update on the confirm study - world endo
TRANSCRIPT
Update on the CONFIRM Study Colonoscopy versus Fecal Immunochemical Test
in Reducing Mortality from Colorectal Cancer
Jason A. Dominitz, MD, MHS
CONFIRM Co-Chairs
Jason Dominitz, MD, MHS National GI Program Director
Department of Veterans Affairs VA Puget Sound HCS
Professor of Medicine University of Washington
Seattle, WA
Douglas J. Robertson, MD, MPH GI Section Chief
VA Medical Center White River Junction, Vermont
Professor of Medicine Geisel School of Medicine at
Dartmouth & The Dartmouth Institute
Hanover, New Hampshire
Primary Aim
To determine if a strategy of screening colonoscopy decreases CRC mortality over 10 years in average
risk adults as compared to annual FIT screening
Secondary Aims 1. To determine if a screening colonoscopy decreases 10 year CRC incidence as
compared to annual FIT screening
2. To evaluate the safety of screening colonoscopy
3. To evaluate the association between colonoscopists’ characteristics and the initial detection of colorectal neoplasia, complications and post-colonoscopy CRC
Recruit 50,000‘screen eligible’ Veterans (Age 50-75)
Randomize
Screening
Colonoscopy
Annual FIT
Test
FIT Test
Positive?
10th Year of
Follow-
Up?
Evaluation by Site
PI for further
Follow-up
Follow-up for outcomes over 10+ years
CRC Mortality (Primary Outcome)
CRC Incidence (Secondary Outcome)
Yes
No
No
Yes
Dominitz and Robertson et al. Am J Gastroenterol 2017;112:1736-46
Seattle, WA
White River Jct., VT Portland, OR
San Diego, CA
Loma Linda, CA
Phoenix, AZ
Denver, CO
Ann Arbor, MI
Minneapolis, MN
Houston, TX
Dallas, TX
Boston, MA Providence, RI
Northport, NY
Cleveland, OH
Clarksburg, WV
Durham, NC
Gainesville, FL
Indianapolis, IN
Kansas City, MO
Memphis, TN Los Angeles, CA
Fresno, CA
Salt Lake City, UT
Oklahoma City, OK
St. Louis, MO
Detroit, MI Madison, WI
Chicago, IL
Miami, FL
Tampa, FL
Richmond, VA
Philadelphia, PA Baltimore, MD
Long Beach, CA
Atlanta, GA
West Haven, CT
CSP #577 CONFIRM Study Sites
Orlando, FL
San Juan, PR
Salisbury, NC
Honolulu, HI
Little Rock, AR
East Orange, NJ
Washington, DC
Manchester, NH
Dominitz and Robertson et al. Am J Gastroenterol 2017;112:1736-46
Louisville, KY
Study Participants-Age Distribution N=50,126
0
2000
4000
6000
8000
10000
12000
14000
16000
18000
50-55 55-<60 60-<65 65-<70 70-75
Nu
mb
er o
f Pa
rtic
ipan
ts
Age Group
34%
18%
21% 20%
7%
Mean Age = 59.1 years
Study Participants-Race and Ethnicity N=50,126
White 72%
Black 25%
Native American [PERCENTAGE] Non-
Hispanic/Latino, 88%
Puerto Rican, 4%
Other Hispanic/Latino, [PERCENTAGE]
Mexican, 3%
Cuban, 1%
Study Flow Chart and Colonoscopy Findings
Adenoma Detection Rate = 45.7% Advanced Adenoma Detection = 9.4% Sessile Serrated Lesion Detection = 3.7%
Predictors of Advanced Adenomas and Sessile Serrated Polyps
• Please come to our poster on Monday!
Name of presenter
Adverse Events (N=523)
Type Count
Blood per rectum 182
Abdominal pain 62
Proctalgia 11
Mild 491 84%
Moderate 88
15%
Severe 6
1% Most Common Adverse Events by Type
N=528 total events
Adverse Events (N=523)
Mild 491 84%
Moderate 88
15%
Severe 6
1%
N=528 total events
Type Count
Prep related severe nausea and vomiting
2 cancelled procedure 1 never completed procedure
3
Abdominal pain requiring ER visit 2
Severe cramping, bleeding and chest pain post-procedure
1
Severe AE (n=6)
Serious Adverse Events
Experienced SAE
N=235 (1.3%)
Not Related
N=148 Possibly Related
N=38 Definitely Related
N=52
SAE Type Count
Serious Bleeding 31 (0.18 %)
Cardiovascular Events 31 (0.18%)
“Perforations” 5 (0.03%)
Study
Colonoscopy
N=17,485
“Perforations” (n=5) Age/
Gender Race Endoscopist
(Fellow) Polypectomy Attribution Surgery Description
A 65/M White GI (No) No Yes Left colectomy
Sigmoid perf at time of study colonoscopy & to immediate surgery
B 68/M White Missing (No) No Yes Open Sigmoid
resection
Sigmoid perforation at time of study colonoscopy & to immediate surgery
C 51/M White GI (No) No Possibly Lap Sigmoid
Resection
Diverticulitis 7 days after procedure complicated by abscess requiring IR
drainage and surgery
D 55/M AA GI (Yes) Yes Yes No Immediately hypotensive and diaphoretic after large polyp removal.
No evidence of pneumoperitoneum on CT, but mild fluid collection ascending
colon.
E 67/M White GI (Yes) Yes Yes No Severe post-procedure pain developing 24-48 hours after colonoscopy; FA on
KUB; pneumatosis on CT
CONFIRM Biorepository
• Blood for DNA and RNA
• Storage of FIT kits
• Access to pathology specimens
• 10,703 enrolled in the biorepository
Name of presenter
Summary 1) CONFIRM randomized 50,126 average risk adults to screening colonoscopy vs.
FIT and is following for 10+ years for cancer outcomes
2) Adenomas were found in 45.7% of Veterans undergoing screening colonoscopy
(far exceeding the benchmark adenoma detection rate)
3) Our study confirms the importance of several demographic and environmental
risk factors for adenomas, AA and sessile serrated lesions
4) AE and SAE related to colonoscopy occur in approximately 3.0% and 0.5% of
colonoscopies, respectively
5) Polypectomy is an independent predictor of SAE’e
6) We anticipate many more analyses from this prospective cohort and
biorepository
CONFIRM Study Team Study Co-Chairs
Jason A. Dominitz, MD, MHS, Seattle. WA Douglas J. Robertson, MD, MPH, White River Junction, VT
National Chairs’ Offices
Meaghan Larson, MPH, National Coordinator, Seattle, WA Andrew LaCasse, National Coordinator, White River Junction, VT
West Haven CSP Coordinating Center
Tassos Kyriakides, PhD Director Alex Beed, MS, Study Biostatistician
Lynn Tommessilli, Study Project Manager
Albuquerque Pharmacy Coordinating Center
Kathy Boardman, RPh, Study Pharmacist
Barbara Del Curto, Project Manager
Other Executive Committee Members
Dennis Ahnen, MD, Denver, CO
Tom Imperiale, MD, Indianapolis, IN
David Lieberman, MD, Portland, OR
Dawn Provenzale, MD, MS, Durham, NC
Shahnaz Sultan, MD, Minneapolis, MN
Aasma Shaukat, MD, Minneapolis, MN
Local Site Investigators - Present • Aasma Shaukat, MD, MPH
• Adnan Said, MD, MS
• Amelia (Beth) Underwood, MD
• Andrew J. Gawron, MD
• Andrew M. Kaz, MD
• Charles H. Beymer, MD, MPH
• Charles Kahi, MD
• Christian S. Jackson, MD
• Christopher Lenza, DO
• Claudio Tombazzi, MD
• Curt H. Hagedorn, MD
• David Lieberman, MD
• Deborah A. Fisher, MD, MHS
• Deepak Desai, MD
• Devang Prajapati, MD
• Deborah A. Fisher, MD, MHS
• Deepak Desai, MD
• Devang Prajapati, MD
• Dipendra Parajuli, MD
• Doris H. Toro, MD
• Douglas J. Nguyen, MD
• E. Carter Paulson, MD
• Edward Sun, MD
• Endashaw Omer, MD, MPH
• Eric K. Taylor, NP
• Erik C. von Rosenvinge, MD
• Fadi Antaki, MD
• Folasade P. May, MD, MPhil, PhD
• Frank S. Pancotto, MD
• Gyorgy Baffy, MD, PhD
• Heather Hockman, MD
• Heiko Pohl, MD
• Helen W. Wong, MD
• Ildiko Halasz, MD
• Jed E. Olson, MD
• Jeffrey A. Gill, MD
Local Site Investigators - Present • Jill E. Elwing, MD
• Joseph Manlolo, MD
• Joseph R. Pisegna, MD
• Katarina B. Greer, MD, MS
• Kerry Dunbar, MD
• Kittichai Promrat, MD
• Lyn Sue Kahng, MD
• Margaret F. Kinnard, MD
• Michael Yao, MD
• Michele Young, MD
• Mitchell Schubert, MD
• Mohammad Madhoun, MD
• Nancy C. Ho, MD
• Paul A. Feldman, MD, MSC
• Petr Protiva, MD
• Prateek Sharma, MD
• Priscilla Magno, MD
• Rebecca J. Beyth, MD, MSc
• Rhonda A. Cole, MD
• Riaz Cassim, MD
• Robert H. Lee, MD, MAS
• Ronald Fernando, MD
• Sameer Saini, MD, MS
• Samir Gupta, MD, MSCS
• Samuel B. Ho, MD
• Stacy Menees, MD
• Stephan Goebel, MD
• Swati G. Patel, MD
• Tarun Rai, MD
• Thomas F. Imperiale, MD
• William M. Tierney, MD
• William V. Harford, Jr. MD
Local Site Investigators - Past •Christopher Lopez, MD
•Dennis J. Ahnen, MD
•Farrukh H. Merchant, MD
•Fernando V. Ona, MD
• Isabelita Cordoba Rellosa, MD
• J. Andy Mengshol, MD, PhD
• Juan Diego Baltodano, MD
•Kenneth H. Berman, MD
•Lubna Maruf, MD
•M. Mazen Jamal, MD, MPH
•Mae F. Go, MD
•Marcos C. Pedrosa, MD, MPH
•Martin Tobi, MB, ChB
•Mohammad Wehbi, MD
•Phillip Schoenfeld, MD, MSEd, MSc
•Ranjan C.V. Mascarenhas, MD
•Robert D. Shaw, MD
•Shahnaz Sultan, MD, MHSc
•Steven R. Warlick, MD
•Susan Goldsmith, MD
•Toan D. Nguyen, MD