cervical cancers

More than 90% of women diagnosed with invasive SCC have either no screening history or an inadequate screening history in the 10 years prior to diagnosis

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 high-grade cervical changes occur

HPV vaccineNational HPV Vaccination Program started 2007Vaccination of 12-13 yo, catch-up program to women up to 26 years for a period of two yearsAlso now vaccinating boys since 2013Has already reduced the rate of high-grade cervical abnormalities in young womenThere has been a 90% reduction in genital warts in men & women under 21 years of agePredicted to greatly reduce the incidence of cervical abnormalities and cervical cancer in the futureEvidence that two doses of HPV vaccine (Gardasil or Cervarix) are as effective as three doses – change already made in the UK in September 2014


Q6: The uptake of the HPV vaccine in the school cohort is (approx):

1. 10%

2. 30%

3. 50%

4. 70%

5. 90%

(mQlicker answers)

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

Cervical cancer rates by histological type

Cervical screening is most effective for prevention of SCC but not adenocarcinomas

The New Screening Program

Scheduled to be implemented in May 2017

Renewal of the NCSP first raised in 2013

Committees formed

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/publishing.nsf/Content/1276-public

Old versus newOld NCSP New cervical screening

program

Pap smear performed for screening(speculum exam & endocervical swab)With glass slide +/- ThinPrep/Surepath

HPV test performed for screening(speculum exam & endocervical swab)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 bleeding/discharge): refer to colposcopy

Symptomatic (abnormal bleeding/discharge): refer to colposcopy

Poor attendees: no follow-up Poor attendees: offer self-collection for HPV testing


Q7: On hearing about the changes in the new Cervical Screening Program, I am:

1. Angry, annoyed

2. Worried

3. Neutral

4. Starting to come around to the idea

5. Pleased

(mQlicker answers)

Why HPV?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 ‘reflex cytology’?HPV infection may not be associated with cytological abnormalitiesHPV testing has high sensitivity and high NPV – so reduces false negatives but has high false positiveReflex cytology to reduce false positive resultsIf partial HPV genotyping performed, refer to colposcopy with HPV 16/18 (45) even if cytology negative (evidence not enough at present to make partial HPV genotyping routine)If reflex cytology is:

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

Why change from every 2 years to every 5

years?HSIL resolves spontaneously in a large number of women, especially younger women – can also persist for a lifetime without development into SCCAt 12 months,LSIL/CIN1 regressed in 80%, progressed in 3.6%CIN2 43% regressed, 35% persist, 22% progressCIN3 33% regressed, 56% persist, 12% progressAverage duration from HSIL to progression to cancer is 10 to 15 yearsLonger 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 infectionOnly in those where HPV infection persists (for generally more than 3 years) do cervical changes occurLess than 0.2% of cervical cancers occur in women under age 25High incidence of HSIL in younger women (<30) without corresponding incidence of cancerHigh chance of regression of HSIL in young women – already currently offer conservative management for CIN2 under 25yoRisk of CIN3 progression is age-related

Age-specific incidence rates of cervical cancer

Incidence of cervical cancer

Age Group

New cases per 100,000

0-14 015-19 0.120-24 1.625-29 8.930-34 10.435-39 11.740-44 10.9

Age Group

New cases per 100,000

45-49 11.450-54 10.055-59 9.060-64 9.965-69 11.170-74 10.275-79 11.8

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 periodOther countries do not screen under age 25 yet have the same incidence and mortality for cervical cancerProtective effect of vaccination will reduce the benefits of screening in this age groupUnnecessary 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

What about the opportunistic screening?

Many GPs use pap smears for opportunistic screening of other health disorders and health counselling

Some use the speculum exam to also perform endocervical swabs for Chlamydia & Gonorrhoea

Opportunistic screening has not been factored in to the new cervical screening program

The screening interval is also designed to be ‘cost-effective’ with cost balanced with safety and effectiveness

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

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

Age-specific incidence rates of cervical cancer

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!)


Q8: Now, my feelings about the new Cervical Screening Program are:

1. Angry/annoyed

2. Worried

3. Neutral

4. It’s time for a change; I appreciate the need for a change

5. Excited

(mQlicker answers)


Q9: Now that I know about the changes to the Cervical Screening Program and the rationale behind it, I think:

1. We should stay with the current screening program

2. We should delay the release of the new program

3. We should change to the new program as announced

4. I still don’t know enough about the program to say either way

5. I don’t mind either way

(mQlicker answers)

CASE ONE

It is January 2017

20yo woman

Previously regular two-yearly pap smears – always normal

Last pap smear was two years ago

Asks what you recommend now that the screening age doesn’t start until 25yo

CASE ONE – mQlicker Question

SESSION KEY: 59596

What screening would you recommend?

1. No screening required at present

2. Pap smear

3. Pap smear AND HPV testing

4. HPV testing

5. Colposcopy

(mQlicker answers)

CASE TWO

It is January 2017

20yo woman

Never had a pap smear before

Asymptomatic

Asks what you recommend now that the screening age won’t start until 25yo

CASE TWO – mQlicker Question

SESSION KEY: 10886



2. Pap smear


4. HPV testing

5. Colposcopy

(mQlicker answers)

CASE THREE

It is April 2017

19yo woman

Persistent intermenstrual bleeding while on the COCP

Never had a pap smear

Asks what you recommend?

CASE THREE – mQlicker Question

SESSION KEY: 26985



2. Pap smear


4. HPV testing

5. Colposcopy

(mQlicker answers)

CASE FOUR

It is the present day (2015)

30yo woman

Just had a pap smear and it was negative

Asks when her next cervical screening will be..

CASE 4 – mQlicker Question

SESSION KEY: 27279

What screening would you recommend for her next cervical screening test?

1. Pap smear in 2017

2. Pap smear AND HPV testing in 2017

3. HPV testing in 2017

4. HPV testing in 2020 (five years from now)

(mQlicker answers)

CASE FIVE

It is August 2017

35yo woman

Just had HPV testing and it was negative

Married, monogamous relationship, “definitely no other partners involved”

“HPV is negative – I don’t feel I ever need any other HPV testing”


SESSION KEY: 98739


1. Agree that no screening required again as long as no new partners

2. Pap smear two-yearly

3. Pap smear AND HPV testing (any interval)

4. Still need five-yearly HPV testing

(mQlicker answers)

CASE 6

It is August 2017

71yo woman

Last had a pap smear 5 years ago – was told that she never needed another one again

Asymptomatic

Asks if she needs any cervical screening..


SESSION KEY: 34325


1. No screening required

2. Pap smear


4. HPV testing

5. Colposcopy

(mQlicker answers)

What is being done in the UK

Since Sept 2014, only 2 doses of HPV vaccine rather than 3

Since 2008, has been using LBC

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

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..

SummaryThe new cervical screening is coming in May 2017

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

MQlicker This session will utilise the mQlicker interactive audience program Questions will be presented and you will be able to respond electronically.

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