A von and G loucestershire Y oung O nset C olorectal C ancer SWAGYOCC Study David Messenger Consultant Colorectal Surgeon University Hospitals Bristol A retrospective multicentre observational cohort study of the diagnostic pathways management and outcomes of adults aged u ID: 930769
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Slide1
The Somerset, Wiltshire, Avon and Gloucestershire Young-Onset Colorectal Cancer (SWAG-YOCC) Study
David MessengerConsultant Colorectal SurgeonUniversity Hospitals Bristol
Slide2‘A retrospective multicentre observational cohort study of the diagnostic pathways, management and outcomes of adults aged under 50 years with colorectal cancer in the Somerset, Wiltshire, Avon and Gloucestershire Clinical Alliance’
Slide3Aim‘To determine the feasibility of capturing data on all adults <50 years diagnosed
with colorectal cancer in the SWAG Clinical Alliance from September 2009 to September 2019
in order to describe their epidemiology, diagnostic pathways, management and outcomes’
Slide4BackgroundWorldwide, US, UK (English) and European incidence trendsDemographic trends in young onset colorectal cancer in EnglandProjected impact on the South WestWhat is known about young onset colorectal cancer
Slide5Worldwide IncidenceFerlay et al., GLOBOCAN 2012
, IARC20121.4 million
20302.2 million
Slide6US Incidence Trends
Siegel et al., JNCI 2017
Zauber, Dig Dis Sci 2017
Slide7English Incidence Trends
Colon
Rectum
Chambers et al.,
Br J
Surg
2020
Slide8European Incidence Trends: Young adultsDriven by rise in proximal > distal tumours
Vuik et al., Gut 2019
Slide9Demographic trends in England: Site
Chambers et al.
Br J
Surg
2020
Slide10Demographic trends in England: Region
Proximal
Distal
Chambers et al.
Br J
Surg
2020
Slide112016 Incidence estimates: South West
Age group (yrs)
2016 population
2015 Incidence rate
(per 100,000)
Estimated number of cases in 2016
%
20-29
410,100
1.5
6.2
4.0%
30-39
367,700
6
22.1
40-49
407,700
16
65.2
50-59
437,900
55
241
96.0%
60-64
192,700
120
231
65-69
213,100
139
296
70-74
172,500
214
369
75-79
124,400
295
367
80-89
154,900
394
610
90+
37,300
350
131
Total
2,518,300
92.9
2338.5
Slide122041 Incidence estimates: South West
Age group (
yrs)
2041 population
2041 Projected Incidence rate (per 100,000): current APC
Estimated number of cases in 2041: current APC
%
2041 Projected Incidence rate (per 100,000): SW-specific APC
Estimated number of cases in 2041: SW-specific APC
%
20-29
443,700
5.0
22.2
7.2%
16.3
72.3
30.0%
30-39
408,000
19.8
80.8
65.0
265
40-49
413,200
21.6
89.3
173
716
50-59
433,100
72.3
313
92.8%
72.3
313
70.0%
60-64
207,100
105
217
105
217
65-69
211,700
31.2
66.1
31.2
66.1
70-74
230,700
57.5
133
57.5
133
75-79
216,400
198
429
198
429
80-89
277,800
358
995
358
995
90+
92,500
333
308
333
308
Total
2,934,200
90.4
2653.4
120
3514.4
Slide13Young onset rectal cancer: Norway
<40 years
≥40 years
P-value
At presentation
Poorly differentiated
27%
14%
0.014
N2 disease at presentation
37%
16%
0.001
Metastatic disease at presentation
38%
22%
0.019
Treated with curative
intent
Develop metastatic
disease
56%
23%
0.003
5-year
Overall Survival
54%
80%
0.029
Endreseth
et al. (Norwegian Rectal Cancer Group),
Dis Col Rectum
2006
Slide14Young onset colorectal cancer (sporadic): US
Tumour location
n
%
Proximal
25
17%
Left
34
23%
Rectum
91
61%
Group
3-year OS
5-year OS
10-year OS
Overall
76.2%
66.8%
58.6%
Genetic/IBD
94.6%
91.4%
87.9%
Sporadic
70.6%
61.5%
53.3%
Molecular feature
<50
yrs
50-59
yrs
60-69
yrs
70-79
yrs
80+
yrs
CIMP-H
0%
5%
18%
28%
42%
BRAF mutation
0%
2%
8%
15%
20%
MSI-high
0%
14%
23%
28%28%
Chouhan et al., Dis Colon Rectum 2019
Kozak et al., Colorectal Dis 2017
Liang et al.,
Int J Colorectal Dis
2015
Slide15RationaleYoung onset colorectal cancer is increasingDriven by increase in distal tumours in EnglandSouth West experiencing >10% per annum increase in distal tumour incidenceBy 2041, young adults may account for up to 30% of all casesLack of detailed understanding of characteristics of the young onset colorectal cancer populationLikely more advanced at presentationNo UK data
Slide16Study DesignTwo-phase retrospective observational cohort studyPhase 1: University Hospitals Bristol, North Bristol, Royal United Hospital
Phase 2: Taunton & Somerset, Yeovil District Hospital, Gloucestershire Hospitals, Weston General Hospital, SalisburyCompletion of Phase 1 will demonstrate deliverability
of Phase 2All adults aged <50 years with new
diagnosis
of colorectal cancer are
eligible
Slide17Inclusion/Exclusion CriteriaInclusion criteriaAged from 18 to 49 years at the time of diagnosis between September
2009 and September 2019Biopsy proven adenocarcinoma of the colorectum Exclusion
criteriaAged under 18 years or over 49 years at the time of
diagnosis
Non-
adenocarcinomas
of the
colorectum
Appendiceal
neoplasms
Neoplasms
of the anal canal or
perianal
region
Previous
diagnosis
of a colorectal
adenocarcinoma
before
September
2009
Slide18Outcome measuresPrimary outcome measureComplete data collection on ≥90% of cases presenting via the multidisciplinary team (MDT) at each
hospital trust Key secondary outcome measuresProportion of cases presenting as an emergency
Proportion of cases with stage IV disease at presentationProportion of cases undergoing
resection
with
curative
intent
Response
to
neoadjuvant
therapy
Local
recurrence
,
Disease
free
survival
,
Overall
survival
Proportion of cases
with
stoma
at 18
months
following
surgery
Proportion of cases in
each
data
field
submitted
to the NBOCA
where
data entry
is
correct
(
highlighted
as important
outcome
by ACPGBI PPI group)
Slide19Sample Size EstimatesNo formal power calculation is required as primary endpoint is to demonstrate completeness of data collectionAverage of ≈120 eligible cases over last 10 years per TrustAssuming ≥90% complete data collectionPhase 1 (UHB,NBT,RUH): 0.9 x 120 x 3 = 324Phase 2 (YDH,TST,WHAT,GH,SAL): 0.9 x 120 x 5 = 540
Total = 864
Slide20Data CollectionSurgical trainees will collect data and be supported by nominated consultant PI at each Trust (Research collaborative model)Identification of cases from Somerset Cancer Registry and data submissions to NBOCADirect date entry onto electronic case report form on REDCap databasePseudoanonymised data with unique study ID
Logic checksStudy period chosen to coincide with widespread use of electronic medical records3-month data collection period anticipated for each phase
Slide21Dissemination of ResultsInvestigators can present Trust level data at departmental meetingsData from phase 1 and 2 to be presented to key stakeholdersSWAG Clinical AlliancePatient Support GroupsPrimary Care GroupsPresentation at national/international conferencesSubmission to peer reviewed journalsAll publications will be attributed to the ‘SWAG-YOCC’ group
Slide22Future DirectionsProvide platform for prospective multicentre observational studyDemonstration of feasibilityAllow collection of additional data fields: quality of life, tissue samplesInform design of studies addressing key questionsEffectiveness of neoadjuvant therapy in young adultsTiming of surgery within treatment pathwayExpansion of FIT usage as screening tool in young adults
Allow linkage to future biomolecular and epidemiological studies
Slide23Steering Group MembershipUniversity Hospitals BristolDavid Messenger, Adam ChambersNorth Bristol TrustAnn LyonsRoyal United HospitalsIsi Tonga, Ed CourtneyUniversity of BristolProfessor Richard Martin, Professor Caroline Relton (Epidemiology)
ACPGBIProfessor Bob Arnott (Patient Liaison Group & NBOCA Patient Panel Chair)
Nominated lead Consultant & Surgical Trainee contact at each Trust
Slide24Current StatusSponsorship obtained from University Hospitals BristolProtocol currently undergoing peer reviewEthical approval to be sought through Proportionate Review Service REDCap database built and undergoing testing