Future Directions for HPV and Cervical Screening. Jane Grant Metro Auckland Cervical Screening Forum June 2017

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1 Future Directions for HPV and Cervical Screening Jane Grant Metro Auckland Cervical Screening Forum June 2017

2 HPV Primary Screening HPV Self Sampling Research Source: Cervical Cancer : Symptoms, Stages and Treatment

3 70% Cervical cancer caused by HPV16 and HPV 18 rest add up to 99% Source: Seegene

4 How cervical cancer develops

5 National Cervical Screening Women years Programme Set up in 1990 after Cartwright Report One of the most successful programmes in the world Currently outside of WHO recommendations as evidence around screening and HPV has progressed.

6 History of Cervical Screening in New Zealand Trials carried out in Thames and Wanganui Guidelines on the frequency of tests smear tests became available published Cancer Society began pilot screening in Waikato and Otago The Skegg report recommends routine screening The Cartwright Report recommends a National Screening Programme The NCSP becomes fully operational National Database established The NSU established A team for NCSP established in the NSU Gisborne Cervical Screening Inquiry Dr McGoogan reports to minister on GCSI and adds further recommendations An amendment to the Health Act is passed

7 Reducing the incidence and mortality of cervical cancer Age-standardised rate Incidence Mortality Year

8 HPV Conversations Unique opportunity in primary care to discuss future screening at vaccination and vaccination with cervical screening Mother/daughter discussions Family discussions Lets get talking about HPV 8

9 Impact of HPV vaccination on high-grade lesions?

10 Future directions 2018 Changing the primary laboratory test Potential to reduce the harms of screening and allows transient infections to clear on their own without triggering further investigations is the current screening test HPV Testing will be the screening test in the future

11 Why HPV primary screening? HPV immunisation is the primary strategy for preventing cervical cancer. HPV primary screening with reflex cytology is secondary preventative strategy. The anticipated benefits of adopting primary HPV screening include: Decrease in cervical cancer incidence and mortality. (12-16% reduction in cancer incidence and mortality). Better detection of risk of precancerous cervical cell changes Safe and less frequent screening (every five years rather than every three).

12 National Cervical Screening Programme HPV Testing Guidance REFLEX HPV TESTING HrHPV testing for women with low grade lesions (ASC-US/LSIL) Risk assessment for progression Aged 30 years or more and no abnormal smears in the last 5 years TEST OF CURE testing for women with histologically confirmed and treated CIN 2/3 within the last 3 years Colposcopy and cytology follow up within 9 months post treatment 12 months post treatment and HrHPV test Test Results TEST OF CURE If Refer back to Colposcopy irrespective of cytology result shows low grade changes (ASC-US/LSIL) HISTORICAL TESTING testing for women with previous high grade squamous abnormality (cytology or histology) with or without treatment more than 3 years ago Smear taker must request test with smear and test Low grade or high grade cytology result? reflex test Laborotory adds on test automatically Exclusions CSYN, HSYN, glandular abnormality Women with CIN2/3 and associated glandular abnormality DO NOT USE HPV testing Low grade cytology ASC-US/ LSIL High grade cytology ASC-H or greater TEST OF CURE Repeat cytology at 12 months 24 months post treatment cytology and HPV Test HISTORICAL TESTING 12 month repeat cytology and test Test Results hr HPV TEST OF CURE If Refer back to Colposcopy irrespective of cytology result Refer to colposcopy Any abnormalities (ie ASC-US or greater) negative Return to 3 yearly screening Test of Cure (TOC) pathway Low grade relflex testing pathway Key Historical Testing (HT) pathway Shared pathway (TOC and HT) Women with a history of high grade squamous changes must test negative for both and cytology for 2 consecutive annual tests to return to 3 yearly screening. If 2 consecutive annual combined negative cytology and HPV tests, then return to 3 yearly screening Continue annual screening; consider referral to colposcopy (use clinical judgement any doubt refer to colposcopy) Low grade or high grade cytology result? Low grade cytology ASC-US/ LSIL High grade cytology ASC-H or greater Continue with annual testing until 2 consecutive annual combined negative cytology and HPV tests Refer to colposcopy

13 Moving to HPV primary screening in NZ WHO recommends primary screening and many countries are implementing HPV primary screening programmes A woman still needs to have a smear Less frequent screening: every 5 years instead of 3 Possible age range Possibility of self-sampling for some women, could reduce barriers to accessing screening

14

15 Potential benefits of HPV primary screening: Fewer cervical cancer cases and deaths Fewer smears throughout a woman s life Better detection of risk of precancerous cervical cell changes Effective for HPV vaccinated, and those who are not Test interpretation is less subjective Opportunity to consider HPV self-sampling for some women New Zealand programme remains consistent with internationally recognised best practice

16 Disadvantages Slightly lower specificity (ability to correctly identify women with no disease) Positive test does not necessarily mean clinically relevant disease HrHPV test less able to tell the difference between transient infection and infections that are related to CIN2+

17 Disadvantages The 30-40% more pickup using a primary HPV test (which will reduce the number of cancers/deaths) Would require investigation of many more women who turn out not to have disease Will increase the need for colposcopies

18 Proposed Changes to NCSP NSU Consultation document September 2016 Key changes: Changes to screening age Screening interval changes from 3 to 5 years Primary test will change from LBC to HPV Partial genotyping for 16 & 18 LBC for all positive samples

19 Women under 25? Rates of cancer for this group have not reduced since screening Early treatment of high grade lesions associated with: Pre-term delivery Low birthweight Increased perinatal morbidity BMJ: Perinatal mortality and other severe adverse pregnancy outcomes associated with treatment of cervical intraepithelial neoplasia: meta-analysis Arbyn et al

20 Testing and Screening for those with increased risk Selective co-testing will be used for women who: - have symptoms suspicious of invasive cancer - have a positive screening test (any HPV subtype) - have been treated for a high-grade lesion (test of cure) - are at greater clinical risk (e.g. immunosuppressed) this is investigation of increased individual risk, not population-based screening of asymptomatic women

21 HRC: HPV Self sampling study Wellington and ADHB/WDHB 6000 priority group women 3 arms at clinic mail out usual care Purpose to inform policy Low vaginal self taken swab similar to PCR swabs used to screen for chlamydia All positive results will require LBC and/or Colposcopy

22 HPV Workforce Survey Massey University research Aims to inform NCSP on health professional knowledge Aims to inform NCSP on general public knowledge of HPV

23 Self-Sampling only available as part of research

24 Future Directions HPV self sampling? Will priority group women change? Development of future vaccines Future screening for other cancers?

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