What’s new in BCSP pathology? Professor Neil A Shepherd Gloucester and Cheltenham, UK

Sorry – it’s not just BCSP…..

To consider how are we doing? roll-out of age extension and effect on pathology workload development of flexible sigmoidoscopy screening and effect on pathology workload diagnostic pathology issues QA issues

Roll out of the BCSP April 2006: call for first wave bids July 4 2006: first invitations go out March 31 2007: 15 screening centres April 2007: second wave begins March 31 2008: 33 screening centres April 3 2008: call for final wave bids January 2010: all 58 centres open August 2010: all 153 PCTs in BCSP Cancer polyp rate is as found in pilot and in Nottingham trial when looking only at 60-69 age group 4

58 screening centres First Wave Second Wave Final Wave Wolverhampton Norwich South Devon Cheshire & Merseyside St Marks South West London Gloucestershire Bolton Tees South of Tyne Humber & Yorkshire Coast Derbyshire North East London Solent and West Sussex University College London Second Wave Heart of England Coventry and Warwickshire Bradford & Airedale West London Cambridge County Durham & Darlington Leicestershire, Northampton & Rutland South East London North of Tyne South Yorkshire Dorset West Hertfordshire East & North Hertfordshire Nottinghamshire Hampshire Cumbria & Westmorland Sandwell & West Birmingham Somerset Final Wave Pennine Lancashire Berkshire North Staffordshire South Essex Surrey Sussex Bristol & Weston North Essex Bath, Swindon & Wiltshire Bedfordshire Cheshire Calderdale, Kirklees & Wakefield East Kent North & East Devon Harrogate, Leeds & York Peterborough & Huntingdon West Kent & Medway Hereford & Worcester Buckinghamshire Cornwall Shropshire Manchester Lincolnshire Oxford

Results of BCSP: up to 31 August 2011 attended SSP Clinic 129,542 DNA SSP Clinic 10,193 attended diagnostic test 124,830 DNA diagnostic test 658 people with polyps 44,377 (44.5%) cancers found 10,283 (8.95%) Cancer polyp rate is as found in pilot and in Nottingham trial when looking only at 60-69 age group exactly the stage shift in cancer (good pathology all important) in cancer that we would expect from pilots, etc 6

Uptake national uptake 54.88% national positivity 2.11% uptake varies from 35.02% to 65.28% London acceptance rate 44.85% national rate without London 57.01%

Episode outcomes (after positive FOB): latest data available all rounds prevalent incident cancers 8445 10.04% 6.06% high risk adenoma 8632 9.94% 7.24% intermediate risk adenoma 16,716 18.58% 16.15% low risk adenoma 15,735 15.87% 20.37% abnormal not polyps 17,478 17.49% 23.06% polyps no histology 511 0.48% 0.77% normal 23,307 25.31% 24.43% no result 2036 2.28% 1.92%

Age expansion of the BCSP July 2008 age expansion of BCSP from 70 to 74 years from April 2010 announced Sept 2008 early Implementer sites commenced invites to older population Jan 2010 first wave of age expansion across screening centres Oct 2011 33 screening Centres inviting older population BUT slow-down now in age expansion because of problems with endoscopy capacity

Age expansion of the BCSP Key  expanded  partially expanded  not expanded We have age expanded and, to be honest, we have seen very little change in workload What is others’ experience?

Further developments: Flexible sigmoidoscopy screening May 2010 Wendy Atkin publishes ‘Flexiscope’ trial results Oct 2010 PM announces flexi-sig programme to commence Jan 2011 ‘Improving Outcomes’ strategy for cancer published April 2011 National Screening Committee approves FS screening

Efficacy of a once-only flexible sigmoidoscopy @ 55 After 11 years of follow-up, in people who had the screening: cumulative incidence, including prevalent cancers detected at screening, reduced by 50% for distal cancers (rectum and sigmoid colon) 33% for colorectal cancer overall colorectal cancer mortality was reduced by 43% no sign of a lessening of effect at longer follow-up times one life saved per 200 people screened? 12 12

Timeline for development 2011/12 development year for Flexi-sig 2012/13 piloting of Flexi-sig 2013/14 first wave roll out of Flexi-sig: 30% open by 31 March 2014 2014/15 second wave roll out of Flexi-sig: 60% open by 31 March 2015 2016 roll out complete

Current issues 2011/12 problems with adapting BCSS for FS screening problems with procurement of enemas hence ‘development year for Flexi-sig’ for you and me, this means a year to develop pathology capacity to deal with effects of FS pilots (likely five sites – one per hub) will start in one year’s time

Pathfinder sites 3 screening Centres undertaken ‘pathfinder project’ – South of Tyne, Tees and Derbyshire – just completed testing organisational issues 3 different invitation processes initial findings available – evaluation report awaited

FS Pathfinder sites: 3 sites combined Trial total number invited 4022 57,254 number undergoing flexible sigmoidoscopy 1137 (28%) 40 674 cancer found 2 (0.2%) 131 (0.3%) number of individuals with ≥ 1 adenoma 111 (10%) 4,931 (12%) total number adenomas 143 ~6,200 colonoscopies generated 30 (2.7%) 2051 (5 %)

Best and worst Tees, Derby and South Tyne . Tees: lots of work for BCSP team and endoscopy units for minimal pathology yield Derby: workload (particularly admin) more than SC had envisaged. Relatively negative patient feedback. Pathology yield not as expected. South Tyne: ‘A far cry from the gold standard service we offer in BCSP’

Flexible sigmoidoscopy Three pilot sites: South Tyne, Derby & Tees surprisingly low take-up pathology not exactly taxing

Pathology breakdown: South Tyne Number of specimens Tubular adenoma low grade 53 Tubulovillous adenoma, low grade 4 Villous adenoma Carcinoma Hyperplastic polyp 68 Inflammatory polyp 8 Mucosal prolapse Normal colonic mucosa 11

What we didn’t see: South Tyne no cancers no high grade dysplasia no villous adenomas very little big stuff nothing weird nothing especially difficult (small sample)

James Henry (pathologist at Gateshead) on South Tyne FS Pathfinder study all histology received was relatively simple: we didn’t see any cancers in our part of the pilot. no big or complex polyps removed at first sigmoidoscopy. however, sigmoidoscopists had been told not to resect anything bigger than 10mm at screening sigmoidoscopy: hence the bias to lesions less than 10mm in diameter (wish someone had told me this before the meeting!). nothing big, dangly and difficult from the sigmoid on first screen . biggest issues: finding enough willing sigmoidoscopists getting the enemas to the subjects (postal regulations) practical issues about second enemas through the scope etc…. (issues that make me glad I’m a histopathologist).

The future of FS in BCSP Julietta is confident that the detection rates are comparable with the Atkin trial low uptake because of 3 different invitation strategies patients need a date, time, place and enema in the post!!! slow down for one year the workload for pathology may not be as great as was expected you have one year more to plan your strategy for increased workload, finance, etc

The three big issues in BCSP pathology the introduction of age expansion and flexible sigmoidoscopy and their implications for pathology workload continuing diagnostic and management issues with those difficult sigmoid colonic polyps, serrated pathology and polyp cancers QA visits and their repercussions

Expert Board Neil Shepherd, Scott Sanders and Marco Novelli still controversies and difficulties 105 cases referred to Expert Board Complete agreement between originating pathologist(s) and EB 26 Original diagnosis equivocal but EB diagnosis certain 41 Diametrically opposite diagnosis: originating pathologist(s) and EB 29 Both epithelial misplacement and cancer 5 Too difficult for EB (little or no agreement) 4

What issues have arisen in pathology QA for BCSP? funding funding for increased workload (eg age extension) difficulties in data extraction (your hub should do this) job planning for leads leads only leading in their own hospital attendance at MDTM high rates of HGD lack of provision of datasets – feedback from SSPs

Current ‘dataset’ for polyps in use in South West

BCSP Polyp Datasets POLYP 3: SITE - SIGMOID COLON SIZE - 2MM TUBULAR ADENOMA COMPLETENESS OF REMOVAL - N/A DYSPLASIA - LOW GRADE ADENOMA WITH CANCER - NO

Local excisions

Resection specimens

What issues have arisen in pathology EQA for BCSP? polyp measurements protocol for dealing with difficult cases communication with other staff, esp SSPs numbers of pathologists doing BCSP work in centres complying with EQA and education: BCSP update courses quality markers of cancer resection data for each BCSP pathologist (last 50 sequential cases): 1. median number of lymph nodes harvested 2. rates of serosal involvement for colonic and rectal cancer 3. rate of extramural venous spread for colorectal cancer 4. range of TNM and Dukes stages

Where are we with bowel cancer screening in the UK? so far, so good polyp and (early) cancer detection rates high uptake not bad (could be better in bigger cities) slow roll-out in some centres has meant we can’t ‘advertise’ on a national basis (we can now and you have seen it) age extension and FS not a huge problem for pathology a big thanks to you all from Julietta, Phil and the team (and, I’m sure, from our friends in BSW, SBSP, NIBCS)!