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Epidemiology of cervical cancer

Introducing the National Cervical Screening Program: providing your patients the right advice November 2017 Dr Hilary Bower Medical Coordinator Family Planning NSW.

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Epidemiology of cervical cancer

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  1. Introducing the National Cervical Screening Program: providing your patients the right advice November 2017Dr Hilary BowerMedical Coordinator Family Planning NSW

  2. Aims of this sessionTo understand the National Cervical Screening Program: implementation on December 1st 2017How to explain the National Cervical Screening Program to patients?How to access supporting resources?

  3. Epidemiology of cervical cancer • Cervical cancer is the 15th most commonly diagnosed cancer in Australian women, accounting for 1.5% of cancers in Australian women • Since 1991, 50% decrease in mortality due to cervical cancer, largely due to our NCSP: a public health success story! • 80% of women with cervical cancer had not had a Pap smear in the previous 5 years • Australian Institute of Health and Welfare. Cervical Screening in Australia • 2013-14. Canberra: AIHW 2016. Cancer Series no.97 Cat. no. CAN 95. • Australian Institute of Health and Welfare. Cancer in Australia • 2017. Cancer series no.101. Cat. no. CAN 100. Canberra: AIHW

  4. Time for a change….. Timely for Australia to take a lead with an evidence-based program based on: new understanding of HPV & cancer new testing technologies a successful National HPV vaccination program

  5. HPV: the ‘common cold’ of the genitals! • Up to 80% of people infected in their lifetime; usually resolves within 1 - 2 years •  > 99% cervical cancer linked to oncogenic HPV subtypes • 14 oncogenic HPV types (16 & 18 more likely to persist detected in 70%–80% cases cervical cancer) • Penetrative intercourse not strictly necessary; HPV can be transferred to the cervix from an infection at the introitus • Transmission via genital skin-to-skin contact, vaginal sex, oral sex & anal sex • Introduction of the Gardasil-9 in 2018!

  6. The link between HPV infection and cervical cancer 2% of persistent oncogenic infections associated with cancer; takes about 10 years to develop CIN 3: up to a 1/3 will progress to invasive cancer within 10–20 years

  7. National Cervical Screening Program from 1st December 2017 ensuring all women (vaccinated and unvaccinated) have access to a program that is acceptable, effective and efficient and based on current evidenceAim for up to 36 % fewer cervical cancers www.msac.gov.au

  8. Understanding the new National Cervical Screening Program All women who have ever been sexually active will be invited for Cervical Screening Test at 25 years Women will be managed using a risk-based approach that is dependent on the cervical screening test results Cervical screening may cease between 70 and 74 if regular screening tests with –ve results and a –ve exit result Routine screening carried out every 5 years for women with no symptoms or history suggestive of cervical cancer Invitations and reminders will be sent by the National Register to screen-eligible women

  9. What is the Cervical Screening Test? The Cervical Screening Test has 2 components: 1. HPV DNA test with partial genotyping (to allow independent detection and reporting of HPV 16 and 18; other oncogenic HPV types are reported as a pooled result) 2. Reflex liquid based cytology (LBC) if the HPV test is +ve for any oncogenic HPV type (performed automatically on the same sample); results of LBC used to inform colposcopy

  10. Your essential guide…. “National Cervical Screening Program: Guidelines for the Management of Screen Detected Abnormalities, Screening in Specific Populations and Investigation of Abnormal Vaginal Bleeding.” http://wiki.cancer.org.au/australia/Guidelines:Cervical_cancer/Screening

  11. Why is primary HPV testing replacing the Pap test? A significant false-negative rate for Pap vs HPV tests (30% vs 2-3%) required more frequent screening to minimise failure to detect disease Women who test HPV -ve are at very low risk of HSIL and cancer for at least 5 years Compared with cytology, HPV testing provides 60–70% greater protection against invasive cervical cancers; significantly reduced incidence of adenocarcinomas Opportunity for self collection in under-screened populations Renshaw AA et al. Cancer Cytopathology 2001;93:106-10Dr Guglielmo Ronco et al. Lancet 2014;383:524-32

  12. Why use partial genotyping? Partial genotyping allows for separate detection of HPV 16 and 18; other oncogenic HPV types will be reported as a pooled result HPV 16 and 18 are associated with cervical abnormalities that are less likely to regress and more likely to progress to high-grade cervical abnormalities, compared with other oncogenic HPV genotypes Improves risk stratification/assessment in the screening program Castle PE et al. ObstetGynecol 2009;113:18-25; Kjaer SK, et al. J Natl Cancer Inst 2010;102:1478-88; Schiffman M, et al. Cancer Epidemiol Biomarkers Prev 2011;20:1398-409

  13. Explaining changes to the screening age:routine screening not recommended < 25 Cervical cancer very rare in young women Screening < 25 years has not reduced invasive cancer rates or deaths in this age group or in 25-29 year olds HPV vaccination already showing a reduction in screen-detected abnormalities in women <25 years of age Cervical abnormalities common < 25 years and usually resolve; over-diagnosis and over-treatment not desirable History of childhood sexual abuse or early sexual debut (< 14 years, prior to HPV vaccination): consider a HPV test between 20—24 years Symptomatic women of ANY age should be assessed with a co-test Peirson L et al Syst Rev 2013;2:35; KyrgiouM,et al Lancet 2006;367:489-98; Sasieni et al BMJ 2009; Schlect NF J Natl Cancer Inst 2003;95:1336-43

  14. A co-test is different to a Cervical Screening Test! A co-test is when a sample is tested for HPV DNA and cytology at the same time Not part of routine screening & must be specifically requested on the pathology request form: • at follow up of certain abnormalities eg glandular abnormalities after normal colposcopy • as part of Test of Cure (after treated CIN2/3) • for some women post hysterectomy • for DES-exposed women • for women treated for adenocarcinoma in situ (AIS) • as part of Ix of abnormal vaginal bleeding or an abnormal looking cervix

  15. What will change in clinical practice? • Discuss changes to the screening program for asymptomatic women • Transition clients to the new program • Collect the Cervical Screening Test using a liquid based medium (slides no longer used) • Order a CST on the pathology request form (or a co-test if indicated) Discuss results and risk assessment • Use the new management guidelines • Inform clients about the National Cancer Screening Register

  16. The cervical screening pathway for asymptomatic women under National Cervical Screening Program (NCSP)from December 1st 2017

  17. What should you expect from a lab report? results are stratified by risk An overall cervical screening risk assessment: • Low risk – oncogenic HPV negative • Intermediate risk - e.g. HPV detected (not 16/18 and LBC negative or LSIL ) • Higher risk - e.g. HPV detected (16/18) A statement of test(s) performed and results: • HPV test result including LBC result (if performed) A recommendation for follow up: • taking account of result, screening history and clinical notes

  18. Sara is +ve for HPV 16:what do you do? • Sara’s result is higher risk • referral to colposcopy regardless of LBC result • If LBC is unsatisfactory, repeat LBC at time of colposcopy • If LBC result predicts invasive disease referral within 2/52 • If LBC result PHSIL/HSIL referral within 8/52

  19. Sara is +ve for HPV (non 16/18):what do you do? Reflex LBC Unsatisfactory PHSIL/HSIL or any glandular Invasive disease Normal or LSIL/PLSIL Rpt LBC 6-12/52 Rpt HPV 12/12 Colposcopywithin 8/52 Colposcopy within 2/52 +ve HPV(any type)-colposcopy -ve HPV Retest 5 years

  20. Sara has a glandular abnormality? All glandular abnormalities refer to an expert gynaecologist for colposcopy including “Atypical endocervical/glandular cells of undetermined significance” Follow up of completely excised AIS: • annual co testing indefinitely • any abnormal result refer for a colposcopy

  21. Unsatisfactory results: the Cervical Screening Test cannot be evaluated ‘unsatisfactory HPV’ or ‘unsatisfactory LBC’ test report unsatisfactory HPV: test cannot be performed due to inhibition (e.g. too much blood) or insufficient human DNA in sample unsatisfactory LBC: insufficient cells or technical problems such as excess blood or lubricant advise a repeat sample 6-12 weeks later after rectifying the reason (refer straight for colposcopy if unsatisfactory LBC and +ve HPV 16 or 18)

  22. Maximising sample quality Ensure adequate transfer of cellular material from the implements to the liquid medium Use warm water rather than commercial lubricants to avoid cell agglutination and cellular loss (if used: avoid carbomer and carbopol polymer lubricants; use sparingly and avoid speculum tip) Defer routine screening during menstruation but don’t delay diagnostic co-testing for abnormal vaginal bleeding Avoid intravaginal medication for 48hrs prior to testing

  23. Self-collection of a vaginal HPV test http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/resources-menu

  24. Self-collection of a vaginal HPV sample • Alternative for eligible under or never-screened women who have declined invitations to participate in conventional screening Eligibility: • 30 years + and never had cervical screening • 30 years + and overdue by 2 years  or longer • Facilitated by a health professional within a healthcare clinic • Dry flocked swab self-inserted into vagina

  25. Self-collection of a vaginal HPV sample Lower sensitivity and specificity than a clinician-collected HPV sample (pooled sensitivity and specificity ratios of 0.88 (0.85-0.91) and 0.96 (0.93-0.99) respectively for CIN 2 or worse Cannot perform reflex LBC; if HPV 16 or 18 detected refer directly for colposcopy; other oncogenic HPV requires examination and clinician sample for LBC) Arbyn M et al. Lancet Oncol 2014; 15: 172-83

  26. Transition into the National Cervical Screening Program Women aged 25 to 74 will be invited for a Cervical Screening Test two years after their last Pap test (new migrants & refugees) Women already screened under 25 will be a sent a letter advising rescreening at age 25; an invitation letter (and reminders) will be sent from the NCSR at age 24 and 9m Women overdue by 2 years of more and >30 years old will be invited to screen and self collection an option. Women under surveillance for an abnormal Pap test: follow guidelines Provide cytology screening if due until Dec 1st!

  27. Screening for specific populations: Pregnancy & Postpartum Post-menopause Early sexual activity Immune-compromise (screen every 3 years) Post-hysterectomy DES-exposure in utero Transgender men with a cervix (consider a short course of vaginal oestrogen) Women with abnormal vaginal bleeding or an abnormal appearing cervix

  28. Screening for specific populations • Pregnancy – perform if due (use a broom-type sampler brush NOT a cytobrush or combi-brush) • Self-collection not recommended • Postpartum - screen > 6 weeks after delivery; if breastfeeding or no menses, consider prior short course vaginal oestrogen • Post-menopausal – no recommendation for routine vaginal oestrogen; consider if vaginal dryness/superficial dyspareunia or if reflex LBC unsatisfactory due to atrophy, insufficient cells or inflammation or prior to colposcopy

  29. Screening in specific populations:immunocompromised Immune-deficiency - HIV +ve or solid organ transplant recipients screen 3 yearly if normal screening history Consider 3 yearly screening in other immune-deficient women: • congenital primary immune deficiency • immunosuppressant therapy • bone marrow transplant recipients • screening young women(20-24 years) if immune deficient for more than 5 years. +ve HPV (any type) referral for colposcopy (with experienced gynaecologist) regardless of LBC result. . ))

  30. Screening in specific populations: Diethylstilboestrol (DES) exposure Women exposed to DES in utero: should be offered an annual co-test (HPV + LBC) and expert colposcopy and examination of the cervix and vagina indefinitely. Not for self collection No evidence of increased risk for ‘DES granddaughters’- routine screening recommended ( 5 yearly HPV testing) 1Pharmaceuticals WHO 2012

  31. Investigation of women with abnormal vaginal bleeding

  32. Abnormal vaginal bleeding (post-coital,intermenstrual, postmenopausal) Malignancy uncommon but must be excluded; consider pregnancy, STIs, polyps, coagulopathies, ovulatory disorders, endometrial disorders, vaginal atrophy, hormonal contraception Women of ANY age with signs or symptoms suggestive of cervical cancer should have a co-test Co-test: a HPV DNA test AND liquid based cytology on the same sample Co-test has high negative predictive value for HSIL/CIN3 Do not delay co-test due to the presence of blood: co-testing improves reduced sensitivity of individual tests Management of co-test results……..

  33. Investigation of women with abnormal vaginal bleeding

  34. Management after treatment: Test of Cure Gynaecological review at 4-6months post treatment CIN2/3 Subsequent surveillance is called a ‘Test of Cure’; usually performed in primary care: • co-test(HPV and LBC) at 12 m and annually thereafter until all components negative on 2 consecutive occasions At anytime during Test of Cure: • +HPV 16/18 or • LBC PHSIL/HSIL colposcopy • any glandular lesion

  35. Some groups are more likely to be under or never-screened • Aboriginal and Torres Strait Islander • Culturally & Linguistically Diverse ( CALD) • History of sexual trauma and/or domestic violence • Living in a rural or remote areas, • Identify as lesbian, bisexual, or same sex attracted • Transgender men (with a cervix) • Older women • Women with disabilities (intellectual or physical) • Women from lower socioeconomic status • Women who have received the HPV vaccine

  36. How to improve screening uptake? • Cultural awareness-including language barriers • Provide educational leaflets and posters • Stress importance of cervical screening as a preventative measure - prevents cancer • Asking if prefer to see a female colleague • Consider self-collection for eligible women

  37. Understanding the National Cancer Screening Register • Single record for cervical & bowel cancer screening; will be linked to HPV vaccine registry • Records screening & colposcopy data; provides screening Hx to labs to inform recommendations • Health Care Provider portal • Consumer portal: limited information e.g. check due date for test or change address. • Sends letters of invitation and reminders; women can opt for reminders by mail, email or SMS; can nominate a personal representative • Women can ‘opt off’ by contacting the NCSR (initially by phone with or without support from clinician); previously via pathology request form and lab

  38. The cervical screening consultation:what’s new and what’s the same • Discussion about screening; history taking; informed consent • Addressing screening barriers and opportunistically screening • ExperienceIS THE SAME FOR THE PATIENT with speculum examination • Sample of cells from squamo-columnar junction; no slides! • Opportunity for self-collection for eligible under-screened women • Completion of pathology request form for Cervical Screening Test (history, symptoms, examination) • Lab performs HPV test +/- reflex LBC • For specific indications order a co-test on the form

  39. The cervical screening consultation:what’s new and what’s the same • Timely receipt of abnormal results; clear documentation of consultation and any follow-up • Discussion of results; risk assessment for cervical abnormality: • Low risk: invited to screen in 5 years • Intermediate risk: invited to screen in 12 m to check HPV clearance • Higher risk: referred for colposcopy • Using the new management guidelines • Informing women about the National Cancer Screening Register

  40. Resources for women and health professionals http://www.cancerscreening.gov.au/internet/screening/publishing.nsf/Content/resources-menu

  41. Resources for health professionals Clinical guidelines wiki.cancer.org.au/australia/Guidelines:Cervical_cancer/Screening Clinical guidelines - Short Form Summary http://wiki.cancer.org.au/australiawiki/images/2/2e/National_Cervical_Screening_Program_guidelines_short-form_PDF.pdf Clinical guidelines - Long Form Summary http://wiki.cancer.org.au/australiawiki/images/a/ad/National_Cervical_Screening_Program_guidelines_long-form_PDF.pdf

  42. Resources • Background information on the Renewal www.msac.gov.au • NPS MedicineWise Learning modules on the changes to the National Cervical Screening Programhttps://learn.nps.org.au/mod/page/view.php?id=7804 • National HPV Vaccination Program Register www.hpvregister.org.au • HPV vaccination www.cervicalcancervaccine.com.au

  43. FPNSW resources • Talkline: phone 1300 658 886 • Reproductive and Sexual Health: an Australian Clinical Practice Handbook 3rd edition • Fact Sheets: Cervical Screening and HPV vaccination https://www.fpnsw.org.au/health-information/individuals/pap-test-and-cervical-screening • Everything you need to know about the changes to NSCP https://www.fpnsw.org.au/changes

  44. Key messages • Encourage eligible women (vaccinated and unvaccinated) to attend for cervical screening; opportunistically screen • New National Cervical Screening Program starts 1st December; evidence-based tests and protocols • ‘More accurate and less harm’ • The Cervical Screening Test replaces the Pap test on 1st December 2017 - no more slides! • Encourage primary prevention with HPV vaccination • Know where to go for information (including for specific populations)

  45. Thank you and any questions?

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