Transcript Overview of ECOG

ACRIN Annual Meeting
OVERVIEW OF ECOG
Robert L. Comis, M.D.
Chair
Eastern Cooperative Oncology Group
September 22, 2011
eastern cooperative
oncology group
ECOG Constitution Mission Statement
The Eastern Cooperative Oncology Group (ECOG)
is a multidisciplinary organization devoted to the
prevention, treatment and study of neoplastic
disease that will eventually lead to the control and
cure of cancer.
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Organizational Structure
Group
Chair
Vice Chair
Group Chair’s
Office
Administrative
Committees
Academic
Members
Operations
Office
Group
Statistician
Research & Education
Foundation
Principal
Investigators
Statistical
Center
Scientific
Committees
CCOP
Members
Academic
Disease
Members
Committees
Other
Scientific
Committees
Affiliates
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Scientific and Administrative
Senior Leadership
 Chair – Dr. Robert Comis
 Vice Chair – Dr. Peter O’Dwyer
 Group Statistician – Dr. Robert Gray
 Executive Officer – Dr. Bruce Giantonio
 Associate Chair – Dr. Joseph Sparano
 Coordinating Center Co-Directors –
Ms. Jean MacDonald and Ms. Mary Steele
 Director of Operations – Ms. Donna Marinucci
 Regulatory Officer – Dr. Robert Catalano
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Main Academic Member Institutions
U10 Funded
Non-U10 Main Members
 Albert Einstein Cancer Center
 Beth Israel Deaconess
 Emory University School of Medicine
Medical Center
Neoplasicas (Lima, Peru)
 Cancer Institute of New Jersey
 Case Western-MetroHealth
Medical Center

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 Instituto de Enfermedades
 Ireland Cooperative Oncology
Research Group
 New York University Medical Center
Fox Chase Cancer Center
Indiana University Medical Center
Johns Hopkins University
Mayo Clinic
 Stanford University
 The Penn State Cancer Institute
 Tufts Medical Center
Northwestern University
 University of Alabama
University of Pennsylvania
 University of Miami
University of Pittsburgh
University of Wisconsin
Vanderbilt University
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Primary CCOPs



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
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


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
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Colorado Cancer Research Program CCOP
Cook County MBCCOP*
Evanston Hospital CCOP
Kalamazoo CCOP
Main Line Health CCOP
Marshfield Clinic CCOP
Medical College of Georgia MBCCOP*
Meharry Medical College MBCCOP*
Metro-Minnesota CCOP
Ochsner CCOP
Oklahoma CCOP
*Minority Based CCOP
San Juan MBCCOP*
SUNY Downstate MBCCOP*
St Vincent Hospital Regional Center CCOP
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Administrative and Scientific
Organizational Structure
Administrative Committees
- Audit
- CRA
- Data Monitoring
- Executive Review
- Nominating
- Oncology Nursing
- Patient Representative
- Pharmacy
- Radiation Oncology
- Surgery
Scientific Committees
Disease Committees
Other Scientific Committees
- Breast
- Laboratory Science
- Gastrointestinal
and Pathology
- Genitourinary
- Developmental Therapeutics
- Head and Neck
- Pathology Coordinating
- Leukemia
Office/Reference Laboratory
- Lymphoma
- Central Immunologic
- Melanoma
Monitoring Laboratory
- Myeloma
- Leukemia Laboratory
- Thoracic
- Cytogenetics
DCP Funded Committees:
- Patient Outcomes, Survivorship and Underserved
- Prevention
- Symptom Management
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Accrual
Registrations to Therapeutic Studies
9073
6975
8574
5737
5220
4465
5042
3450
3157
93
-9
7
19
98
19
99
20
00
20
01
20
02
20
03
20
04
20
05
20
06
20
07
20
08
20
09
Registrations
10000
9000
8000
7000
6000
5000
4000
3000
2000
1000
0
(Average)
(Projected)
Grant Year
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CTSU Participation 2004-2009
ECOG Participation in CTSU Menu Studies
ECOG studies on the CTSU menu
31
CTSU studies “endorsed” by ECOG
44
CTSU patients accrued to ECOG studies
11,417
ECOG patients accrued to CTSU studies
6,618
ECOG patients accrued to other intergroup studies
1,714
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Major Accomplishments
 Six studies led to new standard of care and FDA indications
 Bevacizumab in metastatic colon (E3200), lung (E4599),
breast (E2100)
 Rituximab in indolent (E1496) and aggressive
lymphoma (E4494)
 Thalidomide in multiple myeloma (E1A00)
 Two phase III adjuvant trials:
 E5103 – bevacizumab + chemotherapy in HER2negative breast cancer
 E1505 – bevacizumab + chemotherapy in stage IB – IIIA
NSCLC
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Major Accomplishments
 Head and Neck cancer: defined prognostic and
predictive roles of p53 mutations and HPV+
 AML: established superiority of high dose
daunorubicin induction
 Adult ALL: defined new adverse cytogenetic
parameters
 Breast cancer: described VEGF SNPs related to
response and toxicity; and potential new
therapeutic targets (eg, GRB-7)
 Multiple Myeloma: established superiority of low
dose dexamethasone plus lenalidomide in
induction therapy
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Publication Record (2004-2008)
JCO
93
Blood
18
NEJM
9
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Peer-Review Funding: 2004-2008
 Laboratory Science and Pathology
Committee (LSPC)
 Reviews, comments on and approves
all ECOG related grant studies prior
to submission
 22 R01 and R21 proposals were reviewed and
approved by LSPC
 50% of RO1 and R21 submissions were funded
by NIH
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Peer-Review Funding: 2004-2008
NIH
Total
29
R01
*8/14 correlative research grants
R21/Other
21*/29 (72%)
8/29 (28%)
Other
Breast Cancer Research Foundation
2
Susan B. Komen Foundation
1
American Cancer Society
1
Lymphoma Research Foundation
1
Leukemia and Lymphoma Society
2
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Major Accomplishments
 Key components of our Translational
Science effort
 Laboratory Science and Pathology Committee
 PCO-RL and other core laboratories
 Developmental Therapeutics Committee
 Pharmacogenetics subcommittee studies
 Leukemia Laboratory Committee and Leukemia
Translational Research Laboratory
 Translational Science Team
 IT infrastructure
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Major Accomplishments
 Established scientific infrastructure to perform
large-scale biomarker driven studies
 Launched two large marker-driven phase III
studies
 E5202 – stage II colon cancer (MSI; 18q LOH)
 TAILORx (PACCT-1) – node negative breast
cancer (Oncotype-DX)
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E5202 Trial Schema
High-Risk Patients
MSS/18q LOH or
MSI-L/18q LOH
are
RANDOMIZED
Stratify:
Disease stage
(IIA or IIB)
Microsatellite stability
(stable vs MSI)
18q LOH
Low-Risk Patients
MSS or MSI-L with
retention of 18q alleles
MSI-H
Arm A:
mFOLFOX6
q2w × 12
Arm B:
mFOLFOX6 +
bevacizumab*
q2w × 12
Arm C:
Observation only
MSI-L = low-level microsatellite instability
MSI-H = high-level microsatellite instability
*bevacizumab continued for an additional 6 months
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Integral Biomarker Specimen Flow—E5202
Fax results - avg 4 working days
5 working days
Surgery
6
0
d
a
y
s
m
a
x
Site registers
patient, ships
2 blocks
(1 tumor,
1 normal)
PCO-RL *
Laboratory
QC and
Processing
ECOG
Rando
Site registers
patient to
Treatment
MDACC* tests
for 18qLOH,
MSI
Fax results - avg 4 working days
* CAP-accredited lab for CLIA-88 compliance
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General Themes for the Future
 Study “targeted” therapies with the ultimate goal
of developing new potentially curative strategies
 Define new predictive and prognostic factors
which lead to hypothesis driven clinical trials
 Continue to develop both laboratory-based
and IT infrastructure
 Build upon new data from existing pivotal studies
undergoing completion and analysis
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