The choice of methods for Colorectal Cancer Screening; The Dutch experience
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1 The choice of methods for Colorectal Cancer Screening; The Dutch experience Monique van Leerdam, Gastroenterologist, NKI-AVL, Amsterdam The Netherlands
2 Colorectal cancer CRC 2 nd cause of cancer related death > new patients each year in The Netherlands 5 years mortality rate 40-45% 2015; new CRC patients
3 Population based CRC screening? Screening and surveillance criteria Wilson en Jungner; 1. The disease is an important health problem 2. The burden of the disease and the number of patients that die of the disease is substantial 3. There are precursor lesions (adenoma) 4. Early detection increases prognosis
4 Choice of methods of CRC screening Test features Uptake Risks and burden Capacity Costs.
5 Screening methods Fecal tests - Chemical FOBT - Immunochemical FOBT - DNA Endoscopy - Sigmoidoscopie - Colonoscopie CT-colonography
6 Screening methods; FOBT Guaiac FOBT (gfobt) 2 fecal samples of 3 different stools guaiac + H 2 O 2 Oxidation Colour change Catalysed by heme Immunochemical FOBT (IFOBT) 1 fecal sample Fecal Hb + Latex anti-hba Antigen-antibody complex
7 Screening methods; FOBT Positive FOBT Colonoscopy
8 Efficacy of FOBT Several large and longterm RCT show a mortality reduction between % with guaiac FOBT However; Low sensitivity for CRC; Chemical test (gfobt); 11-37% Immunochemical test (ifobt); 66-75% Hardcastle Lancet 1996, Kronborg, Lancet 1996, Mandel, NEJM 2000, Morikawa, Gastroenterology 2005; Grazinni 2004; Saito, Int.JC 1995; Allison, NEJM 1996
9 Screening methods; endoscopy Sigmoidoscopy Anatomic extend: flexura hepatica Preparation: phophate enema Sedation: rare Colonoscopy Anatomic extend: cecum Preparation: 2-4L polyethylene glycol Sedation: often
10 Sigmoidoscopy / colonoscopy Positive test 1. Colorectal cancer 2. Advanced adenoma 3. 3 adenomas Positive sigmoidoscopy colonoscopy
11 Efficacy of sigmoidoscopy screening Once-only flexible sigmoidoscopy screening in prevention of colorectal cancer: a multicentre randomised controlled trial Wendy S Atkin, UK Flexible Sigmoidoscopy Trial Investigators individuals randomized (1:2) into sigmoidoscopy or control group. FU 11 jr ITT: 23% CRC incidence (HR 0.77 ( ) in sigmo group 31% CRC related mortality (HR 0.69 ( ) in sigmo group Atkin et al. Lancet 2010;375:1624
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13 Efficacy of sigmoidoscopy screening PP: 33% CRC incidence (HR 0.67 ( ) in sigmo group 43% CRC related mortality (HR 0.57 ( ) in sigmo group
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15 Efficacy of colonoscopy unknown No data about the effect of colonoscopy screening The expectation is that the incidence of CRC and the CRC related mortality will further decrease (around 70-90%)
16 Potential drawbacks of endoscopy screening Low uptake Complications Burden Capacity Costs
17 CT colography Detection of large adenoma and CRC Less burdensome than endoscopy? Positive test: Colonoscopy Limited data about uptake, adverse events, costs
18 Results of Dutch screening trials
19 Dutch CRC screening trials November > asymptomatic persons yr 1; Dutch FOBT trial Amsterdam/Nijmegen & Rotterdam (CORERO); FOBT/ Sigmoidoscopy 2; Rotterdam & Amsterdam (COCOS); colonoscopie/ CT AIM; uptake and feasibility
20 Results 1 st round FOBT and Sigmo Highest uptake with immunochemical FOBT, > 60% 100 Male Female 80 % Hol, Gut 2010 Univariate analysis gfobt ifobt Sigmo Hol et al, Gut 2010
21 Results 1 st round FOBT and Sigmo % Uptake % Positive % True test positives* True positives per 1000 invited gfobt ifobt Sigmoidoscopy * of those with positive test Hol, Gut 2010
22 Results 1 st round ifobt; positivity rate at different cut-offs 9 8 8,1 7 % ,8 5,7 4,8 4,1 4, gfobt 50ng 75ng 100ng 125ng 150ng Hol, Gut 2010; Hol, Br J of Cancer 2009
23 Results 1 st round ifobt; yield 3,0 2,5 2,0 3,2 2,7 2,5 Adv.adenoom CRC 2,3 2,3 Percentage (%) 1,5 1,0 0,5 1,2 0,0 gfobt 50ng 75ng 100ng 125ng 150ng Hol, Gut 2010; Hol, British Journal of Cancer 2009
24 Results 1 st, 2 nd, 3 rd round ifobt % Uptake % Positive test % True positives* True positives per 1000 invited 1st round nd round rd round 65 * of those with positive test Van Rhoon, Gut 2012
25 Cost-effectiveness analysis of ifobt Wilschut, Gastroenterology 2011
26 ifobt with limited coloscopy capacity Wilschut, JNCI 2011
27 Results COCOS trial (colo vs CT); uptake Invitees n =8842 Colonoscopy n =5923 CT colonography n =2919 Participants n = 1273 (22%) Participants n = 983 (34%) Stoop, Lancet Oncology 2012 P = <0.001
28 Results COCOS trial; diagnostic yield per 100 participants Advanced neoplasia Colonoscopy CTC P- value Advanced adenomas Carcinoma Stoop, Lancet Oncology 2012
29 Results COCOS trial; diagnostic yield per 100 invitees Advanced neoplasia Colonoscopy CTC P- value Advanced adenomas Carcinoma Stoop, Lancet Oncology 2012
30 Conclusions Dutch trials Highest uptake with immunochemical FOBT, > 60% FIT cut-off can be altered based on coloscopy capacity Good uptake during repeated invitations Uptake for sigmoidoscopy, colonoscopy, CTC low Hol, Gut 2010; Wilschut, Gastroenterology 2011; Wilschut, JNCI 2011; van Roon, Gut 2012; de Goede Gut 2012
31 Overall conclusions 1. CRC is an important health care problem 2. A well organized population based screenings program will reduce CRC burden and mortality 3. Based on simplicity, acceptance, test features and safety, the Dutch government has chosen the ifobt to be the optimal screening method for the Netherlands.
32 2013: start CRC screening in the Netherlands NRC Introduction of a population based CRC screening program for people 55 years of age and older Volkskrant
33 Dutch CRC screening program with ifobt Automated, quantitative test Variable cut-off (50, 75, 100 ng/ml) Do it at home test One sample Thin test, fits in an envelop No dietary restrictions
34 Dutch CRC screening program with ifobt All individuals years of age Biannual Invitation & ifobt by postage, including return envelop Cut-off 75 ng/ml
35 Dutch CRC screening program with ifobt
36 Dutch CRC screening program with ifobt
37 Dutch CRC screening program; ICT
38 Enrollment in steps
39 2013 New King Introduction of our CRC screening program!!
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