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Colorectal Cancer Screening: What You Need to Know!

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Speaker: Dr. Dennis Ahnen

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Speaker:Dr. Ahnen completed his Medical School Training at Wayne State University in Detroit, Michigan and completed a Medical Residency and Chief Residency at Hutzel Hospital in Detroit before going to the University of Colorado as a Fellow in Gastroenterology in1977. After completing his Fellowship, he completed a Membrane Pathobiology Research Fellowship at Stanford University before returning to join the faculty of the University of Colorado School of Medicine in 1982 where he is currently a Professor of Medicine. In 2014, he retired from his long-standing (32 years) faculty position at The Department of Veterans Affairs Eastern Colorado Health Care System and joined the staff of Gastroenterology of the Rockies. Dr. Ahnen is an active clinician and investigator. He is the Co-Director of the University of Colorado Hereditary Cancer Clinic and founded the GI Clinic at Gastroenterology of the Rockies; he provides consultative service to GI cancer families in both settings. Dr. Ahnen is currently working to implement CRC prevention interventions that have been shown to be effective in clinical trials into a community-based practice of Gastroenterology.

Update on USPSTF Guidelines- 2016Dennis J. Ahnen MDDirector, Genetics ClinicGastroenterology of the RockiesProfessor of Medicine,University of Colorado School of Medicine

Update on USPSTF Guidelines- 2016Why is CRC screening important?What is the USPSTF and why is it important?Process of guideline developmentDescribe the 2016 guidelinesHow they differ from previous version (2008)Highlight potential controversiesInteresting caveats (at least to me)What do they mean to patients/families/providers/institutions

CRC is Common and Lethal

LungCRC

49,700 Breast ProstateLungCRC

132,700

OtherOther Prostate Breast

Pancreas

New Cases- 1,658,370 Deaths- 577,190

The Good News

IncidenceMenWomenMortalityWomenMen

CRC per 100,000

Screening Rate (%)IncidenceMortalityOverall ScreeningLower Endoscopy

Adapted from Patel SG, Ahnen DJ. Epi Stud Cancer Prev & Screening. 2013. 79(16):233-61.CRC Time Trends

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NormalepitheliumAbnormalepithelium

SmalladenomaLargeadenomaColoncarcinoma

10-15 YearsThe Adenoma Carcinoma Sequence

The Adenoma Carcinoma Sequence

NormalepitheliumSmalladenomaLargeadenomaColoncarcinoma

Prevention- Risk Factors Endoscopic Polypectomy

Early DetectionStool Tests

ColoGuard

The Adenoma Carcinoma Sequence

NormalepitheliumSmalladenomaLargeadenomaColoncarcinoma

Prevention- Risk Factors Endoscopic Polypectomy

Early DetectionStool Tests

CT Colonography

What is USPSTF Independent panel created by Congress in 1984Purpose- develop evidence-based recommendations about clinical preventive servicesSupported since 1988 byAHRQ- Agency for Healthcare Research and QualityEPC- Evidence-based practice center 16 volunteers- Preventive Med and Primary Care appointed by AHRQ director with TF inputExpressly prohibited from using cost

What is USPSTF Process Topics can be suggested by anyone; prioritized by TFTF and AHRQ- Evidence based practice center (EPC) drafts a research plan, public comment, finalEPC- gathers, reviews, analyzes data; reviews with TFTF commissioned report from CISNET CRC Working Working Group- start/stop age, screening intervals TF drafts recommendations, public comment, final.Post and publish final recommendations and evidence reviewAnnual Report to Congress

USPSTF Recommendations

Why are USPSTF Recommendations Important? Highly respected Minimal biasRigorous scientific reviewStructured process A and B recommendations- covered with no cost-sharing by ACALooked to by CMS, HEDIS and private insurers

2008 USPSTF CRC Screening Recommendations

The USPSTF recommends screening for CRC using fecal occult blood testing, sigmoidoscopy, or colonoscopy in adults age 50-75. The risks and benefits of the methods vary (A recommendation)Recommends against routine screening in adults 76-85 but there may be exceptions (C recommendation)Recommends against screening in adults older than 85 (D recommendation)Insufficient evidence to assess CTC and fecal DNA testing (I statement)

2016 USPSTF Screening GuidelinesThe USPSTF recommends screening for colorectal cancer starting at age 50 years and continuing until age 75 (A recommendation). Screening for CRC is a substantially underutilizedMultiple screening strategies are available to choose from, with different levels of evidence to support their effectiveness, as well as unique advantages and limitations, although there are no empirical data to demonstrate that any of the reviewed strategies provide a greater net benefit. See text and table for discussion.

2016 USPSTF Screening GuidelinesThe decision to screen for colorectal cancer in adults aged 76 to 85 years should be an individual one, taking into account the patients overall health and prior screening history (C recommendation)

2016 USPSTF Screening Guidelines

TestBiggest StrengthsBiggest LimitationsHsFOBTEffective and Non-InvasiveLow Cost3-day sampleRepeated annuallyFITEffective and Non-InvasiveLow CostRepeated annuallyVariable qualityFIT-DNAEffective and Non-InvasiveDetects some adenomasExpensive, Concern FPsInterval UncertainLimited DatasetFlex-Sig+/- FOBTEffective RCTsPainfulUnavailableColonoscopyVery effectiveDetects adenomasTherapeuticVery expensivePrepRisk of harmVariable qualityCT ColonographyVery effective, Less invasiveNo sedationDetects advanced adenomasNot therapeutic, PrepConcern over radiation/and unexpected findingsLimited Dataset/var qual

CISNET Microsimulation Modeling

Benefit Same graph if LYG/ 1000 screened used as measure of benefit

Burden

Harm

Important Issues and/or Interesting Caveats Cannot use cost as a factor in recommendationsPrimary endpoint of models CRC mortality not incidence Assumes 100% complianceApplies only to asymptomatic, average-risk populationDoesnt address other preventive measuresModeling data was used selectively (unavoidable?)Used totally for stopping ageUsed for FS q 10 yr + annual FOBT recommendation; cited one RCT that didnt make that conclusionDidnt use for recommendation about starting age

Modeling of Starting AgeModeling suggest that starting CRC screening at age 45 rather than 50 is estimated to yield a modest increase in life-years gained and a more efficient balance between life-years gained and lifetime number of colonoscopies. However, across the different screening methods, starting at age 45 while maintaning the same screening interval resulted in an estimated increase in the liftime number of colonoscopies.In the case of screening colonoscopy, 2 of the 3 models found that by starting screening at age 45, the screening could be extended from 10 to 15 years. Doing so maintained the same (or slightly more) life-years gained as performing colonoscopy every 10 years starting at age 50 years without increasing the lifetime number of colonoscopies. but. 1 model estimated a slight loss in life-years gained

Why the Fuss? No direct guidance on which test(s) to choose despite different levels of evidence, risks and benefits

Audio

No color contrast in their dull moralityThe shades of good and bad are throughNo distinction for right or wrongThey tell me any choice will do

And I'm black and white in a grey worldBlack and white in a grey world

Leslie Phillips - Black & White In A Grey World

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Why the Fuss? No direct guidance on which test(s) to choose despite different levels of evidence, risks and benefits Contrasts with 2008 guidelines as well as with USMSTF and many individual society guidelinesHeavy reliance on predictive modeling (CISNET)Totally for age to stop Only modeled for mortality outcome, not incidencePushback by organizations that prefer alternative approaches, often for good reason

Other Recommendations

ACS/USMSTF/ACR- includes all but.. tests that detect adenomas as well as CRC preferredTests that detect adenomas and cancer: FS, Colonoscopy, DCBE, CTCTests that primarily detect cancer: HsFobt, Fit, Fecal DNAGI Societies- ACG/ASGE- colonoscopy preferred

Screening TestUSPSTFMSTFHigh Sens FOBT annualYesYesFlex Sig q 5 yr +/- interval FOBT YesYesColonoscopy q 10 yrYesYesCT Colonography q 5 yrNoYesStool DNA NoYes

Recommendations 2008

Screening TestUSPSTFMSTFHigh Sens FOBT annualYesYesFlex Sig q 5 yrYesYes*Flex Sig q 10 yr +Annual HsFOBT YesNoColonoscopy q 10 yrYesYes*CT Colonography q 5 yrYesYes*Stool DNA YesYes

Recommendations 2016

ResponsesAGA- While the potential of each program to prevent CRC death is presented in the decision model, the potential to reduce incidence is not discussed.Unfortunately, USPSTF was silent on the importance of patient adherence and test quality.

ResponsesWhile ACG agrees that there is much to be done to increase colorectal cancer screening rates in the United States, the College is concerned that the USPSTFs approach leaves patients, physicians and payers in a quandary.

distinction between screening strategies that prevent colorectal cancer versus strategies that detect colorectal cancer. The ACG endorses high-quality colonoscopy as the colorectal cancer screening test of choice

ResponsesASGE- Patients and referring physicians need to be aware that all positive and false positive screening tests will need to be followed up with a colonoscopy. Under current Medicare policy, the colonoscopy will then be considered a diagnostic examination, requiring the patient to pay a deductible and coinsurance.

No other screening test approaches the sensitivity of colonoscopy for detection of polyps. ASGE maintains that colonoscopy is the gold standard for colorectal cancer screening.

What did these folks have to say?

Including more strategies has the potential to increase the number of people screened for colorectal cancer. But..We would suggest adding, in detail, the prioritization and indications for use to aid in decision making

Recommend-Further evaluation of the existing modeling studies, specifically looking at those 45-50 years old. USPSTF consider commissioning a specific modeling study using current incidence and mortality data in the 45-50-year-old cohort as a whole and in the African American and Native American sub-populations.

What does it mean for patients?

More options available and covered by insuranceA test for any patient and any institutionCan tailor testing to desire of patientPotential for more confusion/uncertaintyNot much different from current situationDependent on how provider approaches itMay see more direct to consumer advertisementAny option is a good one if it gets done well

What does it mean for provider?

More options available and covered by insuranceA test for any patient and any institutionMore options for patients who do not want colonoscopyCan tailor testing to clinical settingPotential for more confusion/uncertaintyNot much different from current situationProviders use one or more of these approachesWill see increased marketing effortsIncreases quality control issues

What does it mean for practice/institution?

Monitor HEDIS performanceAdd new options for CRC screeningChange acceptable intervalsMonitor CRC screening ratesDittoRe-think institutional CRC screening strategyWill see increased marketingIncreases quality control issues

How to interpret the guidelines?

An honest systematic analysis and synthesis of the data that focuses on mortality, not incidenceSeveral good options that are all similarly effective if compliance is assumed to be 100% Compliance >> EffectivenessChoose the right test for the patientSetting, Resources, Health Status, DesireThe best test is still the one that gets done.And done well...

Opportunities For Us

Advocate and Educate about importance of Compliance and qualitySymptoms, FH and genetic syndromesDiscussing screening by age 40 or earlierAdvocate For or better yet FundExamination of existing CISNET data for 45-50 year olds and for African Americans and Native Americans New modeling studies in young adultsGerm line and tumor molecular studies in CRC under age 50

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Contact Us!

Black and White In a Grey WorldLeslie PhillipsLeslie PhillipsBlack and White In a Grey WorldChristian & Gospel1985-01-01T08:00:00Zsharyn.f.g@gmail.com 1985 Word Incorporated2016-09-12 17:46:37Warner:isrc:USWR60400274