Primary HPV Screening It s screening Jim, but not as we know it. Adam Rosenthal PhD FRCOG Consultant Gynaecologist, Lead Colposcopist and HBPC

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1 Primary HPV Screening It s screening Jim, but not as we know it Adam Rosenthal PhD FRCOG Consultant Gynaecologist, Lead Colposcopist and HBPC

2 Dominique Jean Larrey (76 yr) Napoleon s chief battle surgeon Credited with developing modern battlefield surgery principles including triage 3 categories of wounded: 1. Survival inevitable 2. Death inevitable 3. Those in whom medical help may prevent death

3 Worldwide cervical cancer data (2012) Worldwide, more than 527,000 women were diagnosed with cervical cancer in 2012, with incidence rates varying across the world Worldwide, more than 265,000 women are estimated to have died from cervical cancer in 2012, with mortality rates varying across the world Source: CR UK

4 Worldwide Cervix Cancer Incidence Age standardised incidence per 100,000

5 Worldwide female cancer burden

6 UK Cervical cancer data (2014) 3,200 new cases/yr 890 deaths/yr 52% of cervical cancers diagnosed in women < 45 yr 13th most common cancer in UK women 1 in 135 UK women will be diagnosed with cervical cancer in their lifetime UK mortality rate is ninth lowest in Europe Since early 1970s, Cx cancer mortality rates have decreased by 72% Source: CR UK

7 HPV facts There are more than 100 types of HPV HPV is so common that 3 out of 4 people will have it at some point in their lives About 40 types of HPV can infect the anogenital area - vulva, vagina, cervix, rectum, anus, penis, and scrotum 17 high-risk HPV (HR-HPV) types present in high grade CIN and cervical cancers HR-HPV can be found in nearly 100% of all cervical cancers Low-risk HPV types found in warts/low grade CIN these do not cause cancer

8 One small jab - a giant leap for womankind Sydney Morning Herald, 2006 UK HPV vaccine coverage : National 83% vs. London 78% Beneficial impact in England not expected to be significant until 2020

9 Scottish vaccinated cohort: 50% reduction in CIN2 55% reduction in CIN3 Bivalent vaccine screening from age 20yr (<2016)

10 UK NHS Cervical Screening Program Arguably most successful cancer screening program worldwide ever Long duration of pre-malignant phase (CIN) CIN detectable via cervical cytology Call and recall system Tight quality control of every step of the process from smear taking to treatment and f/u of CIN Current major issue is falling uptake (London coverage just 66% in March 2017; 63% yr vs. 75% yr)

11 Screening - What we do now 24-50yr cervical cytology every 3 yr 50-64yr cervical cytology every 5 yr Normal continue as above Moderate/Severe (High grade) refer to colposcopy Borderline/Mild (Low grade) HPV-triage - negative routine screening - positive refer to colposcopy Test of cure 6/12 after treatment take smear and HPV both negative routine screening HG or HPV-positive colposcopy

12 UCLH Colposcopy Workload New referrals 1869 Follow-ups 1594 Total % of all referrals seen < 8/ % of all high-grade referrals seen < 4/52 Treatments 315 Negative cytology/negative HPV <1 yr after Rx 91%

13 How can we better identify the women with CIN? Primary testing for high-risk HPV to triage to cytology i.e. only use cytology in HR-HPV-positive women

14 Advantages of Primary HPV Screening Objective result from automated process cf. cytology Increased sensitivity for high grade CIN cf. cytology alone - lower false negative rate High negative predictive value - very unlikely to develop Cx cancer in 5 yr following neg HPV test Economies of scale for HPV testing Massively reduce number of cytology samples required in program

15 Primary HPV testing in England Pilot of primary HPV testing approved in England original pilot sites from HPV triage and test of cure enrolled Minority workload conversion in each site

16 1ry HPV Screening - What we will be doing: HR-HPV not detected return to routine screening HR-HPV detected, cytology positive: refer for colposcopy HR-HPV detected, cytology negative recall 12 months - persistent HPV 16/18, cytology negative colposcopy - persistent HR HPV non-16/18 positive 1 yr rpt if still positive refer Inadequate result: repeat in 3 months

17 Does it work?

18 15% of women tested were HPV-positive i.e. 85% reduction in cytology workload

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22 The challenges of Primary HPV screening

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24 Logistics Planned changeover to Primary HPV screening completed by December 2019-April 2020 Reduction in number of labs involved in cervical screening program to just in England (currently 10 in London alone) Commissioners will decide if one or two labs in London: Predicted 600,000 HPV tests and 90,000 cytology samples/yr (cf. >200,000 smears at HSL alone currently 36% of London s smears) Numbers likely to fall rapidly as vaccinated cohort continues to reach screening age

25 UK Age-Specific High-risk HPV Prevalence

26 Conclusions Challenges of introduction of 1ry HPV include: Advantages include: - Logistics of HPV testing (labs/personnel) - Increased colposcopy workload (initially) - Educating population about HPV - Reversing current trend of reduced screening uptake - Highly automated process - Increased sensitivity for high-grade lesions - Reduced inadequate smear rate - Longer protection from a negative result (may facilitate increased screening interval)

27 Acknowledgements Maggie Morgan for HSL facts Tanya Levene for NPH data Thanks Colp nurses: Linda, Victoria, Rachel, Dinah, Helen Colp docs: Tim, Adeola, Sarah and Kostas Colp HCAs: Leilani, Anna, Karen Colp admin: Jaleesa Funmi and the Level-1 reception team Nafisa Wilkinson and the UCLH gynae histopathology team Mary Falzon, Maggie Morgan, Lia Mylona and the HSL cytology team Primary care for doing the screening!

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