Be it Resolved that FIT is the Best Way to Screen for Colorectal Cancer

DEBATE

DEBATE Presenters

PRESENTATION MODERATOR

Dr. Praveen Bansal -MD, CCFP FCFP

Regional Primary Care Lead, Integrated Cancer Screening, MHCW Regional Cancer Program

PRO COLONOSCOPY SPEAKER

Dr. Paul Philbrook - MD, CCFP

Regional Primary Care Lead, Integrated Cancer Screening, MHCW Regional Cancer Program

PRO FIT SPEAKER

Dr. Andrew Bellini – MD, FRCP (C)

Regional Lead, Colorectal Screening/GI Endoscopy

DEBATE Agenda

1.0 Ground Rules & Introduction – 7 mins

2.0 Pro Colonoscopy Argument – 8 mins

3.0 Pro FIT Argument – 8 mins

4.0 Panel Discussion & Audience Q & A – 7 mins

DEBATE Grand Rules

#1 Each SPEAKER will have an opportunity to state their case without questions or interruptions.

#2 AUDIENCE, please save your questions and comments for the panel discussion portion of today’s presentation.

#3 Event staff will be keeping track of the time for each section.

Introduction- Colorectal Cancer in Ontario

• In 2015, approximately 5,110 men were diagnosed

with colorectal cancer and approximately 1,850 died

from it

• Second leading cause of cancer deaths

• In 2015, approximately 4,100 women were

diagnosed with colorectal cancer and approximately

1,500 died from it

• Third leading cause of cancer deaths

Colorectal cancer is the 3rd most commonly

diagnosed cancer in Ontario

Introduction- Principles of Cancer Screening

Characteristics of an IDEAL screening test:

• Condition should be reasonably common in screened population

• Condition should be burdensome

• Safe and easy to implement screening test

• Pre- or cancerous lesion detectable and treatable

Improved mortality Cost effectiveWHO. Screening for various cancers. Cited: Mar 2016.

http://www.who.int/cancer/detection/variouscancer/en/

Introduction- Ontario’s Colorectal Cancer Screening Program

• Other options (outside of CCC) for CRC screening:

o Flexible Sigmoidoscopy

o Colonoscopy

• Developed and implemented by Cancer Care Ontario

• Men and women aged 50 –74, who are at average risk of colorectal cancer should be screened using the Fecal Occult Blood Test (FOBT) every 2 years

• Average risk: no personal or family history of colorectal cancer, no symptoms of colorectal cancer

• If an individual’s FOBT result is positive, the MRP coordinates a colonoscopy

Introduction - Background

Cancer Care Ontario is changing the average risk colorectal cancer screening test from the FOBT to the Fecal Immunochemical Test (FIT)

Fecal Occult Blood Test (FOBT)

Challenges with FOBT• Limited uptake from primary care

providers and endoscopists• Limited buy in from public due to dietary

restrictions and number of samples required

Benefits of FIT• Better test (sensitivity, specificity)• Higher participation rates in

programmatic screening are expected (one sample, no dietary restrictions, primary care uptake)

Introduction - Background

Advantages of FIT versus FOBT

• Easier to collect

• No dietary restrictions

• One specimen

• Less stool contact

Better usability

16% IMPROVEMENT in

participation over gFOBT

• Great for detecting advanced adenomas

• Better than gFOBT at detecting cancer

• Simple, safe and accessible

Introduction – Accuracy FIT vs. FOBTg

Sensitivity Specificity

FIT1

(n=19 studies)

82% 94%

gFOBT2

(n=9 studies)

47.1% 96.1%

FIT has improved sensitivity

with minimal loss of specificity1Lee J, et al. Ann Intern Med 2014;160:171-181.

2Canadian Task Force on Preventive Health Care. Screening for Colorectal Cancer. 2014.

Introduction – Definitions

The benefit of Colorectal Cancer(CRC) Screening is NOT

up for debate!

“If you wish to converse with me, define your terms.” Voltaire

Introduction - Programmatic vs Opportunistic Screening

Programmatic

Screening

Offered systematically to

all individuals in defined

target group within a

framework of agreed

policy, protocols, quality

management, monitoring

and evaluation

E.g. CCC Program, FOBT

Opportunistic

Screening

Offered to an individual

without symptoms of the

disease when he/she

presents to a healthcare

provider for reasons

unrelated to that disease

Introduction – Advanced Polyp or Lesion

What we prefer to see…. What we struggle to see..

Introduction – Advanced Polyp or Lesion

What we don’t want to see…

• As an physician, finding a cancer feels like a failure

• A missed opportunity for prevention

Introduction - Definitions

Advanced Polyp or Lesion

• Size (> 1 cm)

• Histology ( High Grade dysplasia, villous histology, Cancer)

• Screen Relevant Lesion is a cancer or an advanced polyp

DEBATE

Colonoscopy versus FIT for

Average Risk Colorectal

Cancer Screening

DEBATE

Pro Colonoscopy

Pro Colonoscopy – Accuracy

Sensitivity Specificity

FIT1

(n=19 studies)

82% 94%

Colonoscopy(Ir J Cancer prevention, 2011)

94.7% 99.8%

FIT less accurate for colon

cancer, even worse for

advanced adenomas

1Lee J, et al. Ann Intern Med 2014;160:171-181. 2Canadian Task Force on Preventive Health Care. Screening for Colorectal Cancer.

2014.

Colonoscopy

(n=4953)

FIT

(n=8983)

CRC 30 18

Advanced adenoma 514 127

Quintero E., et. al., NEJM 2012;366:697-706

Patients that Agree to Screening

Pro Colonoscopy- Diagnostic Yield

Pro Colonoscopy - Sessile Serrated Polyps

• Approximately 20-30% of CRC felt to arise from Sessile Serrated Polyps

• These are hard to detect via colonoscopy and not detectable by FIT

Pro Colonoscopy - Cost, Convenience and Opportunity

• Colonoscopy if normal needs be done only once every 10 years; may be advantageous for hard to reach populations (remote areas)

• Heitman et al in 2010 showed FIT to be most cost effective strategy for CRC screening of average risk individuals (Canadian costing)

• However, if administrative costs >$50 per case, colonoscopy became the most cost effective model

Colonoscopy - Programmatic vs. Opportunistic Screening

• Programmatic screening felt to be the best approach by most experts

• USA has opportunistic model with colonoscopy as the primary strategy

• They have one of the highest participation rates in the world and the largest yearly decline in CRC incidence and mortality (annual decreases of 3-4%/year since 2000)

Pro Colonoscopy- Does One Size FIT all?

• Are we trying to provide population centred care or person centred care?

• Does patient preference play a role?

• Should we promote colon cancer screening, have a great FIT program and (not or) offer colonoscopy screening to those who prefer this method?oTarget higher risk groups (Smokers, African

Canadians) and those most likely to benefit and less likely to be harmed for colonoscopy i.e. younger populations

Pro Colonoscopy – Conclusion

• Colonoscopy is the best way to screen for CRC

• Better accuracy, more opportunity for prevention

• Finds Sessile Serrated Polyps; FIT doesn’t

• Opportunistic screening can be effective and should be combined with population based FIT screening

• Patient should be involved in the choice

• May be more cost effective

DEBATE

Pro

Fecal Immunochemical Test

(FIT)

Pro FIT – As good as Colonoscopy

• Large RCT in Spain

• Ages 50 – 69 yrs old

• *FIT Q 2 yrs versus one-time colonoscopy

• Mailed invitation to participate

• Primary outcome: CRC-death at 10 yrs

Quintero E., et. al., NEJM 2012;366:697-706

*Selected cut-off: 75 ng Hb/ml

Evidence

Pro FIT – As good as Colonoscopy

26,599

invited for FIT

Quintero E., et. al., NEJM 2012;366:697-706

26,703

invited for colonoscopy

36% responded 28% responded

8983 completed

FIT

4953 completed

colonoscopy

23% offered colonoscopy

opted for FIT

1% offered FIT

opted for colonoscopy

Overall FIT participation: 34.2%P<0.001

Overall c’scope participation: 24.6%P<0.001

Pro FIT- As good as Colonoscopy

Colonoscopy

(n=26,703)

FIT

(n=26,599)

P-value

CRC 30 33 N.S.

Advanced adenoma 514 231 <0.001

# needed to screen to

find 1 CRC

191 281

# needed to scope to

find 1 CRC

191 18

Complication rate 24 10 <0.001

Quintero E., et. al., NEJM 2012;366:697-706

N.S. Not significant

Diagnostic Yield – Intention to Screen

Pro FIT- As good as Colonoscopy

• FIT has 40+% Advanced Adenoma detection rates

• Improved sensitivity of FIT vs FOBT makes it a good test to detect advanced adenomas as well, particularly if repeated at biannual intervals

Other Evidence

Pro FIT - Risk of Harm with Colonoscopy

• Consider…

• 95% of people being screened will never die of CRC

• These people can only be harmed by screening

• Even very small risks can expose large groups to harm

oShould we start with the most invasive test first?

Primum Non Nocere

Pro FIT - Risk of Harm with Colonoscopy

Colonoscopy Associated Complications

Pooled*

N= 97,091

Ontario

N= 67,632

Bleeding 1.64/1000 101

Perforation 0.85/1000 40

Death N/A 5

Rabeneck L., et. Al., Gastroenterology 2008; 1899-1906.

Pro FIT – Patient Preference

26,599

invited for FIT

Quintero E., et. al., NEJM 2012;366:697-706

26,703

invited for colonoscopy

36% responded 28% responded

8983 completed

FIT

4953 completed

colonoscopy

23% offered colonoscopy

opted for FIT

1% offered FIT

opted for colonoscopy

Pro FIT – Patient Preference

• Simple, easy to collect and no dietary restrictions, as compared to FOBT

• Completed from the comfort of home

• No visit to hospital for a screening test or having to take a day off work

• No arduous prep, as compared to colonoscopy

Pro FIT – Primary Care Preference

34CCSC 2015; courtesy of Dr Bob Hilsden

FIT introduced Nov 20130

500

1000

1500

Refe

rral V

olu

me

Jan/13 Apr Jul Oct Jan/14 April July OctMonth

gFOBT+/FIT+ Average Risk for CRC

Figure 3: 2013-14 Monthly Referral VolumesMonthly referral for colonoscopy, 2013-2014

Market Forces of Alberta FIT Roll Out

Pro FIT – Cost and Value

0

10

20

30

40

50

60

70

80

90

100

Average Risk FIT+

Perc

enta

ge

Cancer

Low risk adenoma

Low risk adenoma

Advanced adenoma

Advanced adenoma

Cancer

Lesions Detected at Colonoscopy

Normal

Normal

Pro FIT - FIT+ Colonoscopy Outcomes

Pro FIT – Conclusion

• FIT is the best test for population based CRC screening

• Easy for patients, higher participation (reach more people, more effective, prevent more CRC deaths)

• Highest yield - targets those most likely to benefit from a colonoscopy

• Lowest cost - both cost effective and less potential for harm

• Best suited for a centralized population based screening program –best opportunity to reach all communities and populations (diversity)

DEBATE

Panel Discussion and

Audience Q & A

DEBATE

Thank you

Check out the FIT HUB for Primary Care at:

https://archive.cancercare.on.ca/fithub?redirect=

true