Colorectal Screening New options for an old problem..

Does it make Sense?

John Bosco MD, FASGE

Aurora Medical Group

Department of Gastroenterology

WSGNA Spring meeting 2019

Colonoscopy in fact is well tolerated and safe….but that

darn prep

youtube

Agenda

• A brief review of colorectal cancer screening practices

• Focus a bit on Cologuard – as a potentially “disruptive innovation” in clinical practice

• Alternatives to colonoscopy to consider and Discuss the inferiority of these alternatives

• Questions

Learning Objectives

At the end of this presentation, you’ll be able to

1. Recommend the best screening option for all patients 2. Discuss the pros and cons of colorectal screening tests alternatives with

patients 3. Address patients’ fears and concerns over screening tests 4. Better address questions about new screening options that are available

Why are we talking about colon cancer?

Colorectal cancer(CRC)

is a very common

problem “Common problems occur

commonly”

3rd leading cause of mortality

in men and woman

135,000 newly diagnosed

CRC annually

60,000 deaths annually

Colon cancer: the problem

Early detection AND prevention has had a positive impact on incidence and mortality mostly as a result of the approval of colonoscopy for screening purposes. (July 1st, 2001)

high rate of utilization of an alternative CRC screening test (Cologuard) within Aurora.

Aggressive direct advertising campaign

Wisconsin based company

PCP’s are not prepared to dialogue with patients. Who are increasingly asking for it*

*my opinion*

Is this a colonoscopy in a box?

A disruptive force in colon cancer screening has

arrived

Celebrities are getting behind this technology-

Aggressive marketing

Google search result on 8/10/2017

Colorectal Screening

The more the merrier….thats the name of the game

• Importance of having all patients be screened is key – whatever test they are willing to use is most important when dealing with a non-compliant population (28%) (Aurora is at 80% in 2016)

• We know of the non-compliant population – insurance coverage may not be the barrier – it is more likely something the patient fears

• Cancers in the colon are developing in younger patients, with an alarming increase in the 20-39 year old population.

Cologuard orders in The Aurora system.

Multitarget Stool DNA Testing for Colorectal-Cancer

Screening •Thomas F. Imperiale, M.D., David F. Ransohoff, M.D., Steven H.

Itzkowitz, M.D., Theodore R. Levin, M.D., Philip Lavin, Ph.D., Graham P.

Lidgard, Ph.D., •D.

2014, NEJM article. Approved as a screening option for patients.

Cologuard vs Fit

All abnormalities were detected by colonoscopy

Alternative options in patients refusing colonoscopy

• Cologuard and FIT can detect most colon cancer but are not effective at preventing colon cancer.

• 8% chance of having their cancer being missed by the cologuard test. • 26% chance of it being missed by FIT. • 30%-95% chances of missing pre-cancerous polyps.

Cologuard vs. FIT

Taking off polyps a life saving endeavour

Colonoscopic Polypectomy and Long-Term Prevention of Colorectal-Cancer Death•Ann G. Zauber, Ph.D., Sidney J. Winawer, M.D., Michael J. O'Brien, M.D., M.P.H., Iris Lansdorp-Vogelaar, Ph.D., Marjolein van Ballegooijen, M.D., Ph.D.,

•Benjamin F. Hankey, Sc.D., Weiji Shi, M.S., John H. Bond, M.D., Melvin Schapiro, M.D.,Joel F. Panish, M.D., Edward T. Stewart, M.D.,

•and Jerome D. Waye, M.D.

•Among 2602 patients who had adenomas removed during participation in the study, after a median of 15.8 years, 1246 patients had

• died from any cause and 12 had died from colorectal cancer. Given an estimated 25.4 expected deaths from

• colorectal cancer in the general population

Impact of removing polyps

National polyp study

(Winawer et al)

Adenoma Carcinoma Sequence 10-15 year interval

http://article.sciencepublishinggroup.com/journal/158/1581015/image003.jpg

Adenoma Carcinoma sequence can it be interrupted? http://slideplayer.com/slide/6115187/18/images/5/Adenoma-

Carcinoma+Sequence+Accumulation+of+Mutations+DCC,+MCC,+p53,+K-ras,+APC,+MSH2,+MLH1,+etc..jpg

A Hunting we will go…..

Finding polyps is a good thing.

ADR----adenoma detection rate is quality measure that has wide

adoption

Withdrawal time is used as a surrogate marker of ADR

losing steam as a measure

Accessories to colonoscopes and modifications are being popularized

and received towards

caps

multi-camera endoscopes/ high definition/

How to improve ADR…

Good preps

Slow withdrawal

2 sets of eyes!!!—that’s where you can help, Pay attention

TEAM SPORT!

Caps on the scope.

Visual improvements

“Third eye”

3 camera scope system.

• Cologuard

• Colonoscopy

• Invasive

• Cost effective

• PREVENTS colon cancer

• 53-90% reduction in incidence in screened patients.

• Detects precancerous lesions

• Identifies and removes lesion at same setting

• Very low false positives

• Highest rate of colorectal neoplasia detection

• It is the Gold standard

• It is a covered benefit

Colonoscopy vs. Cologuard

Does FIT fit in ??

Performance Characteristics of Fecal Immunochemical Tests for Colorectal Cancer and Advanced Adenomatous Polyps: A Systematic Review and Meta-analysis

Annals of Internal medicine. March 2019

- A threshold of 10 µg/g resulted in sensitivity of 0.91 (95% CI, 0.84 to 0.95)

- a negative likelihood ratio of 0.10 (CI, 0.06 to 0.19) for CRC,

- greater than 20 µg/g resulted in specificity of 0.95 .

- Equal to that of Cologuard!

That’s a polyp…

5 Year interval colonoscopy

They will come back

55 y/o male 5 year interval colonoscopy

had a small adenoma 5 years ago.

Cologuard may miss these

51 year old male initial average risk screening colonoscopy

If cologuard/FIT was ordered significant probability it would have been negative.

Removal of polyp

False positives

• Cologuard - 45% • FIT – 36%

• In this scenario most insurance companies will now consider

the colonoscopy to be diagnostic vs screening. • More out of pocket expense for the patient

Indications for Cologuard

If patients understand all of the pros/cons and still refuse to use their Preventive Care Benefit for a screening colonoscopy, then the following conditions should be present.

• No family h/o colon cancer (and in my opinion, colon polyps) • No personal h/o of IBD • No symptoms , no bleeding , diarrhea or abdominal pain. • No personal h/o colon cancer or polyps. • *No prior positive Cologuard test*

Shared decision-making with your patient

Screening Options for at home testing • Cologuard every 3 years *- PCP tracks compliance/recall • FIT Fecal immunochemical testing for blood (FIT) annually - PCP tracks

compliance/recall Screening Option for detection AND prevention • Sigmoidoscopy alone every 5 years - GI tracks recall • Colonoscopy every 10 years - GI tracks recall • Barium enema • CT Colonography - ordering provider tracks recalls *No published data to support recommendation

Addressing patient concerns/fears to ensure compliance • Insurance coverage – out of pocket expense for your patient • Convenience • Frequency of testing • Prep • False positives with Cologuard and FIT

Considerations

• Cost Considerations

• If colonoscopy is done as a screening then it is 100% covered as a screening test.

• If patients have a positive Cologuard then they need the colonoscopy that they are refusing at which point the colonoscopy is considered a DIAGNOSTIC test and all patient deductibles and copays apply.

• Practice Considerations

• There have been challenges with reporting of Cologuard results and compliance with testing. 56% compliance in AHC.

• Interval for Cologuard is not well studied, the 3 year interval has been selected mostly on cost issues.

• Positive result does not distinguish between blood and biomarker abnormalities.

Considerations (con’t)

• Patient Considerations

• Providers and patients may underestimate the inferiority of alternative screening methods.

• Lack of consistent follow up for abnormal results. • Providers may not be explaining these differences adequately.

• Potential/medical legal concerns - “A negative Cologuard test result does not guarantee absence of

cancer or advanced adenoma. Patients with a negative Cologuard test result should be advised to continue participating in a colorectal cancer screening program with another recommended screening method. The screening interval for this follow-up has not been established.” (Cologuard label)

34

Cologuard FDA Labeling Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals.

Indications for Use

Contra-indications

Cologuard is intended for use with patients, age 50 years and older, at average risk who are typical candidates for CRC screening. Cologuard was not clinically evaluated for the following types of patients:

Patients with a history of colorectal cancer, adenomas, or other related cancers.

Patients who have had a positive result from another colorectal cancer screening method within the last 6 months.

Patients who have been diagnosed with a condition that is associated with high risk for colorectal cancer.

Patients who have been diagnosed with a relevant familial (hereditary) cancer syndrome.

The performance of Cologuard has been established in a cross sectional study (i.e., single point in time). Programmatic performance of Cologuard (i.e., benefits and risks with repeated testing over an established period of time) has not been studied. Performance has not been evaluated in adults who have been previously tested with Cologuard. Non-inferiority or superiority of Cologuard programmatic sensitivity as compared to other recommended screening methods for CRC and AA has not been established. CRC screening guideline recommendations vary for persons over the age of 75. The decision to screen persons over the age of 75 should be made on an individualized basis in consultation with a healthcare provider. Cologuard test results should be interpreted with caution in older patients as the rate of false positive results increases with age. A negative Cologuard test result does not guarantee absence of cancer or advanced adenoma. Patients with a negative Cologuard test result should be advised to continue participating in a colorectal cancer screening program with another recommended screening method. The screening interval for this follow-up has not been established. Cologuard may produce false negative or false positive results. A false positive result occurs when Cologuard produces a positive result, even though a colonoscopy will not find cancer or precancerous polyps. A false negative result occurs when Cologuard does not detect a precancerous polyp or colorectal cancer even when a colonoscopy identifies the positive result. Patients should not provide a sample for Cologuard if they have diarrhea or if they have blood in their urine or stool (e.g., from bleeding hemorrhoids, bleeding cuts or wounds on their hands, rectal bleeding, or menstruation). To ensure the integrity of the sample, the laboratory must receive the patient specimens within 72 hours of collection. Patients should send stool samples to the laboratory according to the instructions stated in the Cologuard Patient Guide. Patients should be advised of the caution listed in the Cologuard Patient Guide. Patients should NOT drink the preservative liquid. The risks related to using the Cologuard Collection Kit are low, with no serious adverse events reported among people in a clinical trial. Patients should be careful when opening and closing the lids to avoid the risk of hand strain.

35

Cologuard Warnings and Precautions Prescribers of this test should be very familiar with these warnings and precautions

Final recommendations

• Compliant informed patients– colonoscopy for vast majority. • High risk patients– colonoscopy • Patients refusing colonoscopy – FIT, Cologuard, CT colonography, Barium enema, or Flexible sigmoidoscopy.

Handle Positive/Abnormal Findings • FIT or cologuard positive results – refer for colonoscopy So ask your patients if they want to prevent a colon cancer from forming? which is what colonoscopy has been shown to do. • Removing precancerous polyps reduces the risk of developing colon cancer. (90%) • There has been a reduction in the incidence of colon cancer since colonoscopy

has been implemented. Likely by identifying precancerous polyps • Colon cancer is unique among the common cancers in that there is a precursor

lesion that is readily identifiable and can be eliminated. THE POLYP. • FIT and cologuard do not take advantage of that benefit.

“90-90 rule”

Colonoscopy reduces colon cancer by 90%

Cologuard/FIT detects 90% of colon cancer

Conclusion

THANK YOU!