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Falk SymposiumOctober 1, 2005
Impact of National Polyp Study
Sidney J. Winawer, M.D.Memorial Sloan-Kettering Cancer Center
New York, NY
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Diagnosis of Large Bowel Cancerin Asymptomatic Patients
Screening of Asx, PeopleIntermittent BleedingDietary ControlGuaiac Cards
David H. Greegor, MDColumbus, Ohio
JAMA Sept. 18, 1967
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Hirschowitz, 1950s
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Colonoscopyc. 1970
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Adenomatous Polyp
Shinya & Wolf, 1976
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Adenoma Burden from Screening
Adenomas Cancers
Flex Sigmoidoscopy 12% 0.3%
FOBT Pos. Pts. 27% 3%
Colonoscopy 18–36% 1%
Mandel, NEJM 1993; Atkin, Lancet 2002; Lieberman, NEJM, 2000.
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Post-Polypectomy Surveillance1970s
Common Practice:Annual Follow-up Colonoscopy
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Cori Data. Lieberman
Colonoscopy workloadabout 25% surveillance inpeople over 50 yrs. of age
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National Polyp Study
Randomized Trial
Surveillance Intervals
Surveillance Methods
CRC Incidence
Adenoma-Carcinoma Model
7 Clinical Centers
MSK Coord. Center
1980
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Colorectal Cancer Incidence in NPS Following Colonoscopic Polypectomy
(1418 pts; 8401 person yrs)
Winawer, Zauber et al. 1993. NEJM 329:1977-81
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National Polyp StudyAdvanced Adenomas at Follow-Up
3%
32%
R
3%
1 year 3 year
Winawer, Zauber et al. NEJM 1993.
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U.S. Colorectal Cancer Screening Guidelines
Consensus
U.S. Preventive Services Task Force 1996
GI Consortium 1997
American Cancer Society 1997
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SCREENING GUIDELINES
Screening Colonoscopy q 10 Yearsfor Average Risk Men and Women
Colorectal cancer screening clinical guidelines and rationale. Winawer, Fletcher, et al., GE, 1997ACS colorectal screening guidelines. Byers, Levin et al., CA, 1997
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NPSColonoscopy/Barium Enema
ComparisonBlinded/Unblinded Method
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Comparison of DCBE & Colonoscopy*
862 Paired Exams in 580 Pts.
DCBE Detection 48% for Adenomas >1 cm
*Winawer, Zauber et al, NEJM 2000
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Virtual Colonoscopy
Pickhardt et al. NEJM 2003
Cohort: 1223 Asx
Designs: Blinded V.C. vs. Co.
V.C. vs. Co.: Equivalent
V.C. Sensitivity: 94% for Adenomas ≥ 8 mm
Method: Initial 3D, Electronic Cleansing
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1380-4*Zauber, Winawer et al, GE 1997
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Post-Polypectomy SurveillancePo
lype
ctom
y IncreasedRisk
LowerRisk
30%
70%3 yr
5 yr
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New GuidelinesProcess
U.S. Multisociety Colorectal Cancer Task Force
American Cancer Society
Systematic Literature Search
Predictors of Advanced Adenomas
Risk Stratification
Advanced Adenomas: >1 cm or villous featuresor high grade dysplasia
US Multisociety Taskforce & ACS, 2005
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Predictors of Riskfor Advanced Adenomas
US Multisociety Taskforce & ACS, 2005
Multiplicity (> 3 Adn)Size (> 1 cm)Villous FeaturesHGD
Increased Risk
1 or 2 adenomasSize (< 1 cm)No Villous FeaturesNo HGD
Lower Risk
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Recommendations forFollow-up Colonoscopy
3–10 adenomas, or anyadvanced adenoma 3 yrs>10 adenomas < 3 yrsPiecemeal or incomplete 2–6 monthsHNPCC Intensive F/U (1–2 yrs)
Increased Risk
1 or 2 <1 cm TA & LGD 5–10 yrsHyperplastic Polyps 10 yrs
Lower Risk
US Multisociety Taskforce & ACS, 2005
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Colonoscopy Miss Rateof Adenomas
AdvancedAdenomas Adenomas
Rex* 24% 6%
Hixson** 15% 0%
*GE 1997**JNCI 1990
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Colonoscopy Miss Ratesfor CRC
Bressler GI 2004 4%Rex GE 1997 5%
3% for Gastroenterologists13% for non-Gastroenterologists
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Reasons for Interval Neoplasia
Inadequate Bowel Prep
Fast Withdrawal Time
Piecemeal Removal of Large Sessile Polyps
Fast Track Cancers — MMR Pathway (15–20%)
US Multisociety TaskForce Rex et al Am J. GE 2002.Barclay et al GIE 2005.
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FOBT in Post-Polypectomy Patients Under Colonoscopy
Surveillance
No. Patients 1,305No. with + FOBT 132No. with Adv. Adn. 17 (23%)No. with Unnecessary 115 (77%)
Colonscopy
Zauber, Winawer et al, GE 2002
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Additional Recommendations
Clear recommendation by endoscopist to PCP
No interval FOBT
Discontinue surveillance with comorbidities
Diagnostic Colonoscopy for interval symptoms
Evolving technology not established for these patients
US Multisociety Taskforce & ACS, 2005
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Proceedings of the Royal Society of Medicine
1977
The Polyp-Cancer Sequence
Basil Morson, M.D. St. Marks Hospital London, UK
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NPS & Erasmus Medical Center Collaboration
NPS Data
MISCAN-MODEL
Evidence for Adenoma Regression
Dynamic Adenoma-Carcinoma Sequence
Implications for Chemoprevention and Nutrition Trials
Loeve, Zauber, Winawer, et al., JNCI 2004.
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National Polyp StudyFlat Adenoma
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FlatAdenomas
Matsui et al.,World J Surg2000.
Aggressive pathology
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National Polyp StudyAdenoma Shape and High Grade Dysplasia
1.3%(6/474)
10.0%(80/802)
7.4%(17/229)
0 2 4 6 8 10 12
Flat
Sessile
Pedcl
P = .0001
10.0% (80/802)
7.4% (17/229)
1.3% (6/474)
Pedunculated
**1/3 of NPS adenomas classified as flat pathologically
O’Brien, Winawer, Zauber et al, Clin GE & Hep, 2004
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National Polyp Study
Relative Risk for Advanced Adenomasat Follow-Up
*Adjusted for adenoma multiplicity and age/family history
• 938 pts — mean 5.9 yrs FU
• 42 pts — developed Advanced Adenomas
• 0.76RR — advanced adenomas in pts with Flat Adenomas relative to No Flat Adenomas*
O’Brien, Winawer, Zauber et al, Clin GE & Hep, 2004
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SummaryImpact of NPS
Randomized Surveillance GuidelinesRisk Stratification GuidelinesPolypectomy Reduces CRC IncidenceScreening ColonoscopyModel for Chemoprevention/Nutrition TrialsModel for Blinded/Unblinded Comparison of colonoscopy and colonography – DCBE/CoDynamic Adenoma Carcinoma Sequence
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Additional NPS Studies
Hyperplastic PolypSerrated AdenomaMortality F/U
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NPS 1980