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A Call to Action: Prevention and Early Detection of Colorectal Cancer (CRC) 5 Key Messages Screening reduces mortality from CRC All persons aged 50 years and older should begin regular screening High-risk individuals may need to begin screening earlier Colorectal cancer can be prevented Several effective screening options are available; not screening is no longer an option Burden of Disease Second leading cause of cancer death in US American Cancer Society estimates in 2000: 130,200 new cases 56,300 deaths Both women and men All races Number/100,000 Who Is at Risk? 600 500 400 300 200 100 0 Cancers of the Colon and Rectum: Average Annual Age-Specific SEER Incidence and U.S. Mortality Rates By Gender, 1992-1996 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85+ Age Group Source: Cancer Statistics Review, 1973-1996, SEER, NCI. Incidence Male Incidence Female Mortality Male Mortality Female Colorectal Cancer (CRC) Sporadic (average risk) (65% 85%) Rare syndromes (<0.1%) Familial adenomatous polyposis (FAP) (1%) Family history (10% 30%) Hereditary nonpolyposis colorectal cancer (HNPCC) (5%) 1

Natural History Screening = Prevention + Early Detection Polyp Advanced bleeding cancer Prevention (polyp removal) decreased incidence Early detection decreased mortality Evidence for Screening FOBT Fecal Occult Blood Test (FOBT) Flexible sigmoidoscopy FOBT + flexible sigmoidoscopy Double-contrast barium enema (DCBE) Colonoscopy Office FOBT after digital rectal exam (not recommended) FOBT Trials Minn Minn UK Denmark Frequency of testing Annual Biennial Biennial Biennial Duration (years) 18 18 8 10 Hydration of slides Yes Yes No No % requiring colonoscopy 30% 30% 5% 5% Digital Rectal Exam Office FOBT after digital rectal exam not recommended as a stand-alone test Sensitivity and specificity are lower than at-home FOBT Digital rectal exam not recommended as a stand-alone test Mortality reduction 33% 21% 15% 18% 2

Flexible Sigmoidoscopy Diagram of the Colon and Rectum Splenic flexure Fiberoptic sigmoidoscope Flexible Sigmoidoscopy Case-control study (Selby et al. 1992) 60% reduction in deaths from colorectal cancers within reach of the sigmoidoscope No reduction in deaths from proximal cancers FOBT + Flex Sig No direct evidence about the combination of the two tests Use of two independent tests potentially increases detection DCBE No prospective trials of DCBE screening Colonoscopy Most accurate test for detection of polyps and colorectal cancer No prospective trials of screening colonoscopy Several randomized trials are ongoing National Polyp Study supports the effectiveness of removing polyps to prevent colorectal cancer 3

Colorectal Cancer Screening Is Cost-Effective Office of Technology Assessment, US Congress, April 1995 All screening strategies below an accepted benchmark value of $40,000/added year of life Concluded CRC screening is a good societal investment Cost-Effectiveness (Cost/Year Life Saved) Mandatory motorcycle helmets $2,000 Colorectal cancer screening $25,000 Breast cancer screening $35,000 Dual airbags in cars $120,000 Smoke detectors in homes $210,000 School bus seat belts $1,800,000 (Slide courtesy John Bond, M.D.) Colorectal Screening Rates Low: 1997 Survey of >50,000 Adults Subjects Reporting Ever completed FOBT (Age 50) Up to date 20% (1 yr) Flex Sig (Age 50) Mammography (Age 40) 40% 42% 85% 30% (5 yrs) 71% (2 yrs) When Not To Screen Don t apply screening guidelines to symptomatic patients Screening patients with terminal illness is unwarranted Benefits of polyp detection decrease with advanced age Source: Behavioral Risk Factor Surveillance System, 1997 Factors to Consider in Choosing a Strategy Patient s colorectal cancer risk Implementation issues Adverse effects Patient s preferences Assessing Individual Risk Increased risk: personal history of colorectal cancer or polyps family history of colorectal cancer or polyps inflammatory bowel disease certain inherited cancer syndromes signs/symptoms rectal bleeding iron deficiency anemia 4

Assessing Individual Risk (continued) Average Risk: Everyone Else 50 and Over Screening Options for Average-Risk Individuals FOBT alone every year Flex sig alone every 5 years FOBT every year + flex sig every 5 years DCBE every 5 to 10 years Colonoscopy every 10 years All national guidelines include some combination of these options Overarching Implementation and Counseling Issues Benefits and adverse effects Patient education materials Insurance coverage information Explicit policy and mechanisms for follow-up Potential Adverse Effects Vasovagal syncope Perforation Hemorrhage Death Estimated Costs of Colorectal Cancer Screening Options FOBT $10 $25 Flexible sigmoidoscopy $150 $300 Colonoscopy $800 $1600 DCBE $250 $500 FOBT How it works Detects blood from any GI source Rehydration Preparation Dietary/medication restrictions Periodicity Annual testing most effective 5

FOBT (continued) Provider capacity Special training not required Patient adherence Patient education is critical Follow-up Positive FOBT requires total colon exam After a negative total colon exam, suspend annual FOBT for 5 to 10 years Negative FOBT requires repeat FOBT in 1 year To Begin a Home FOBT Screening Program You will need FOBT card kits Assigned roles for office staff Instructing and encouraging patients Developing cards Recording results Notifying patient and clinician FOBT Counseling Your Patients Explain exactly what to do Don t rely solely on instructions in kit Consider using a reminder system to increase adherence Flex Sig How it works Provides direct view of distal portion of the colon Preparation 2 enemas Periodicity Every 5 years Provider capacity Training and referral Flex Sig (continued) Patient adherence Provider recommendation leads to high patient acceptance Follow-up 5% to 15% will have a positive result Positive result requires total colon exam To biopsy or not? Which provider? Which lesions? Negative result requires repeat flex sig in 5 years To Begin an Office Flexible Sigmoidoscopy Screening Program You will need Trained clinician(s) Equipment Light source Suction device Flexible sigmoidoscope Videoscreen preferable Procedure room with bathroom nearby Assigned roles for office staff Patient scheduling and instruction Equipment setup, cleaning, and maintenance Assistance with procedure Informed consent policy 6

To Begin a Program of Referring to Another Facility for Flexible Sigmoidoscopy or Colonoscopy You will need Identified partner site Mechanism for direct referral for the procedure Includes pre-procedure testing and risk assessment Flex Sig Counseling Your Patients Expect moderate discomfort (like gas pain) Most patients report that it s not as bad as they thought it would be Sedation not routinely used Exam lasts approximately 20 minutes Patients able to return to work and don t need a ride DCBE How it works Provides x-ray image of the colon Preparation Clear liquids Laxatives and enemas Periodicity Every 5 to 10 years Provider capacity Widely available but quality inconsistent DCBE (continued) Patient adherence Unknown adherence rates Follow-up 5% to 15% will have a positive result Positive result requires follow-up test, usually colonoscopy Negative result requires repeat DCBE every 5 to 10 years To Begin a Barium Enema Screening Program You will need Identified experienced radiology site Assigned tasks for office staff Patient education Scheduling DCBE Counseling Your Patients Expect moderate discomfort Requires patient to change position during exam Sedation is not used Exam lasts about 20 to 30 minutes Patient could return to work but will have frequent barium stools or constipation 7

Colonoscopy How it works One-step screening/treatment procedure Provides direct view of entire colon Preparation Clear liquids Osmotic laxative Enema Sedation routinely used Colonoscopy (continued) Periodicity Every 10 years Provider capacity Training and referral Patient adherence Feasibility trials beginning Colonoscopy (continued) Follow-up Positive result frequently treated during screening exam Negative result requires repeat colonoscopy in 10 years Colonoscopy Counseling Your Patients Expect moderate discomfort with preparation, but actual procedure performed under sedation Some patients experience discomfort during recovery Exam lasts approximately 30 to 45 minutes Patient requires ride home after procedure and usually is off work that day Current Issues and Future Directions Shared Decision Making vs. Provider-Directed Choice Reimbursement HEDIS Ongoing randomized trials Virtual colonoscopy 8

Current Issues and Future Directions (continued) National Colorectal Cancer Roundtable Public awareness campaigns Capacity Primary Prevention of Colorectal Cancer Exercise Low-fat diet rich in fruits and vegetables Fiber? Chemoprophylaxis NSAIDs Calcium Estrogen Folate Selenium A Call to Action Screening reduces mortality from CRC All persons aged 50 years and older should begin regular screening High-risk individuals may need to begin screening earlier Colorectal cancer can be prevented Several effective screening options are available; not screening is no longer an option 9