precision medicine in lmic: euromed network. · ott-dic 2014 colorectal jan-dic 2013 colorectal...
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Precision Medicine in LMIC:
EUROMED Network.Il caso dello screening del cancro della cervice
uterina
Nereo Segnan
CPO Piemonte
WHO CC Early Diagnosis and Cancer Screening
Primo Summit Mediterraneo Sanità
Napoli, 11-12 febbraio 2016
The Euro-
Mediterranean Cancer
Network for Women
A proposal to develop women’s empowerment in
the field of health promotion and cancer screening
Euromed Cancer Network
Participating countries and parties: Albania, Algeria, Bosnia and Herzegovina,
Egypt, Jordan, UN interim Administration of Kosovo, Lebanon, Montenegro,
Morocco, West Bank and Gaza, Serbia, Syria, Tunisia and Turkey.
Organisations and institutions: WHO, Italian Ministry of Health, The National
Cancer Institute of France (INCa), the Catalan Institute of Oncology (ICO), the
International Agency for Research on Cancer (IARC), the United Nations
Population Fund (UNFPA), the Association of European Cancer Leagues (ECL),
the European Network of Cancer Registries (ENCR), and the International
Association of Cancer Registries (IACR).
Albania Morocco West Bank
and Gaza
breast Jan-Dic 2013 breast Jan-Dic 2013 breast Jan-Dic 2013
cervical Jan-Dic 2013 cervical Jan-Dic 2013
colorectal Jan-Dic 2014
Jordan Serbia Turkey
breast Jan-Dic 2013 breast Jan-Dic 2013 breast Jan-Dic 2013
Lebanon cervical Jan-Dic 2013 cervical Jan-Dic 2013
breast Ott-Dic 2013
Ott-Dic 2014
colorectal Jan-Dic 2013 colorectal Jan-Dic 2013
Montenegro Tunisia
colorectal Jun 2013-Jun
2014
breast 2013-2014
Programmi attivi nei paesi che hanno risposto al questionario
Oltre all’Albania, il Marocco, la Serbia e la Turchia, il Montenegro avvierà un
programma sulla cervice entro la fine del 2016 utilizzando come test di
screening l’HPV.
EUROMED UFM
project (with Italian MoH, WHO support)
1° phase
• Context analysis
2° phase
• Pilots projects• Cervical cancer screening
HPV + lab.
• Breast cancer screening BCE
1st Phase
Context analysisa) Infrastructures (presence and conditions)
b) Cancer-related health statistics
c) Human/instrumental resources
d) Professional education and training needs
e) Data management and analysis needs
f) Breast and cervical cancer diagnosis/care pathways
g) Breast and cervical cancer treatment resources (colposcopy , gynaecology, oncology , radiotherapy and chemotherapy )
e) Barriers and facilitators related to breast/cervical cancer screening implementation
2nd Phase Piloting: Albania, Montenegro, Morocco
Two scenarios:• Cervical cancer screening HPV + lab.
• Breast cancer screening BCE
In both cases:
– Identification of area/areas where to run the pilot projects.
– Establishment of networking tools (website dedicated blogs, etc.) for the sharing and exchange of opinions , instruments, documents and products
– training
– Preparation and activation of the pilot
– Monitoring and evaluation
Lo screening del tumore del collo dell’utero
(cervice) mira a individuare e trattare le lesioni
preinvasive, prevenendo così i tumori invasivi.
I papillomavirus umani HPV sono considerati causa
necessaria del carcinoma della cervice uterina.
WHO guidelines (2013)
Procedura invasiva che comporta un alto rischio di effetti negativi
sull’apparato riproduttivo
Screening cervicale nei Paesi a basso/medio reddito:
situazione attuale
•In contesti elitari: screening combinato → esame
citologico (Papanicolaou test o Pap test) + test del DNA per la
ricerca dei ceppi oncogeni del Papillomavirus umano (test HPV-
DNA)
La combinazione dei due test non aumenta la protezione, mentre
può portare a un eccesso di sovradiagnosi e sovratrattamento
Cosa sappiamo• è più sensibile della citologia per le HGCIN.
•Lo screening basato sull test HPV-DNA permette
di individuare precocemente HGCIN che la
citologia avrebbe individuato più tardi
• lo screening basato sul test HPV-DNA previene
più cancri rispetto alo screening basato sulla
citologia (rischio di cancro ridotto del 60/70%)
Cosa sappiamo
• Il periodo di basso rischio per HGCIN e per cancro
invasivo dopo un test HPV-DNA negativo è più lungo che
per una citologia normale (ciò consente un allungamento
dell’intervallo di screening)
• È necessario un triage per le donne positve al’HPV
Risk of invasive carcinoma after a negative entry test
(HPV- in HPV arm and cytology- in cytology arm)
3.5 years 5.5 years
cytology 15.4 (CI 7.9-27.0) 36.0 (23.2-53.5)
HPV 4.6 (1.1-12.1) 8.7 (3.3-18.6)
observations censored 2.5 yrs after CIN2
or CIN3 detection, if any
Solid lines: HPV
group.
Dotted lines:
cytology group
Pooled RR
0.30 (0.15-0.60)
Ronco et al. Lancet 2014 modif.
Supplements to EU guidelines for quality
assurance in cervical cancer screening Eds: A.Anttila, M.Arbyn, H.De Vuyst, J.Dillner, L.Dillner, S.Franceschi,
J.Patnick, G.Ronco, N.Segnan, E.Suonio, S.Tornberg, L.von Karsa
• S1 Screening for cervical cancer with primary testing for
human papillomavirus
– G.Ronco, M.Arbyn, CJLM Meijer, PJF Snijders, J. Cuzick
• S2 Organisation of cytology-based and HPV-based cervical
cancer screening
– A.Anttila, G.Ronco, F.Nicula, P.Nieminen, M.Primic Zakelj
• S3 Implementation of vaccination against human
papillomavirus in Europe.
– H.DeVuyst, R Howell-Jones, D. Levy-Bruhl,P.Giorgi Rossi,
S.Franceschi
Guidelines can be downloaded at:http://bookshop.europa.eu/en/european-guidelines-for-quality-assurance
-in-cervical-cancer-screening-pbEW0115451/?AllPersonalAuthorNames=true
Screening cervicale costi
Ronco G, et al. Ricerca del DNA di papillomavirus umano (HPV) come test
primario per lo screening dei precursori del cancro del collo uterino. HTA Report.
Epidemiol Prev 2012; 36 (3-4) suppl 1: e1-72
Screening cervicale nei Paesi a basso/medio reddito:
potenzialità
Lo screening basato sul test HPV permette di superare le difficoltà
relative alla necessità di personale altamente qualificato che si
presentano nello screening citologico. Inoltre, se si ricorre a strategie
di telemedicina, è potenzialmente sostenibile in contesti a basso-
medio reddito
Anno di implementazione ed estensione geografica
Albania Morocco West Bank
and Gaza
breast OPP 2011 N breast ORG 2010 N breastORG /
OPP2011 CA
cervical OPP 2011 CA cervical ORG 2010 CA
colorectal OPP
ORG2014 N
Jordan Serbia Turkey
breast OPP 2007 N breast ORG 2012 CA breast ORG 2004 N
Lebanon cervicalORG
OPP2012 CA cervical ORG 2004 N
breast OPP 2004 N colorectal ORG 2012 CA colorectal ORG 2012 N
Montenegro Tunisia
colorectal OPP
ORG2013 N breast OPP 2000 N
OPP: opportunistic
ORG: organizedN: national
CA: certain areas
Età, test utilizzati, intervallo ed esami diagnostici
screening test interval diagnostic test
age VIA Pap LBC HPV VIA-I HPV Colp. Biopsy
Albania
Morocco 30-49
3
Serbia 25-64
3
Turkey 30-65
5
VIA: Visual Inspection with Acetic Acid
Pap: Pap smear
LBC: Liquid-based cytology
HPV: HPV DNA test
VIA-I: Visual inspection with Lugol
(Schiller test)
Colp.: Colposcopy
Copertura e partecipazione
pop. size invited tested test + cancer
Albania
Morocco 1 708 569 53 476 (3,0%) 5 373 (10,0%) 3 528
(65,7%)
86 (16,0‰)
Serbia 169 883 99 875 (58,8%) 6 342 (6,3%) 45 (0,5‰)
Turkey 16 045 550 3 209 110 (20%) 2 450 019 (76,3%)
• Stand-alone HPV as primary (organised programmes)
• Start HPV at 30-35 years
• Stop as with cytology
• 5-year interval
• Cytological triage of HPV+ women
• Validated tests
• Self sampling just for non responders
Screening cervicale nei Paesi a basso/medio reddito:
situazione attuale
•Test di screening utilizzato prevalentemente: Visual
Inspection with Acetic Acid (VIA): inserimento di uno
speculum vaginale e tamponamento della cervice con soluzione al
3% al 5% di acido acetico, per poi procedere a un’ispezione della
cervice. Le lesioni CIN diventano bianche un paio di minuti dopo l'applicazione di acido acetico.
Perspectives
• LMIC new technologies: cervical cancer screening in
the lab (HPV + biomarker triage), clinics only for
treatment
• Implement primary prevention and screening with pilot
projects
• Screening and vaccines
• Mitigate overdiagnosis and control overtreament
• Consortium of research on cancer screening and natural
history research
• review and evaluation of screening scientific evidence as
basis for screening policies and guidelines