COLORECTAL CANCER SCREENING &THE FECAL IMMUNOCHEMICAL TEST (FIT) MATHEW ESTEY, PHD, FCACB CLINICAL CHEMIST

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COLORECTAL CANCER SCREENING &THE FECAL IMMUNOCHEMICAL TEST (FIT) MATHEW ESTEY, PHD, FCACB CLINICAL CHEMIST MATHEW.ESTEY@DYNALIFEDX.COM

FACULTY /PRESENTER DISCLOSURE FACULTY: MATHEW ESTEY RELATIONSHIPS WITH COMMERCIAL INTERESTS: GRANTS/RESEARCH SUPPORT: NONE TO DISCLOSE SPEAKERS BUREAU/HONORARIA: NONE TO DISCLOSE CONSULTING FEES: NONE TO DISCLOSE OTHER: EMPLOYEE OF DYNALIFE DX DIAGNOSTIC LABORATORIES

DISCLOSURE OF COMMERCIAL SUPPORT THIS PROGRAM HAS RECEIVED FINANCIAL SUPPORT FROM DYNALIFEDX IN THE FORM OF EDUCATIONAL PROGRAM THIS PROGRAM HAS RECEIVED IN-KIND SUPPORT FROM DYNALIFEDX IN THE FORM OF LOGISTICAL SUPPORT POTENTIAL FOR CONFLICT(S} OF INTEREST: MATHEW ESTEY HAS RECEIVED NO HONORARIUM AND IS IN EMPLOYED BY DYNALIFEDX. DYNALIFEDX PROVIDES LABORATORY SERVICES WHICH WILL BE DISCUSSED IN THIS PROGRAM.

MITIGATING POTENTIAL BIAS DYNALIFEDX OPERATES IN ACCORDANCE WITH ALBERTA HEALTH SERVICES, TESTING AND SOLUTIONS ARE A DIRECT RESULT OF PROVINCIAL STANDARDS.

LEARNING OBJECTIVES AT THE CONCLUSION OF THIS SESSION, PARTICIPANTS SHOULD BE ABLE TO: 1. COMPARE AND CONTRAST METHODS FOR DETECTING OCCULT BLOOD (FOBT VS. FIT) 2. DESCRIBE THE TOP GUIDELINES FOR COLORECTAL CANCER SCREENING IN ALBERTA 3. DISTINGUISH APPROPRIATE AND INAPPROPRIATE USE OF THE FECAL IMMUNOCHEMICAL TEST (FIT)

PRESENTATION OUTLINE COLORECTAL CANCER AND SCREENING OPTIONS COMPARISON OF FOBT AND FIT TOP COLORECTAL CANCER SCREENING CLINICAL PRACTICE GUIDELINES FIT FAQ

COLORECTAL CANCER SCREENING Colorectal cancer accounted for 12-14% of new cancer cases in Canada Incidence has been declining since 2000 Lifetime probability of developing colorectal cancer in Canada: 1:13 (M) 1:15 (F) CRC is the second leading cause of cancerrelated deaths in Canadian males, third cause in females

SCREENING MODALITIES ENDOSCOPY COLONOSCOPY SIGMOIDOSCOPY (DISTAL COLON ONLY) IMAGING (CT COLONOGRAPHY) DETECTION OF OCCULT BLOOD IN THE STOOL FECAL OCCULT BLOOD (FOBT) THE OLD FECAL IMMUNOCHEMICAL TEST (FIT) THE NEW

HOW CAN BLOOD BE DETECTED IN THE FECES? GLOBIN HEME Illustration from Anatomy & Physiology, Connexions Web site. http://cnx.org/content/col11496/1.6/ by OpenStax College is licensed under CC-BY-3.0 and obtained via Wikimedia Commons. Modified: background and text removed

FOBT FIT Guaiac + reagents Guaiac http://www.intelihealth.com/article/fecal-occult-blood-test

FOBT FIT Substance detected Heme group Globin protein Analytical method Color-change reaction due to Antibody-based peroxidase activity of heme Patient preparation Avoid: Peroxidase-containing foods and red meat Vitamin C Iatrogenic causes of GI bleeding (NSAIDs) None Sample Required 3 days of stool collection 3 cards submitted Single bowel movement Single vial submitted Definition of a positive result 1 or more samples produce a color change Compliance Poor Good Concentration of globin in stool/buffer mixture is above the cut-off of 75 ng/ml

FIT DIAGNOSTIC PERFORMANCE 79% 94% Lee at al. Ann Intern Med 2014. 160:171-810

Average risk individuals are those without a family/personal history of CRC or high-risk conditions http://www.topalbertadoctors.org/cpgs/30429617

http://www.topalbertadoctors.org/cpgs/30429617

FIT is acceptable for screening of: Average risk asymptomatic individuals aged 50-74 Patients aged 40-49 due to increased risk of CRC (1 st degree relative >60 at diagnosis) Patients aged 75-84 after quality of life and life expectancy have been assessed **FIT kits will no longer be provided to individuals outside the ages of 40-84**

FIT FAQ #1: CAN THE FIT BE USED FOR REASONS OTHER THAN COLORECTAL CANCER SCREENING? ANSWER: NO REASONS: FIT DOES NOT DETECT BLOOD FROM THE UPPER GI TRACT (GLOBIN DEGRADED) CUTOFF DESIGNED TO IDENTIFY THOSE AT INCREASED RISK OF COLON ADENOMAS/CANCER THE FIT RESULT WILL NOT ANSWER YOUR QUESTION!

FIT FAQ #1: CAN THE FIT BE USED FOR REASONS OTHER THAN COLORECTAL CANCER SCREENING? USING THE FIT AS A DIAGNOSTIC TOOL IN SYMPTOMATIC PATIENTS IS NOT EVIDENCE BASED UNNECESSARY AND CONSEQUENTIAL DELAYS IN WORK-UP COMMON INAPPROPRIATE USE OF FIT ANEMIA AHS Laboratory Bulletin, 2014 SUSPICION OF GI BLEEDING CHANGED BOWEL HABITS **Follow GI referral guidelines in these instances**

http://www.albertahealthservices.ca/ assets/info/hp/arp/if-hp-arp-adultgastroenterology.pdf

FIT FAQ #2: CAN THE FIT BE USED IN PATIENTS <40 YEARS? ANSWER: NO REASONS: SYMPTOMATIC PATIENTS FIT NOT INDICATED (SEE PREVIOUS 3 SLIDES) ASYMPTOMATIC PATIENTS INCIDENCE OF CRC IS LOW BELOW AGE 40 http://www.topalbertadoctors.org/cpgs/30429617

FIT FAQ #3: CAN THE FIT BE USED IN PATIENTS 85 YEARS? ANSWER: NO REASONS: RISK FROM COLONOSCOPY INCREASES WITH AGE AND CO- MORBIDITIES RISKS OUTWEIGH THE BENEFITS IN THIS AGE GROUP http://www.topalbertadoctors.org/cpgs/30429617

Avoid colorectal cancer screening tests on asymptomatic patients with a life expectancy of less than 10 years and no family or personal history of colorectal neoplasia Screening and surveillance modalities are inappropriate when the risks exceed the benefit. The risk of colonoscopy increases with increasing age and comorbidities. http://www.choosingwiselycanada.org/recommendations/general-surgery/

KEY POINTS FIT OFFERS SEVERAL ADVANTAGES OVER FOBT PATIENT: NO DIETARY / MEDICATION RESTRICTIONS, SIMPLER COLLECTION CLINICAL: HIGHER SENSITIVITY AND DIAGNOSTIC ACCURACY, INCREASED COMPLIANCE TOP CRC SCREENING CLINICAL PRACTICE GUIDELINES SCREEN ASYMPTOMATIC AVERAGE RISK INDIVIDUALS (50-74) WITH THE FIT TESTING ACCEPTABLE IN PATIENTS 40-49 IF INCREASED RISK OF CRC TESTING ACCEPTABLE IN PATIENTS 75-84 AFTER QOL AND LIFE EXPECTANCY ASSESSMENT

KEY POINTS APPROPRIATE UTILIZATION OF THE FIT SHOULD ONLY BE USED FOR CRC SCREENING PURPOSES INAPPROPRIATE UTILIZATION OF THE FIT SYMPTOMATIC PATIENTS (ANEMIA, CHANGE IN BOWEL HABITS, SUSPICION OF GI BLEED) PATIENTS <40 OR >85