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Colon Cancer Screening for Primary Care Physicians. Richard C. Wender, MD Alumni Professor and Chair Department of Family & Community Medicine Thomas Jefferson University Past President, American Cancer Society. What We’ll Cover. Epidemiology Screening Trends New Guidelines
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Colon Cancer Screening for Primary Care Physicians Richard C. Wender, MD Alumni Professor and Chair Department of Family & Community Medicine Thomas Jefferson University Past President, American Cancer Society
What We’ll Cover • Epidemiology • Screening Trends • New Guidelines • Improving preventive practice • Organizing your office • Improving quality and screening rates
Colon Cancer: Epidemiology • 108,070 cases predicted in 2008 • 49,960 deaths expected • Death rates declining by 4.7% per year from 2002-2004 Cancer Facts and Figures, 2008. American Cancer Society
CRC Screening: Rates Are Rising . . . Probably • NHIS data based on self report • Screening exceeding 60% in many states • 70% in Connecticut • HEDIS data based on claims and chart reviews • 55% in commercial and rising • 53% in Medicare and flat
Understanding Screening Rate Trends • With shift to colonoscopy as predominant modality, shouldn’t all rates be going up? • Perhaps abandonment of FOBT and FIT is negatively impacting rates • Hard to reach everyone with colonoscopy
Understanding Screening Rate Trends Annual FOBT/FIT: People coming in and out of being “up to date” every year Colonoscopy: Key driver of gradual increase in “up to date” status
New Guideline Methodology • Guidelines were developed by a consensus group representing: • American Cancer Society • American College of Radiology • Multi-Society GI Task Force • American College of Gastroenterology • American Gastroenterological Association • American Society for Gastrointestinal Endoscopy
CRC Screening Guidelines: New Concepts • A 50% sensitivity threshold for cancer • Tests that predominantly target prevention versus tests that predominantly target cancer
“It is the strong opinion of this expert panel that colon cancer prevention should be the primary goal of CRC screening” Screening and Surveillance for the Early Detection of Colorectal Cancer and Adenomatous Polyps, 2008
Tests That Primarily Detect Cancer • Annual gFOBT with at least 50% test sensitivity for cancer, or… • Annual FIT with at least 50% test sensitivity for cancer, or… • sDNA at uncertain screening interval
U.S.P.S.T.F. Guidelines • Do not include DNA or C-T Colonography • Medicare has decided NOT to cover colography
Tests That Detect Adenomatous Polyps and Cancer • Flexible sigmoidoscopy every 5 years, or… • Colonoscopy every 10 years, or… • Double-contrast barium enema every 5 years, or… • CT colonography every 5 years
Colorectal Cancer Screening And Prevention • Do we still need a menu of options? • What new tests might be added to the menu? • Should colonoscopy be the preferred testing option? • What screening options might be dropped from the menu?
CRC Screening: Issue 1 Do we still need a menu of screening options?
A Screening Menu • We cannot yet abandon the menu • No one clearly superior test for all people • No one structural test that is available to all • No one test that will be accepted by all
CRC Screening: Issue 2 What new tests are added to the screening menu?
Fecal DNA Testing (PreGen-Plus) • Advantages: • Passes the 50% sensitivity threshold • DNA shedding unlikely to be intermittent • Doesn’t require stool handling • May not be necessary annually
Fecal DNA Testing • Disadvantages: • Sensitivity may be less than sensitive stool blood tests, particularly FIT • Requires mailing of a whole stool sample • Safe interval is not known • Expense: >$250 per test • 10 times more than FIT • Close to 100 times more than guiac FOBT
Fecal DNA Tests – An Update • Pre Gen Plus is up to its third generation of refined testing – Performance is reportedly better, but as yet unproven • Cost is coming down and may be as low as $300 • Testing interval reported by the company is 5 years Data supporting this interval is inadequate
DNA For Colon Cancer – Blood Tests • Several blood tests in clinical trials
Fecal DNA • A promising technology • Lots of studies demonstrating the ability to find abnormal DNA that is associated with cancer • BUT, some FIT studies have showed better sensitivity for cancer at far less cost. And the testing interval of 5 years seems long. 3 years or fewer may make more sense, but significantly increases the cost
C-T Colonography Issues • It’s NOT a virtual experience • Requires a prep • Requires air insufflation of the colon • Cost is high • AND colonoscopy is required for abnormal findings • To be an option, sensitivity and specificity must be outstanding
Will CT Colonography Become The Preferred First Line Screening for Colon Cancer? • Cheaper • Safer • Visualizes the whole colon • Requires the same prep • BUT is it accurate?
C-T vs. Colonoscopy: Sensitivities for All Polyps Polyp Size >10mm >8mm >6mm C-T 92.2% 92.6% 85.7% Colonoscopy 88.2% 89.5% 90.0%
What Percent of Patients Would Require Colonoscopy If C-T Were Done First? Polyp Size % Requiring Threshold Colonoscopy 10mm 7.5 8mm 13.5 6mm 29.7
Virtual colonoscopy identified 55 polyps not seen on initial colonoscopy • 21 were adenomatous • One 11mm malignant polyp
Non-Colonic Findings • 5 asymptomatic cancers • Aortic aneurysms • Renal and gall bladder calculi
Next Big C-T Colonograhy Study • Published in JAMA • Results were far less good than seen in the Pickardt study. Key factors were • Experience of the center • Time devoted to reading • Use of digital subtraction and fly- through technology
And The Next Big CT Study • The ACRIN study is a multi-center study with each site using the new technology • First results will be reported within 6 months
ACRIN Results – First Report • 15 center trial • 2,531 asymptomatic patients • Either 2D or 3D • Multiple manufacturers • Almost all had colonoscopy
ACRIN Results • 547 polyps detected in 390 patients • 2/3 were adenomas • Mean size was 8.9 mm • 128 polyps > 1 cm • 7 cancers detected
Will C-T Colonography Become A Mainstream Option? • Reasons to think that it will • Cheaper than colonoscopy as a single, one-time test • Excellent performance characteristics in experienced centers • Safer than colonoscopy
Will C-T Colonography Become A Mainstream Option? Reasons to think it will not: • Time consuming for radiologist • Few experienced centers exist today • Requires extensive training • Small polyps are ignored • Requiring shorter screening interval (every 5 years) • This impacts cost and capacity • If all polyps >6cm lead to colonoscopy, 3 to 5 CTC’s will lead to 1 colonoscopy
Should Colonoscopy Be The Preferred Screening Test? • Colonoscopy utilization is increasing dramatically • Sigmoidoscopy utilization is decreasing and barium enema is rarely utilized • Clinicians are still utilizing FOBT and FIT • Requires annual testing and rates of repeat testing are very low
Colonoscopy Preferred? • Colonoscopy is not a gold standard • Complications in 1/1000 exams • Misses from 5 to 10% of important lesions • But the key advantages are accuracy and ability to screen as infrequently as every 10 years • Our practice has decided to recommend colonoscopy as preferred strategy with a FIT test as a back-up
Colonoscopy Preferred?Hype May Exceed Reality • Annual FIT screening may be as effective as colonoscopy every 10 years • Hard to find evidence that mortality from right sided diseases is declining
What Tests Might Be Dropped From The Guidelines? • Lower sensitivity FOBT’s , such as Hemoccult II do not meet the 50% threshold and should be dropped from the guideline
Pearls In Cancer Screening: Colon Cancer • The FOBT done at the time of a digital rectal must be stopped • A negative result offers ZERO reassurance…or, even worse, false reassurance • A major national campaign is underway to stop this • Medicare will no longer pay • Few people do FOBT or FIT every year • A test that can be done less frequently is preferred for most
Bringing Quality To A Colonoscopy Screening Program • Characteristics of a high-quality screening program • Patient registry • Appointment made by PCC office staff, not the patient • Short wait time • Navigation through prep & reminder of date • High quality colonoscopy with standard reporting • Call-back reminder
Why focus on primary care practice? What can we do about it? • We have it in our power to improve the screening rate. ‘This is our sphere of influence.’ • 80-90% of people >age 50 saw 1°MD last year(BRFSS, CDC) • Few practices currently have mechanisms to assure that every eligible patient gets a recommendation for screening.
A physician’s recommendation is the most influential factor in cancer screening!