Colonoscopy Screening: Issues and Controversies Symposium on GI - - PowerPoint PPT Presentation

colonoscopy screening issues and controversies
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Colonoscopy Screening: Issues and Controversies Symposium on GI - - PowerPoint PPT Presentation

Colonoscopy Screening: Issues and Controversies Symposium on GI Cancers St. Louis 9-12-09 David Lieberman MD Chief, Division of Gastroenterology and Hepatology Oregon Health Sciences University Portland VAMC Risk Factors for CRC HNPCC


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SLIDE 1

Colonoscopy Screening: Issues and Controversies

Symposium on GI Cancers

  • St. Louis

9-12-09 David Lieberman MD Chief, Division of Gastroenterology and Hepatology Oregon Health Sciences University Portland VAMC

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SLIDE 2

Risk Factors for CRC

Sporadic/ Average Risk 75% IBD-1% Colitis Family History 15-20% HNPCC 3% FAP-1% World wide:

  • 1M new cases/yr
  • > 500,000 deaths/yr
  • 2nd leading cause
  • f cancer death

in USA

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SLIDE 3

Colorectal Cancer Screening

Normal Colon Advanced Adenoma

10-20% Lifetime Risk Genetic Environmental Lifestyle 5-6% Lifetime Risk

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SLIDE 4

Raising the bar

MD

Early Colon Cancer Detection Colon Cancer Prevention

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SLIDE 5

CRC Screening Guidelines 2008

Screening Test ACS-MSTF- ACR* USPSTF* ACG gFOBT YES; requires >50% sensitivity for CRC YES; “sensitive” test

  • nly

Yes; only sensitive test FIT YES; requires >50% sensitivity for CRC YES Preferred as cancer detection test Stool DNA YES; requires >50% sensitivity for CRC NO YES; every 3 years

  • ACS-MSFT-ACR = American Cancer Society; Multi-Society Task Force CRC;

American College of Radiology

  • USPSTF = United States Preventive Services Task Force
  • ACG = Am College of Gastroenterology

Tests which “primarily” detect early cancer:

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SLIDE 6

CRC Screening Guidelines 2008

Screening Test ACS-MSTF- ACR* USPSTF* ACG CT Colonography YES – every 5 years NO – insufficient evidence YES; every 5 years Flex Sig YES – every 5 years YES – every 5 years with sensitive FOBT YES; every 5-10 years

Colonoscopy

YES – every 10 years YES – every 10 years YES - preferred

ACS-MSFT-SCR = American Cancer Society; Multi-Society Task Force CRC; American College of Radiology USPSTF = United States Preventive Services Task Force; ACG = Am College of Gastroenterology

Tests which can detect early cancer and cancer precursor lesions

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SLIDE 7

Stool-Based Tests: Sensitivity

Test Cancer Advanced Adenoma Standard gFOBT 33-50% 11% Sensitive gFOBT 50-75% 20-25% FIT 60-85% 20-50% Stool DNA (old version) 51% 18% Stool DNA (new version) 80+% 40% Key new references: sDNA: Ahlquist et al; Ann Intern Med 2008; 149;441-50 FIT: Hundt et al; Ann Intern Med 2009; 150: 162-9

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SLIDE 8

Fecal Blood Tests

  • Complicated in real life
  • Requires programmatic

adherence with (+) and (-) tests

  • Programmatic performance:
  • Unlikely to result in

much cancer prevention UNKNOWN

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SLIDE 9

Structural Colon Exams: Sensitivity of one-time test

Test Cancer Advanced Adenoma CT Colonography (CTC) Uncertain; likely >90% 90% if >10mm 78% for all polyps >6mm Sigmoidoscopy >95% distal colon 60-70% Proximal colon 70% Colonoscopy >95% 88-98%

Key new references: CTC: Johnson et al; NEJM 2008; 359; 1207-17

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SLIDE 10

USA – Colorectal Screening

10 20 30 40 50 60 2000 2001 2002 2003 2004 2005

National Health Interview Survey Sigmoid FOBT

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SLIDE 11

Colonoscopy Screening Studies (n > 1000)

  • Studies: 2000-2004

– Lieberman et al; VA Cooperative Study ;NEJM: 2000; 343: 162-8 (n = 3121) – Indiana Study; NEJM 2000; 343: 169-74 (n = 1994) – CT Colonography studies (n = 2447) (Pickhardt, Rockey, Cotton) – Fecal DNA Study; NEJM 2004; 351: 2704-14 (n = 4404) – Spain, Am J Gastroenterol 2003; 98: 2648-54 (n = 2210)

  • Studies: 2005-2006

– Women: (Schoenfeld) NEJM 2005; 352: 2061-8 (n = 1463) – Taiwan; Gastrointest Endosc 2005; 61: 547-53 (n = 1708) – Japan, Gastroenterology 2005; 129: 422-8 (n = 21,805 with iFOBT) – Seattle, JAMA 2006; 295: 2357-65 (N = 1244) – Poland, NEJM 2006; 355: 1863-72 (n = 50,148)

  • Experience: 2007-2008

– Germany (n = > 2 million )

Results: 5-10% with Advanced Neoplasia 0.5-1.0% with Cancer

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SLIDE 12

Colonoscopy

  • Evidence:

– Cohort Studies: feasibility and safety – Case-Control Studies

Study Mortality Incidence Muller/Sonnenberg; 1995

  • OR = 0.47

Singh; 2006

  • After negative CSP:

5 yrs: SIR 0.55 10 yrs: SIR 0.28 Baxter; 2009 Left colon: OR 0.33 Right colon: OR 0.99 Kahi; 2009 SMR 0.35 SIR 0.33 Case- Control Cohort

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SLIDE 13

Colonoscopy

  • Quality in practice:
  • Program performance:
  • Potential for cancer prevention:

unknown unknown High

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SLIDE 14

Interval Cancer after Colonoscopy 0.3-0.9%

  • New, fast growing lesions

– Sawhney et al; Gastroenterology 2006; 131: 1700-5

  • Incomplete removal

– Pabby et al; Gastrointest Endosc 2005; 61: 385-91

  • Missed lesions

–2-12% of polyps >1cm are missed

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SLIDE 15

Colon Screening Issues

  • Flat polyps

Soetikno et al; JAMA 2008; Lieberman; JAMA 2008

Submucosal cancer Indigocarmine

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SLIDE 16

Colon Screening Issues

  • Case control Study: 10,292 cases

– CRC (any) : OR 0.63 (0.57-0.69) – Left colon: OR 0.33 (0.278-0.39)

– Proximal colon: OR 0.99 (0.86-1.14)

  • Why?

– Biology – Quality

Baxter et al; Ann Intern Med 2009; 150: 1-8

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SLIDE 17

Colonoscopy: Serious Adverse Events /1000

Setting Year n Bleed Perforation Other*

VACSP 380-13 centers Screening only; 30d f/u 2002 3196 1.9 1.0 * hospitalization Teaching Hosp Australia 2003 23,508 2 1

  • Amb Surg Centers

USA 2003 116,000

  • 0.3
  • Community-UK

2004 9223

  • 1.3
  • Medicare Sample

Age >65 yrs 2003 39,286

  • 2
  • Community

USA-Wisconsin 2006 12,407 2 0.16

  • HMO-USA

2006 16,318 3.2 0.9

  • Community-Poland

Screening only 2006 50148 0.26 0.1 0.7 * hospitalization Outpatient-Canada Claims data 2008 97,091 1.6 0.85

  • California Medicaid

Claims data 2009 277,434

  • 0.8
  • Manitoba; Claims data

30d f/u 2009 21,191 0.86 1.18 Medicare; Claims data 30d f/u 2009 53,220* 6.4 0.6 CV events with polypectomy

0.3-3.2 per 1000 0-1.3 per 1000

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SLIDE 18

Colon Cancer Screening: Colonoscopy

  • Appropriate utilization
  • High-quality exam to cecum
  • Low rate of missed lesions
  • Low rate of incompletely

removed lesions

  • Low rate of adverse events

QUALITY

Effectiveness depends on:

Rex, 2006 Lieberman et al; Gastrointest Endosc 2007; 65:757-66 Lieberman et al; Gastrointest Endosc 2009; 65: 757-66

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SLIDE 19

Colon Cancer: Incidence and Mortality

100 200 300 400 500 600 45-50 55-60 65-70 75-80

AGE per 100,000 Male Incidence Mortality Female

Does it make sense to screen women at the same age as men?

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SLIDE 20

CRC Screening: what is found?

% with Polyp(s) > 9mm

Lieberman et al, CGH 2005: 3: 798-805

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SLIDE 21

Number needed to endoscope: NNE

5 10 15 20 25 30 35 40 45 Male Female <50 50-59 60-69 70-79 >79

Asymptomatic Screening To identify one patient with polyp > 9mm

50 59 50 59

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SLIDE 22

CRC and Race/Ethnicity

Incidence Mortality Male Female Male Female White 58.9 43.2 22.1 15.3 Black 71.2 54.5 31.8 22.4 Asian 48.0 35.4 14.4 10.2 Hispanic 47.3 32.8 16.5 10.8 Native 46.0 41.2 20.5 14.2 ALL 59.2 43.8 22.7 15.9 Stage White Black Local 40% 35% Regional 37% 35% Distant 19% 24%

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SLIDE 23

Colorectal Cancer: Incidence Trends by Race

Source: American Cancer Society; 2008

Why?

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SLIDE 24

Black vs White Differences

  • Socio-economic

– Lack of access to health care – Lower insurance

  • MD-Patient

– Failure of MD to recommend screening – Failure of patient to accept screening

  • Cultural barriers
  • Biology
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SLIDE 25

Black vs White

1 2 3 4 5 6 7 8 9 10 <50 50-59 60-69 70-79 >79 ALL White Black

% with polyp (s) > 9mm

Lieberman et al; JAMA 2008; 300: 1417-22

2 4 6 8 10 12 14 16 18 < 50 50-59 60-69 70-79 >79 ALL White Black

Women: OR 1.62 (1.39-1.89) Men: OR 1.161.01,1.34

When barriers to screening are not an issue, asymptomatic black men and women are more likely to have polyp(s) >9mm compared to whites

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SLIDE 26

Colon Screening Issues

  • Are we ready for customized screening

based on :

– Sex – consider screening women later – Race – consider screening Blacks with colonoscopy, since they represent a high-risk group

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SLIDE 27

Colon Screening Issues

  • Stopping screening based on age

– No routine screening for adults 75-85 years – Against any screening after age 85 years

USPSTF; Ann Intern Med 2008; 149: 627-37 Lieberman et al, CGH 2005: 3: 798-805

100 200 300 400 500 600 45-50 55-60 65-70 75-80

Male Female

per 100,000 Incidence Mortality Polyp(s) >9mm

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SLIDE 28

10-Year Interval: Is it safe?

  • Missed lesions
  • Interval cancers
  • Lawsuits
  • Epidemiology
  • Case-control

studies

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SLIDE 29

Lessons from USA Experience

  • Colon Cancer Screening is effective
  • Prevention should be a primary goal
  • Obstacles to screening can be overcome:
  • Effectiveness of screening programs depends on

QUALITY and Adherence