Transcript Slide 1

Overview of NCCTG
Group Organization
and
Research
Jan C. Buckner, MD
Group Chair
November 12, 2010
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NCCTG Organizational Overview
MCCC and other
academic centers
Community
Oncologists
Idea
Generators
NCCTG
Leadership
NCCTG
Programs
Community
Oncology
Programs
NCI
Cooperative
groups
Industry
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Community-Based Partnership
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NCCTG in 1977
AK
Saskatchewan
Ontario
WA
MT
ME
ND
MN
OR
ID
WY
SD
NV
KS
CA
AZ
NM
OK
MO
KY
MS
TX
PA
WV
NJ
DC
NC
SC
AL
GA
LA
FL
Mexico
PR
HI
RI
CT
DE
MD
VA
TN
AR
MA
NY
IN OH
IL
UT
CO
MI
WI
IA
NE
VT NH
The 43 NCCTG Memberships Are
Headquartered in 30 States & Canada
AK
Saskatchewan
WA
MT
ME
ND
VT NH
MN
OR
ID
WY
NV
SD
CO
PA
IA
KS
IL
MO
IN
OK
AZ
WV
NM
MS
TX
RI
CT
DE
MD
VA
DC
NC
TN
AR
NJ
OH
KY
CA
MA
NY
WI
NE
UT
MI
SC
AL
GA
LA
FL
HI
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NCCTG has 392 treating locations
in 35 states as well as Canada
AK
Saskatchewan
2
8
WA
MT 20
OR 9
ID
WY
UT
1
CA
16
CO
ME 1
ND
MN
6
1
NV
6
11
20
SD
33
VT
MI
WI
32
IA 27
NE
26
IN
IL
MO
KS
12
54
AZ
8
2
AR
MS
NM
1
2
LA
AL
NH
MA
RI
CT 1
NJ
DE
MD
7 PA
47
WV 3 VA
DC
1 NC
TN
OK
TX
OH
KY
6
3
1 NY
3
2
SC
GA
4
FL
4
HI
18
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Community Member Involvement
• Co-Chairs of scientific committees
• Participate in protocol review
• Co-chairs of protocols
• ~80% of accrual
• Audits
• Patient Advocate Network
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NCCTG Organizational Overview
MCCC and other
academic centers
Clinical data
Community
Oncologists
Idea
Generators
NCCTG
Leadership
Community
Oncology
Programs
NCI
Cooperative
groups
Biospecimens
Industry
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Mayo Clinic Cancer Center
• Leadership
• Integrated systems
• Financial support
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Mayo Clinic Cancer Center
• Leadership
• Integrated systems
• Financial support
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Mayo Clinic Cancer Center
• Leadership
• Integrated systems
• Financial support
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Specific Aims
1 Improved therapeutics
• To improve the duration and quality of life
of cancer patients
2 Translational research
• To improve the understanding of cancer biology
and the biological consequences of treatment
3 Trial design and conduct
• To improve clinical trial design and conduct
4 Cancer prevention and control
• To provide an infrastructure for studies of cancer
prevention and symptom management
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NCCTG Strategic Plan - 2010
Goals
1. To advance the practice of oncology by
performing high quality clinically relevant
trials in the community
2. To enhance the science of cancer care
by promoting translational research
3. To expand research portfolio to include
screening, prevention, survivorship and
biomarker trials
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NCCTG Strategic Plan - 2010
Goals
4. To enhance the delivery of cancer care
5. To enhance collaboration with
cooperative groups and other research
organizations with similar mission
6. To improve trial quality and conduct to
achieve maximum value
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NCCTG Committees
Disease Specific
Breast
Gastrointestinal
Lung
Neuro-oncology
Discipline-Oriented Scientific
• Cancer Control
• Novel Therapeutics
• Quality of Life
Modality
• Pathology
• Radiation Oncology
• Surgery
Core Function
• Audit
LIAISONS
• Cancer Health Disparity
• Oncology Nursing
• Clinical Research Assoc Board
• Patient Advocates
Statistics and Data Center
• Biostatistics
Advisory
• Translational Research Coord
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Aim 1 Improved Therapeutics
To improve the duration and
quality of life of cancer patients
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Aim 1 Improved Therapeutics
Accomplishment
NSABP B-31/N9831 Joint Analysis:
Impact of Adding Trastuzumab to AC  Paclitaxel
on Disease-Free Survival*
100
87.1%
85.3%
(133 events)
80
75.4%
% surviving
disease-free
Trastuzumab
67.1%
60
Control
(261 events)
40
Median FU 2.0 yr
20
P<0.0001
HR=0.48
0
0
1
2
3
4
5
Years after randomization
*N9831 arm B (sequential trastuzumab after ACP) not included in joint analysis
Romond et al. N Engl J Med 2005;353:1673
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Aim 1 Improved Therapeutics
Accomplishment
N9741: Establishing FOLFOX
as standard 1st line therapy
% alive
Oxaliplatin +
5-FU/LV
(FOLFOX)
100
80
R
Irinotecan +
oxaliplatin
(IROX)
60
40
N=795
Irinotecan +
5-FU/LV
(IFL)
IFL
FOLFOX
IROX
20
Median
14.8 mo
19.5 mo
17.4 mo
P=0.0001
P=0.04
P=0.09
0
0
Goldberg RM et al: J Clin Oncol 2004
1
Years
2
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Aim 1 Improved Therapeutics
Accomplishment
NCCTG 93-43-53 (INT0146)
Phase III Laparoscopic Colon Trial
Overall Survival (%)
100
1.0
80
0.8
60
0.6
40
0.4
20
0.2
P=0.51
0
0
1
2
3
Years
4
Cumulative Incidence
of Recurrence
Colectomy
Open
Laparoscopically-assisted
P=0.32
0.0
5
0
1
2
3
4
5
Years
Nelson, NEJM, 2004; 350:2050
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Aim 1 Improved Therapeutics
Accomplishment
86-72-51: RT in LGG
Overall Survival (%)
100
80
60
50.4 Gy
40
64.8 Gy
20
P=0.48
0
0
1
2
3
4
5
6
7
8
9
10
Years from randomization
Shaw et al: JCO 2002; 20:2267-76
Brown et al: JCO 2003; 21:2519-24
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Aim 1 Improved Therapeutics
Future Plans
Measure
of Success
THE
PATIENT
Survival
AND
Quality of Life
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Aim 2 Translational Research
To improve the understanding
of cancer biology and the biological
consequences of treatment
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Aim 2 Translational Research
Accomplishment
CYP2D6 and Tamoxifen
Relapse-free Survival
100
80
CYP2D6 WT/WT
60
%
40
CYP2D6 *4/WT
20
CYP2D6 *4/*4
P=0.020
0
0
2
4
6
8
10
12
Years after randomization
Goetz et al J Clin Oncol. 2005;23(36):9312-8
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Aim 2 Translational Research
Accomplishment
t(1p;19q) and Survival in LGG
Overall Survival (%)
100
80
Median
survival (yr)
60
40
20
P=0.003
Fusion
11.9
No fusion
8.1
0
0
2
4
6
8
10
12
14
16
18
Years of follow-up
Jenkins et al (in press)
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Aim 2 Translational Research
Future Plans
THE PATIENT
Patient
Biology
Pharmacogenomics
Immunology
Tumor
Biology
Tumor
tissue
biomarkers
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Aim 3 Trial Methodology
To improve methods
for performing clinical trials
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Accomplishment
Aim 3 Trial Methodology
3-year DFS vs 5-year OS
0.80
0.75
0.70
Overall
survival
May 05, 2004:
ODAC recommends
3-yr DFS as new
regulatory endpoint
for full approval
in adjuvant colon
cancer
0.65
0.60
20,898 patients, 18 trials
5 yr OS= 0.0002+0.998*3 yr DFS
0.55
0.50
0.50
0.55
0.60
0.65
0.70
Disease-free survival
0.75
0.80
Sargent et al, JCO 2005
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Accomplishment
Aim 3 Trial Methodology
Overall Survival
Recurrent GBM Patients
100
Median
survival (mo.)
11.6
Progression-free at 6 mo
3.3
Progressor at 6 mo
80
Survival
(%)
60
40
20
0
0
12
Months
24
36
Ballman et al: Neuro-Oncol (in press)
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Aim 3 Trial Methodology
Accomplishment
10 Point (1/2 Standard Deviation) Decrease
in Fatigue
30
20
Epoetin Alfa
Placebo
%
10
0
Baseline Cycle 1 Cycle 2 Cycle 3 Cycle 4
Sloan, Cella, Hays: JCE 2005, December
Norman, Sloan, Wyrwich: Medical Care 41(5):582-592, 2003
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Questions
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