Swiss Federal Office of Public Health
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1 SGPath - Bern May 9, 2015 CIN3+ Study of the Swiss Federal Office of Public Health Joachim Diebold Luzerner Kantonsspital Pathologisches Institut
2 HPV - vaccination: Australia as good example Anderson LA Pathology 44:1-6 (2012) 2007: first country with national HPV vaccination program girls years 50-80% of girls in schools are vaccinated (Aim: vaccination coverage of 80%) First results: reduction of CIN2-3 in Pap smears of women younger than 18y from 0,8% to 0,42% Long term projection: until 2050 reduction of HPV16 infektions by 83% in women Estimated effect, if men are included: 88-94% reduction of HPV16 in women, 68-82% reduction of HPV16 in men, 22-27% decline HPV-related cancer in men
3 Carcinoma of Cervix uteri Switzerland: around 240 new cases and 90 deaths per year
4 CIN3/Carcinoma in situ Switzerland: around 1500 new cases per year >> conisations Late sequelae: premature births, birth complications
5 Projection of the Swiss Federal Office of Public Health 5
6 CIN3+ study: Background HPV vaccination in CH since 2008 costs are covered by basic Swiss health insurance (OKP) vaccines are directed against HPV types 16,18, 6,11 (Merck company) and 16,18 (GlaxoSmithKline company) large variation of HPV vaccination coverage within and between cantons 6
7 HPV vaccination in cantone Lucerne secondary schools professional schools
8 HPV vaccination in Switzerland ( ) (Percentage of 16 year old females who received 3 doses of vaccine) average: 51% 63% 59% 71% 66% 52% 64% 53% 37% 59% 40% 44% 17% 50% 27% 61% 47% 31% 40% 35% 24% 59% 44% < 30 % % % > 70 % 62% 75% 38% Cancer registration in Switzerland BAG Durchimpfung OFSP: couverture vaccinale
9 CIN3+ study: Starting point Does HPV vaccination lead to a reduction of HPV related lesions, morbidity and deaths in Switzerland? Does HPV vaccination result in redistribution of causative virus types in these lesions? These questions can only be answered by a monitoring system. Ultimate goal: Establish a system for future impact monitoring of HPV vaccination 9
10 CIN3+ study: Stake holders Government: Swiss Federal Office of Public Health Epidemiology: Institute of Social & Preventive Medicine (ISPM), University of Berne Cancer Registration: National Institute for Cancer Epidemiology and Registration (NICER), Cantonal Registries Pathology/Cytology: Swiss Society of Pathology (SGPath) Virology/Laboratory medicine: CHUV Institut de Microbiologie (member of the group of WHO virology reference labs for HPV) Gynaecology: Swiss Society of Obstetrics and Gynaecology (SGGG) 10
11 CIN3+ Study Outline duration 2 years ( ) selection of an epidemiologically representative cohort of patients with well defined HPV-associated lesions CIN3 adenocarcinoma in situ (AIS) invasive cervical carcinomas (squamous carcinomas and adenocarcinomas) 700 samples prospectively HPV tests on FFPE specimens Questionnaires for patients 200 retrospective samples (2014) HPV tests on FFPE specimens 11
12 CIN3+ Study: Rational for case selection Robust inclusion criteria were needed > Morphology Ideally only invasive carcinomas, however number is too small Regarding pre-invasive lesions, inclusion of all CINs diagnosed either by cytology or histology would make the case load too large Reasonable compromise: histologically proven CIN3 / Carcinoma in situ and invasive carcinomas Therefore pathology institutes came into center stage. Additional argument: These lesions are traditionally documented by Swiss cancer registries > reliable epidemiological data base 12
13 Pathology institutes involved 10 institutes in 6 cantons with established cancer registries representing all language regions of Switzerland Kantonsspital Luzern (Luzern) Kantonsspital Baselland (Baselland) HUG (Genève) Universitätsspital Basel (Basel) Universitätsspital Zürich (Zürich) Medica (Zürich) Instituto cantonale di patologia (Ticino) Viollier Weintraub SA (Genève) Cancer registration in Switzerland Institut Pathologie Enge (Zürich) Viollier AG (Baselland) 13
14 Quality assurance of HPV testing Participation in two robin round tests mandatory Virology: spectrum of high risk HPV types 46 samples viral DNA in pre-defined concentration organized by WHO (Equalis Uppsala) Pathology: formalin-fixed, paraffin-embedded samples 8 samples organized by QuIP (Provitro Berlin)
15 Recent change in terminology LAST Empfehlungen International Journal of Gynecological Pathology 2012; 32: tiered terminology (traditional 3-tiered -IN terminology 2014 can be added optionally) Low grade squamous intraepithelial lesion (LSIL) versus high grade squamous intraepithelial lesion (HSIL) Uniform terminology for all HPV-associated pre-invasive squamous lesions of the ano-genital region cervix: CIN, vagina = VaIN, vulva = VIN, anus = AIN, perianus = PAIN, penis = PeIN
16 Importance of p16 immunhistochemistry The Lower Anogenital Squamous Terminology Standardization Project for HPV-associated lesions Darragh et al. The CAP-ASCCP LAST Project IntJGynPathol 2012; 32:76-115
17 CIN1 (LSIL) CIN 3 (HSIL) p16 CIN 1 LSIL HSIL p16 CIN 2-3
18 CIN 2 (HSIL) HSIL p16 CIN 2
19 Recent change in terminology - relevance for CIN3+ study Why not change the inclusion criteria from CIN3 to HSIL? Simply, because CIN3+ study had already started. Terminology change probably would have no effect on HPV test results. However, the number of cases would increase, because CIN2 cases (p16 positive ones) would be included. Future HPV monitoring system should be based on WHO 2014 terminology. 19
20 CIN3+ study: Summary CIN3+ study started in January Results can be expected earliest for 2017: HPV type distribution in CIN3, AIS, invasive cervical carcinomas in Swiss patients Correlation with epidemiological data (cases from ) Feasibility of a system for future impact monitoring of HPV vaccination - Sample size - Number of sentinel pathology sites - Time frame 20
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