Morten Rasmusen Overlæge Ph.-D Abdominalcenter K Bispebjerg Hospital Chef for tarmkræftscreening i Region Hovedstaden

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1 Morten Rasmusen Overlæge Ph.-D Abdominalcenter K Bispebjerg Hospital Chef for tarmkræftscreening i Region Hovedstaden

2 Definition af screening Examinations of asymptomatic people in order to classify them as likely or unlikely to have the disease that is the object of screening. The goal of screening is to reduce morbidity or mortality from the disease among the people screened; this goal is attained by early treatment of the cases discovered Morrison 1 Important health problem 2 accepted treatment for recognized disease 3 facilities for diagnosis and treatment 4 suitable latent and symptomatic stage 5 suitable test or examination 6 test acceptable to population 7 natural history of condition understood 8 agreed on policy on whom to treat 9 Cost of finding economically balanced with overall health 10 case finding should be continuous process WHO

3 CRC incidence & mortality CRC screening Years of age Incidence male Incidence female mortality male mortality female

4 Aldersstandardiseret forekomst af nye tilfælde & dødsfald af CRC fra

5 CRC Incidence & Mortality Livstidsrisiko: 5 % Incidence Colon Rectum Total Female Male Total DCCG 2013 Mortality Years > 75 Total Female Male Total Cancer registret 2008

6 Fecal occult blood test G-FOBT Hemoccult-II I-FOBT OC-Sensor

7 Instruktion

8 Cochrane Review Reduktion af CRC dødelighed Studie GFOBT Kontrol RR 95%CI Minnesota 1999 Nottingham / / / / Fyn / / Göteborg 2005 Total inviterede Total deltager 252/ / / / Hewitson et al. 2008

9 Mortalitets reduktion ved GFOBT RCT s Minnesota Nottingham Funen Inviterede Gennemførte (%) Positiv test (%) Nedsættelse af CRC mortalitet (%) Median follow-up tid (år) 15,587 76,466 30,

10 Dødelighed følger stadie Hewitson et al. 2008

11 Overlevelse efter stadie Stadie Antal % 5-års overlevelse Dukes A Dukes B Dukes C Dukes D Ukendt Total England Diagnosetidspunkt

12 Stadiefordeling i Danmark Stadie DK København Vejle Fyn Screening FOBT Dukes A Dukes B Dukes C Metastaser Andet 7

13 Forekomst af nye CRC efter FOBT screening Mandel et al.2000 FOBT Hvert år Hvert andet år Kontrol CRC Incidens ratio 0.80 ( ) 0.83 ( ) 1.0 P-værdi < < 0.002

14 Gennemførlighedsundersøgelse Vejle og Københavns amt Inviterede (50-74 år) Deltagere (%) Positive test(%) (48) 2085 (2.5) Overlevelse med CRC (Cox-Mantel hazard ratio) CRC fundet ved Ratio 95%CI P-værdi Screening/DCCG < 0.01 Screening/nægtere < 0.01 Negativ/DCCG Lindebjerg Dan Med J 2014

15 Hemocullt-II i England Total (%) år Mænd (%) Kvinder (%) Inviterede Deltagere (52) (50) (54) Positiv test (2.0) (2.5) (1.5) Kræft (10) (12) 542 (7.8) Høj og mellem risiko adenomer (27) (31) (21) Clean colon (30) (24) (38) 83% af positive undersøgt 98% koloskopi Logan RFA et al. GUT 2012

16 Calvados study GFOBT versus IFOBT persons Between 50 and 74 years Population screening IFOBT 2 Immudia/RPHA GFOBT Hemmocult-II 6 tests Positive test followed by colonoscopi No follow-up Guittet et al. GUT 2007 Guittet et al. Br. J.Cancer 2009

17 Relative sensitivity Rate G-POS I-POS G-POS I-NEG G-NEG I-POS RSN (95% CI) Cancer (43) ( ) Retum ( ) Distal colon ( ) Proximal colon ( ) Advance adenomas (283) ( ) Rectum ( ) Distal colon ( ) Proximal colon ( ) Non-advanced adenomas (251) ( ) Guittet et al. Br. J. Cancer 2009

18 RCT GFOBT versus IFOBT 2 population RCT persons between years of aged Randomized between GFOBT og IFOBT IFOBT OC-Sensor one fecal sampel GFOBT Hemoccult-II 6 fecal sampels Positive tests followed by colonoscopy Van Rossum et al. Gastroenterology 2008 Hol et al. Br. J. Cancer 2009

19 RCT GFOBT versus IFOBT Participation rate Rinjnmond Nijmegen GFOBT IFOBT GFOBT IFOBT Invited Performed 2375 (50%) 2979 (62%) 4836 (47%) 6157 (60%) Positive test 65 (2.8%) 241 (8.1%) 117 (2.4%) 339 (5.5)

20 Diagnostic yield GFOBT versus IFOBT Rinjnmond Nijmegen GFOBT IFOBT GFOBT IFOBT CRC Advanced adenomas Advanced neoplacia

21 Colonoscopy & OC-Sensor 9989 persons years Colonoscopy IFOBT sensitivity 95 %CI CRC Advance adenomas Specificity 95%CI Clean colon CRC False-negative rate IFOBT 0.18 % NNS koloskopi 154 NNS IFOBT 208 (15 colonoscopies) Imperiale NEJM 2014

22 IFOBT versus colonoscopy Aged years Colonoscopy OC-Sensor Randomized Performed (19%) (34%) CRC Advanced adenomas Non-advanced adenomer Quintero et al. NEJM 2012

23 Diagnostisk udbytte efter 4 runder med OC-Sensor Screningsrunder Inviterede Deltagelse (%) 1660 (56) 1600 (63) 1179 (57) 1165 (63) Positive test (%) 72 (4.3) 67 (4.2) 43 (3.6) 51 (4.4) Avanceret neoplasia (%) 25 (1.51) 21 (1.31) 15 (1.27) 15 (1.29) CRC 5 (0.30) 1 (0,06) 2 (0.17) 1 (0.09) Crotta et al. 2014

24 Complications Colonoscopy Per koloskopier Bleeding 1.64 Perforation 0.85 Death Rabeneck et al Odds-ratio for complication according to annual colonoscopy volume of endoscopist

25 30 days complications Colonoscopy Complication per ( ) Bleeding 1.35 Perforation 0.33 complications Total Bleeding Perforation Endoscopist volumen < 300/year 1.18 ( ) 1.13 ( ) 1.49 ( ) Biopsi 1.21 ( ) 1.84 ( ) 0.66 ( ) Polypectomy by hot biopsi 5.63 ( ) ( ) 1.22 ( ) Polypectomy by snare 7.75 ( ) ( ) 1.56 ( ) Chukmaitov et al. Endosc 2013

26 Invitations algoritme År Fødsels måned 2014 Juni april september 2015 November august januar 2016 Maj juli oktober 2017 Marts februar december Borgere der ikke er inviterede tidligere inviteres 1 mdr. før 75 år Borgere der bliver 50 år inviteres 1 mdr. Før deres fødselsdag

27 Den estimerede belastning personer 60% deltagelse 8 års karantæne Personer Positiv 5.4% Ingen koloskopi Personer personer Clean colon 2750 personer Lav risiko adenomer Personer Høj/mellem risiko adenomer Persons CRC Personer

28 Behov for koloskopi incl follow-up Antal koloudredninger DK 2012 Hospital Speciallæge I alt Antal koloskopier i Danmark

29 Deltagelse per uge 100,0% 90,0% 80,0% 70,0% 60,0% Region Nord Region Midt Region Syddanmark Region hovedstaden Region Sjælland 50,0% 40,0% 30,0% 20,0% 10,0% 0,0%

30 Deltagelse 11 november 2014 Region Antal udsendt invitationer Uge Svarprocent Uge svarprocent Nord Midt Syddanmark Hovedstaden Sjælland Hele landet

31 Deltagelse og alder Alder (år) Antal Inviterede Deltagelsesprocent Total

32 Antal positive Region Modtaget Uegnet Positive svar Positiv % Nord Midt Syddanmark Hovedstaden Sjælland Hele landet

33 Positive Alder N Antal Positive test % Mænd % Kvinder % Total