Transcript Slide 1
Overview of NCCTG
Group Organization and Research
Jan C. Buckner, MD Group Chair November 12, 2010 CP1223393-1
NCCTG Organizational Overview
MCCC and other academic centers Community Oncologists Idea Generators NCI Cooperative groups Industry NCCTG Leadership NCCTG Programs Community Oncology Programs
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Community-Based Partnership
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AK NCCTG in 1977 CA OR WA ID NV AZ UT MT Saskatchewan WY NM CO Ontario ND SD MN WI MI NE KS OK IA MO IL AR IN OH MS KY TN AL TX LA WV ME VT NH NY PA VA MA RI CT NJ DE MD DC NC SC GA FL Mexico PR HI
AK The 43 NCCTG Memberships Are Headquartered in 30 States & Canada CA OR NV WA AZ ID UT Saskatchewan MT WY CO NM ND SD NE KS MN WI IA MO IL OK AR MI IN OH MS KY TN AL TX LA WV ME VT NH NY PA MA RI CT NJ DE MD VA DC NC SC GA FL HI
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1 AK NCCTG has 392 treating locations in 35 states as well as Canada WA OR 9 8 ID 1 CA NV 3 AZ UT Saskatchewan 2 MT WY 16 8 NM 20 1 CO 11 6 6 20 ND SD NE KS TX OK 1 MN 33 2 IA WI 27 MO AR 32 6 IL 54 MS MI 26 IN 12 OH KY 47 7 WV 1 PA 3 ME 1 VT NH NY VA MA RI CT NJ DE MD DC 1 NC 1 TN 3 SC AL 2 GA 2 LA 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 CP1223393-7
NCCTG Organizational Overview
MCCC and other academic centers Community Oncologists Idea Generators NCI Cooperative groups Industry NCCTG Leadership Clinical data Community Oncology Programs Biospecimens
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Mayo Clinic Cancer Center
•
Leadership
•
Integrated systems
•
Financial support
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Mayo Clinic Cancer Center
•
Leadership
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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
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 CP1223393-12
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 CP1223393-13
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 CP1223393-14
NCCTG Committees Discipline-Oriented Scientific
• Cancer Control • Novel Therapeutics • Quality of Life
Modality
• Pathology • Radiation Oncology • Surgery
Core Function
• Audit • Cancer Health Disparity • Oncology Nursing • Clinical Research Assoc Board • Patient Advocates
Statistics and Data Center
• Biostatistics
Advisory
• Translational Research Coord Breast
Disease Specific
Gastrointestinal Lung Neuro-oncology
LIAISONS
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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% 80 Trastuzumab (133 events) 75.4% % surviving disease-free 60 67.1% Control (261 events) 40 20 Median FU 2.0 yr P<0.0001
HR=0.48
0 0 1 2 3 Years after randomization 4 5 *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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R Aim 1 Improved Therapeutics
Accomplishment
N9741: Establishing FOLFOX as standard 1st line therapy Oxaliplatin + % alive 100 5-FU/LV (FOLFOX) 80 N=795 Irinotecan + oxaliplatin (IROX) Irinotecan + 5-FU/LV (IFL) 60 40 20 0 0 IFL FOLFOX IROX Median 14.8 mo 19.5 mo 17.4 mo P=0.0001
P=0.09
P=0.04
1 Years 2 Goldberg RM et al: J Clin Oncol 2004
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100 80 60 40 20 0 0 Aim 1 Improved Therapeutics
Accomplishment
NCCTG 93-43-53 (INT0146) Phase III Laparoscopic Colon Trial 1 Overall Survival (%) 2 Years 3 1.0
0.8
0.6
0.4
0.2
P=0.51
4 5 0.0
0 Cumulative Incidence of Recurrence Colectomy
Open Laparoscopically-assisted
1 2 Years 3
P=0.32
4 5 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 40 20 0 0 1 50.4 Gy 64.8 Gy
P=0.48
2 3 4 5 6 7 Years from randomization 8 9 10 Shaw et al: JCO 2002; 20:2267-76 Brown et al: JCO 2003; 21:2519-24
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Aim 1 Improved Therapeutics THE PATIENT
Future Plans
Measure of Success 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 0 0 CYP2D6 *4/*4
P=0.020
2 4 6 8 Years after randomization 10 12 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 60 40 Fusion
Median survival (yr) 11.9
20 0 0
P=0.003
2 No fusion 4 6 8 10 12 Years of follow-up 14
8.1
16 18 Jenkins et al (in press)
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Aim 2 Translational Research THE PATIENT
Patient Biology Pharmaco genomics Immunology Tumor Biology Tumor tissue biomarkers
Future Plans
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Aim 3 Trial Methodology To improve methods for performing clinical trials
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Aim 3 Trial Methodology
Accomplishment
3-year DFS vs 5-year OS 0.80
0.75
0.70
May 05, 2004: ODAC recommends 3-yr DFS as new regulatory endpoint for full approval in adjuvant colon cancer Overall survival 0.65
0.60
0.55
20,898 patients, 18 trials 5 yr OS= 0.0002+0.998*3 yr DFS 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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Aim 3 Trial Methodology
Accomplishment
Overall Survival Recurrent GBM Patients
100 80 Progression-free at 6 mo Progressor at 6 mo Median survival (mo.) 11.6
3.3
Survival (%)
60 40 20 0 0 12 24 36
Months 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 10
Epoetin Alfa Placebo
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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