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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
Diagnosis of Large Bowel Cancerin Asymptomatic Patients
Screening of Asx, PeopleIntermittent BleedingDietary ControlGuaiac Cards
David H. Greegor, MDColumbus, Ohio
JAMA Sept. 18, 1967
Hirschowitz, 1950s
Colonoscopyc. 1970
Adenomatous Polyp
Shinya & Wolf, 1976
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.
Post-Polypectomy Surveillance1970s
Common Practice:Annual Follow-up Colonoscopy
Cori Data. Lieberman
Colonoscopy workloadabout 25% surveillance inpeople over 50 yrs. of age
National Polyp Study
Randomized Trial
Surveillance Intervals
Surveillance Methods
CRC Incidence
Adenoma-Carcinoma Model
7 Clinical Centers
MSK Coord. Center
1980
Colorectal Cancer Incidence in NPS Following Colonoscopic Polypectomy
(1418 pts; 8401 person yrs)
Winawer, Zauber et al. 1993. NEJM 329:1977-81
National Polyp StudyAdvanced Adenomas at Follow-Up
3%
32%
R
3%
1 year 3 year
Winawer, Zauber et al. NEJM 1993.
U.S. Colorectal Cancer Screening Guidelines
Consensus
U.S. Preventive Services Task Force 1996
GI Consortium 1997
American Cancer Society 1997
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
NPSColonoscopy/Barium Enema
ComparisonBlinded/Unblinded Method
Comparison of DCBE & Colonoscopy*
862 Paired Exams in 580 Pts.
DCBE Detection 48% for Adenomas >1 cm
*Winawer, Zauber et al, NEJM 2000
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
1380-4*Zauber, Winawer et al, GE 1997
Post-Polypectomy SurveillancePo
lype
ctom
y IncreasedRisk
LowerRisk
30%
70%3 yr
5 yr
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
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
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
Colonoscopy Miss Rateof Adenomas
AdvancedAdenomas Adenomas
Rex* 24% 6%
Hixson** 15% 0%
*GE 1997**JNCI 1990
Colonoscopy Miss Ratesfor CRC
Bressler GI 2004 4%Rex GE 1997 5%
3% for Gastroenterologists13% for non-Gastroenterologists
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.
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
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
Proceedings of the Royal Society of Medicine
1977
The Polyp-Cancer Sequence
Basil Morson, M.D. St. Marks Hospital London, UK
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.
National Polyp StudyFlat Adenoma
FlatAdenomas
Matsui et al.,World J Surg2000.
Aggressive pathology
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
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
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
Additional NPS Studies
Hyperplastic PolypSerrated AdenomaMortality F/U
NPS 1980