Challenges for Colorectal Cancer Screening
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1 Challenges for Colorectal Cancer Screening a Biomarker with No Standards! Prof. Emeritus Stephen P. Halloran University of Surrey
2 W. Europe Top 20 Cancers Men Incidence & Mortality (2012) Women World - Bowel Cancer 3 rd commonest cancer 4 nd cause of Ca deaths Incidence Mortality Western Europe 3 nd commonest cancer 2 nd commonest cancer death 1 st commonest cancer in non-smoking men? GLOBOCAN 2012 (IARC) Estimated age-standardised rates/100,000
3 Bowel Cancer Pathogenesis Case for Screening Dukes Stage A B C D Polyp Survival 5 years after treatment 93% 77% 48% 7% 10 years
4 Carbohydrate antigen 19-9 (CA 19-9) Candidate Screening Tests carcinoembryonic antigen (CEA) Methylated vimentin Epidermal growth factor receptor (EGFR)
5 Blood in faeces still the best screening marker for cancer & adenomas!
6 Faecal Immunochemical Test (FIT) Haemoglobin - Globin gfobt Specific to human blood Detects small bleeds Quantitative measurement Globin Haem Guaiac test gfobt
7 Available FIT Systems FOB Gold NG/ BioMajesty NS PLUS-C15 HM-JACKarc OC Sensor DIANA
8 Faecal Immunochemical Test The International Choice! European guidelines for quality assurance in colorectal cancer screening and diagnosis. Chapter 4. Faecal occult blood testing. Endoscopy 2012; 44 (S 03):SE65-SE87
9 FIT Measures Concentration of Haemoglobin Outcome Mean FIT Conc. ug Hb /g faeces Positives at 20 ug /g Cut-off Endoscopic Classification Mean FIT Conc. ug Hb /g faeces +ve at 20 ug /g Cut-off Normal 10 (1-20) 6.9% All Adenoma 14 (4-23) 9.3% Adv. Adenoma 81 (37-125) 34.5% Histology LGD % HGD % Size < 10 mm % Cancer 170 (89-252) OC-SENSA MICRO 84.6% 10 mm % Number < 3 adenoma % 3 adenoma %
10 Power of Quantitative FIT Multivariate Risk Scores Quantitative FIT concentration Age & Sex Screening history Multivariate Bowel Cancer Risk Score Indices of Deprivation Geodemographics (Postcode) Medical History IBD, Crohns, DM, etc Family History 1 st and 2 nd degree relatives Better Screening! PPV Cost Effectiveness Colonoscopy Referrals Life style Smoking, exercise, diet, obesity
11 FIT Why the challenge? 1. Haemoglobin is unstable in solution
12 FIT Why the challenge? 1. Haemoglobin is unstable in solution 13% less cancers detected in Summer vis Winter Grazzini, Halloran et al Gut. 2010
13 FIT Why the challenge? 1. Haemoglobin is unstable in solution 2. Same faeces, same units different Hb buffer concentrations (ng/ml) Do all devices give same results? Buffer Volumes - Different Faecal Sample Mass - dependent upon design of sampling device
14 FIT Why the challenge? 1. Haemoglobin is unstable in solution 2. Same faeces, same units different Hb buffer concentrations (ng/ml) 3. Assay calibration poorly defined What was used for Hb calibration?
15 FIT Why the challenge? 1. Haemoglobin is unstable in solution 2. Same faeces, same units different Hb buffer concentrations (ng/ml) 3. Assay calibration poorly defined 4. No mature External Quality Assessment Scheme (EQAS). Does FIT have a reliable EQAS?
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17 Faecal Immunochemical Tests Standardisation Product Hb Traceability Sample mass? Units of reporting EQAS Performance Claims Stability Sample mass Clinical sensitivity Analytical accuracy Procurement Critical attributes Desirable attributes Local requirements
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19 FIT Publications 2012 Young GP, Fraser CG, Halloran SP, Cole S. Guaiac based faecal occult blood testing for colorectal cancer screening: an obsolete strategy? Gut (7): Allison JE, Fraser CG, Halloran SP, Young GP. Comparing fecal immunochemical tests: improved standardization is needed. Gastroenterol 2012;142: Fraser CG, Allison JE, Halloran SP, Young GP. A proposal to standardize reporting units for fecal immunochemical tests for hemoglobin. JNCI (11):810-4 Fraser C, Allison JE, Young GP, Halloran S. Newer fecal tests: opportunities for professionals in laboratory medicine. Clin Chem 2012;58(6)
20 % Europe Population over 65 How many FIT Screening Tests? Conservative estimate Population 850 million 20% eligible 170 million 40% uptake, 2 yearly 4% positivity 70 million tests p.a. (3 m colonoscopies p.a.) FIT Can we afford to get it wrong?
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Colorectal cancer screening in England
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