Implementering af det nationale mammografiscreeningsprogram i Danmark

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1 Implementering af det nationale mammografiscreeningsprogram i Danmark DRS Årsmøde Januar 2014 Ilse Vejborg Klinik- og screeningschef, RH

2 Mammography Screening in Denmark Denmark - is one of the European countries with high risk of breast cancer - has one of the highest age standardized breast cancer mortality rates in the world - has the highest mortality rate in the Nordic Countries - breast cancer is the most frequent cancer in Denmark - is one of the countries in the world who have had the most heated debate about pros and cons of mammography screening - offers an unique opportunity to do research on impact of mammography screening

3 Populationbased, organized Mammography Screening Each women is identified by a unique ID in a population register Personal invitations 2 standardised x-ray examinations of each breast every second year Questioner No clinical examination No contact with a physician No ultrasound examination CC MLO A fast (6-10 minutes) and inexpensive examination which can be performed anywhere in the regions independent of the physicians presence. Highly skilled physicians trained in evaluation of screening mammograms and highly skilled radiographers making the mammograms are necessary!

4 Mammography Screening in Denmark /1994 Organised mammography screening were offered free of charge to women aged years every second year in 4 out of 16 regions. The programmes covered around 20 % of the target population Opportunistic screening is very limited. Only 3 % Q aged years had a mammogram in non screening areas in 2000

5 Mammography Screening in Denmark /

6 Organisation and Results Reduction in breast cancer mortality is the final criterion of success but you have to wait at least 8 to 10 years before mortality data is available In the mean time detailed recording of data to monitor process and impact is necessary IV

7 Mammography Screening in Denmark Important Quality Indicators Participation rate (population level) Detection rate, especially of small cancers 1cm ( women's level) False positive rate Benign/malignant operation ratio False negative rate

8 Participation rate in the biennial mammography screening in Copenhagen municipality Number in Participants in percent of Invitation Target Target Invited Regularly Round Population Population Women Screened % 71% 71% % 69% 83% % 70% 90% % 70% 91% %-77% Fyn % - 84% (of target) EU-guidelines: >70% / >75% ( acceptable /desirable) I Vejborg et al ; J Med Screen: 2002 ; 9 : Sisse Njor et al, APMIS ; 2003 : vol. 111:1-33

9 Detection rates of invasive breast cancers or DCIS in the biennial mammography screening in Copenhagen municipality Detected cases per 1000 participants. Invitation Screen number Round Total Total Per cent DCIS Year ,9% (IC+DCIS) I Vejborg et al ; J Med Screen ; 2002 : 9:115-9 Fyn: 1,0% ( 1.invitation round) 0,5% (subsequent rounds) Sisse Njor et al: APMIS; 2003:vol.111: 1-33

10 Invasive Breast Cancers in Denmark Tumour size All women ( whether screened or not) aged Copenhagen Fyn West Zealand Rest of Denmark < 20mm 69% 69% 52% 50% 10mm 25% 23% 13% 10% 20mm 31% 31 % 48% 50% Source: DBCG. Personel communication

11 Breast Cancer Mortality in Copenhagen after 10 years of Mammography Screening ( ) Women invited for screening Before screening During screening 25% reduction Copenhagen RR 1,22 Historical regional control group Study group RR: 0,91 Women participating in screening Rest of Denmark with out screening Historical control group Control group 36% reduction RR 1,0 RR: 1,05 AH Olsen et al. BMJ, January 2005 Data from Fyn are currently being analysed using the same model

12 Changes in breast cancer incidence in the course of screening Incidence with screening Prevalence peak Artificial ageing Compensatory dip Incidence no screening Start of screening End of screening Ref.: E.Lynge

13 Risk of incident invasive breast cancer for women aged in Copenhagen and Fyn compared with the rest of Denmark AH Olsen et al. B J Cancer 2003; 88: 362-5

14 Overdiagnosis in Screening Mammography in Denmark? (= Breast Cancers that would not have been detected in absence of screening) Study group Copenhagen : 1 April March 2005 (Women aged years at 1 April 1991 ~ allow sufficient follow up period after screening) Funen: 1 November October 2004 (Women aged years at 1 November 1993) Follow up period (average) Copenhagen: 14.4 years Funen: 13 years Results Overdiagnosis (IC+DCIS): 1-5% Historical Local Control Group (Same birth cohorts, born 14 years prior) Historical National Control Group (Same birth cohorts, born 14 years prior) Region Age Non Screening Regions (Same births cohorts) Illustration af undersøgelsens design Illust Screened group during screening Screened group after screening Control groups No n-s creening Denmark At least 8 years follow up was needed to see the compensatory dip 76 Co p e n h a g e n Tim e Njor SHN, Olsen AH, Blichert-Toft M, Schwartz W, Vejborg I, Lynge E: Overdiagnosis in screening mammography in Denmark: population based cohort study. BMJ 2013;346: f1064 doi: /bmj.f1064

15 False positive screening test i.e. a woman recalled for assessment who is found not to have breast cancer More than 90 % of the false positives are sorted out at assessment/diagnostic mammography

16 Proportion of women with false positive test undergoing surgery before the suspicion of malignancy could be ruled out in th biennial mammography screening in Copenhagen Invitation Screen number Round Total % % 2 7.6% 5.9% % % 4.5% 6.7% - 8.2% 4 6.8% 4.1% 8.3% 6.9% 6.7% Total 12.0% 5.6% 6.9% 6.9% 9.9% 7.Round ( ) 6% (of 1,1%) I Vejborg et al ; J Med Screen 2002 ; 9: 115-9

17 Breast cancer mortality in a number of European countries, 2007 Denmark (2006)

18 Nationwide Mammography Screening in Denmark 14 counties 5 regions All regions had started in 2008

19 Targetpopultation in DK women aged years Northern Region Middle Region Southern Region Capital Region Zealand Region

20 Mammography Screening in Denmark Each of the 5 regions has: - centralized screening programme - population based invitation register - double blind reading - digital mammography equipment - PACS and RIS Retrieved from PACS, read on workstations, documented in RIS

21 Status for implementation of screening in the regions Område Population 1. K 2. K 3. K 4. K 1. K 2. K 3. K 4. K 1. K 2. K 3. K 4. K 1. K 2. K 3. K 4. K Region Hovedstaden Kbh og Fredb Kommune fra 1991/1994 Hvidovre 6000 Glostrup, Albertslund, Tåstrup Dragør, Tårnby 7300 Brøndby, Ishøj, Vallensbæk 8900 Bornholm 6600 fra 2001 Herlev, Gentofte, Rødovre Resten af Region H Region Sjælland Fhv. Vestsjællands Amt fra 2004 Resten Region Syddanmark Fhv. Fyns Amt fra 1993 Resten Region Midtjylland Region Nordjylland Ålborg Hjørring Total K 2. K 3. K 4. K 1. K 2. K 3. K 4. K 1. K 2. K 3. K 4. K 1. K 2. K 3. K 4. K Prævalensperiode Incidensperiode

22 National Mammography Screening A national challenge to ensure that the recommended guidelines are met

23 DKMS Dansk Kvalitetsdatabase for MammografiScreening (Danish Database for Quality Assurance of Mammography Screening) Initiated by the National Board of Health and Danish Regions Responsibilities of the steering committee: Work out national quality indicators ( done) Work out national clinical guidelines ( done) Generate and manage the database (on going) Surveillance and improvements of quality (on going) All regions are required to send specified data to the database IV 2012

24 National Clinical Guidelines of Mammography Screening Organizational requirements Personal invitations based on population register Information folder send with the invitation Every women in the target group invited every second year Written answers of the test result send to the women 2 standardized projections of each breast The screening programme has to full fill the organizational recommandations Dobble blind reading by two radiologist of which at least one of them read 5000 screening mammograms a year Steering group with a broad representation Appointed leader of the programme Centalized physical and technical quality assurance according to European Guidelines Data collections and centralized monitoring of the programme Vejborg I et al. Dan Med Bull 58(6):C4287 (2011), PMID

25 National Clinical Guidelines of Mammography Screening Radiographic quality standards > 97% of the examinations should be acceptable according to international standard -> Audit & feed back from radiologist < 3% should have repeated one or more views -> repeated examinations should be recorded > 97% of the women should be satisfied with the their screening -> questionnaire 100% of the women should be informed of the method and time scale for receiving the answer Vejborg I et al. Dan Med Bull 58(6):C4287 (2011), PMID

26 Danish Quality Database for Mammography Screening Results from 1st National Screening Round Vejborg I, Mikkelsen EM, Schwartz W et al. Ugeskr Læger 2012;174(42):2533

27 Mammography Screening in Denmark Final results DKMS 1 st Invitation Round Invited / Screened =>Participationrate 77% Recalled for diagnostic mammography= 3,0% 2.Invitation Round: Invited / Screened => Participationrate 81% Recalled =2,6% EU Guidelines: Participation rate >70%/ 75% EU Guidelines : Recall rate: 1 st screen: < 7%/ < 5%/ 2. screen : < 5%/< 3% IV 2013

28 Mammography Screening in Denmark Final results DKMS 1st and 2.National Invitation Round Women with breast cancer ( invasive + in situ) (2.Round: 3.164) In situ 649 (14%) ( 2.Round: 475 = 15%) European Guidelines: 10%-20 % in situ IV 2013

29 It is not enough to find a lot of cancers!

30 Mammography Screening in Denmark Final results DKMS 1st and 2. National Invitation Round Small invasive cancers 1 st round Region 1cm Invasive % 1cm 1 st round Capital ,2 45,0% Middle ,8 37,6% North ,9 34,4% Zealand ,6 42,5% South ,2 36,1% National ,7 39,4% European Guidelines: 1.screen 25%/ 2.screen 30% 2.Round

31 Interval cancer rate (i.e. number of women diagnosed with breast cancer in the 2- year period after being tested negative compared with the incidence in abscence of screening data from 2006) 12 months after 1st invitation round Standard: <30 % National result: 26,7% >12-24 months after 1st invitation round Standard: < 50% National result: 41% IV.2014

32 Final results DKMS 1st (and 2.Round) National Invitation Round Node negative cancers 67% (2.Round:69%) The only Medical Indicator that is not met! European Guidelines 1.screen: Desirable > 70 % 2.screen: Desirable > 75%

33 Mammography Screening in Denmark 1 st (and 2. Round) National invitation round Benign / malignant operation ratio Region Benign Malignant Ratio Capital :9,1 1:11,2 Middle :5,8 1:7,0 North :3,6 1:6,8 Zealand :7,2 1:7,7 South :5,8 1:6,3 National :6,3 1:7,6 European Guidelines Benign:malignant Acceptable: 1:1 Desirable: 1:2 2.Round

34 Mammography Screening in Denmark 1 st (and 2. Round) National invitation round Breast Conserving Surgery (women with screen detected invasive breast cancers) 80% (2.Round:81%) (Regional differences: 70%-87%) European Guidelines: >50%

35 Mammography screening has to have a balance between Benefits: Breast cancer morbidity and mortality and Harms: False positives, overdiagnosis Recently published reports from The UK Independent Panel on Breast Screening (Ref.: The benefits and harms of breast cancer screening: An independent review. Lancet 2012;;380: )..and from The Euroscreen Working Group (Ref.: Paci E. Summary of the evidence of breast cancer service screening outcomes in Europe and first estimates of the benefit and harm balance sheet. J Med Screen 2012;; 19: 5-13)..concludes that: Mammography screening do reduce breast cancer mortality and that the benefits by far exceedes the harms IV.2014

36 Walters S et al.: British Journal of Cancer (2013);1-14/ doi: /bjc Breast Cancer survival and stage at Diagnosis in Australia, Canada, Denmark, Norway, Sweden and the UK, : a population-based study Conclusions: - Survival in Denmark and UK was significantly lower than in the other countries - Distribution of stage at diagnosis was least favourable in Denmark..but stage specific survival was average in Denmark (but not in UK) National breast cancer screening for women aged 50-69/70 years were implemented in all these countries, except in Denmark IV. 2013

37 Ultimative Quality Indicators ( 8-10 years of screening) on Morbidity & Mortality of Breast cancer Breast cancer mortality in a number of European countries, 2007

38 Men.. kan vi gøre det endnu bedre?

39 Personaliseret Mammografiscreening Livstidsrisikoen for brystkræft er over 10 %, men ikke alle kvinder har samme risiko! Hvis vi kan identificere kvinder med hhv. høj og lav risiko for at udvikle brystkræft vil omkostningerne ved fremtidig screening kunne nedbringes uden reduktion i screeningseffekten Både brysttype og en lang række andre karakteristika influerer på risikoen for brystkræft Aktuelt baseres organiseret screening alene på alderskriterier:... One model fits all.. Densitets type 1 Densitets type 4 IV. 2012

40 Personaliseret Mammografiscreening Brystkræft risiko faktorer RR Nulliparietet / sen første fødsel 1.3 Alkohol 1.3 Menopausal hormon substitution 1.4 Fedme 1.5 Alder 65 år 1.7 Familiær anamnese 1.7 Høj densitet af brystvæv 4.0 Tidligere biopsi m. atypi eller LCIS 5.0 Tidligere brystkræft 7.0 Boyd NF.NEJM 2007/ RSNA 2013

41 Personaliseret Mammografiscreening Brystkræft risiko faktorer RR Nulliparietet / sen første fødsel 1.3 Alkohol 1.3 Menopausal hormon substitution 1.4 Fedme 1.5 Alder 65 år 1.7 Familiær anamnese 1.7 Høj densitet af brystvæv 4.0 Tidligere biopsi m. atypi eller LCIS 5.0 Tidligere brystkræft 7.0 Boyd NF.NEJM 2007

42 Personaliseret brystkræft screening Interval cancere og bryst densitet Densitet OR < 10% % % % % 17.8 Boyd NF et. Al. NEJM. 2007/ RSNA 2013

43 Personaliseret Mammografiscreening Stigende fokus på mammografisk densitet som risikofaktor for udvikling af brystkræft 16-28% af alle brystkræfttilfælde formodes at kunne tilskrives en høj densitet af brystvævet ( Boyd NF.NEJM 2007) Tæt brystvæv øger risikoen for store og lymfeknude positive cancere og må derfor formodes at influere på dødelighed af brystkræft Risikovurdering på store datamaterialer og en objektiv metode til vurdering af densitet efterspørges Densitets type 1 Densitets type 4 IV. 2012

44 Personaliseret Mammografiscreening 4-årigt projekt støttet af Højteknologifonden Samarbejde mellem Biomediq & Datalogisk Institut, Institut for Folkesundhedsvidenskab og Region Hovedstadens Mammografiscreeningsprogram om Udvikling og testning af software til automatisk billedanalyse af mammografisk densitet og tekstur for derved at bidrage med ny viden til vurdering af den enkelte kvindes risiko for at udvikle brystkræft IV. 2012

45 Personaliseret Mammografiscreening 4-årigt projekt støttet af Højteknologifonden Samarbejde mellem Biomediq & Datalogisk Institut, Institut for Folkesundhedsvidenskab og Region Hovedstadens Mammografiscreeningsprogram om Udvikling og testning af software til automatisk billedanalyse af mammografisk densitet og tekstur for derved at bidrage med ny viden til vurdering af den enkelte kvindes risiko for at udvikle brystkræft 2 retrospektive analyser af indscannede billeder på kvinder, der siden hhv og 2007 har fået konstateret brystkræft, er i gang. Prospektivt foretages indsamling af rådata fra kvinders screeningsundersøgelser i Region Hovedstaden over en 4-årig periode og sammenholdes med epidemiologiske data IV. 2012

46 Personaliseret Mammografiscreening Tomosyntese snit Potentiale Kvinder med estimeret høj risiko: Tilbud om mere intensiv diagnostik, eksempelvis tomosyntese eller semiautomatiseret UL på screeningsenhederne eller UL genindkaldelse til klinisk mammografi eller MR-mammografi -> tidligere detektion og dermed større overlevelseschance Kvinder med estimeret lav risiko: Mindre intensiv screening, eksempelvis øget screeningsinterval -> ressourcebesparelse uden fald i detektionsrate og reduktion i brystkræftdødelighed MR IV. 2014

47 Personaliseret Mammografiscreening Tomosyntese snit Potentiale Kvinder med estimeret høj risiko: Tilbud om mere intensiv diagnostik, eksempelvis tomosyntese eller semiautomatiseret UL på screeningsenhederne, genindkaldelse til klinisk mammografi eller MR -> tidligere detektion og dermed større overlevelseschance UL Kvinder med estimeret lav risiko: Mindre intensiv screening, eksempelvis øget screeningsinterval -> ressourcebesparelse uden fald i detektionsrate og reduktion i brystkræftdødelighed MR IV. 2012

48 Tak for opmærksomheden!