Overview of NCCTG Group Organization and Research Jan

Overview of NCCTG Group Organization and Research Jan

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 NCCTG Leadership NCCTG Programs Community Oncology Programs NCI Cooperative groups Industry CP1223393-2

Community-Based Partnership CP1223393-3 NCCTG in 1977 AK Saskatchewan WA OR MT ID NV ME ND WY MN SD CO CA NM OK TX

MO PA KY WV MS AL NJ DC NC SC GA LA FL Mexico PR HI RI CT DE MD VA

TN AR MA NY IN OH IL KS VT NH MI WI IA NE UT AZ Ontario The 43 NCCTG Memberships Are Headquartered in 30 States & Canada AK

Saskatchewan WA MT OR NV ID UT WY ND CA IA KS NM TX IL MO VT NH MI WI

OK AZ MN SD NE CO ME IN NY PA WV AL RI CT DE MD VA NC TN MS NJ

OH KY AR MA DC SC GA LA FL HI CP1223393-5 1 NCCTG has 392 treating locations in 35 states as well as Canada AK Saskatchewan MT 20 OR 9 ID NV

1 CA 2 8 WA UT 6 6 WY 1 16 CO 11 20 ND SD ME 1 MN 33 AZ

32 IN 12 54 2 AR MS NM HI 1 LA 2 4 AL RI CT 1 NJ DE MD 7 PA 47

WV 3 VA DC 1 NC TN OK TX OH KY 6 MA 1 NY 26 IL MO KS 3 8 MI

WI IA 27 NE VT NH 3 2 SC GA FL 4 18 CP1223393-6 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 Clinical data

Community Oncologists Idea Generators NCCTG Leadership Community Oncology Programs NCI Cooperative groups Biospecimens Industry CP1223393-8 Mayo Clinic Cancer Center Leadership Integrated systems Financial support CP1223393-9 Mayo Clinic Cancer Center Leadership Integrated systems

Financial support CP1223393-10 Mayo Clinic Cancer Center Leadership Integrated systems Financial support CP1223393-11 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 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 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 CP1223393-15

Aim 1 Improved Therapeutics To improve the duration and quality of life of cancer patients CP1223393-16 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 60 67.1%

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 CP1223393-17 Aim 1 Improved Therapeutics Accomplishment

N9741: Establishing FOLFOX as standard 1st line therapy Oxaliplatin + 5-FU/LV (FOLFOX) R Irinotecan + oxaliplatin (IROX) % alive 100 80 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 CP1223396-18 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 CP1223393-19 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 CP1223393-20 Aim 1 Improved Therapeutics Ch the emo rap y d e

t e es g r Ta rapi the Measure of Success Survival THE PATIENT Ra dia tio n Future Plans AND ry e rg u S Quality of Life CP1223393-21 Aim 2 Translational Research To improve the understanding of cancer biology and the biological

consequences of treatment CP1223393-22 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 CP1223393-23 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) CP1223393-24 Aim 2 Translational Research Future Plans THE PATIENT Patient

Biology Pharmacogenomics Immunology Tumor Biology Tumor tissue biomarkers CP1223393-25 Aim 3 Trial Methodology To improve methods for performing clinical trials CP1223393-26 Aim 3 Trial Methodology Accomplishment 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 CP1223393-27 Aim 3 Trial Methodology

Accomplishment Overall Survival Recurrent GBM Patients 100 Median survival (mo.) Progression-free at 6 mo 11.6 Progressor at 6 mo 3.3 80 Survival (%) 60 40 20 0 0 12 Months 24 36 Ballman et al: Neuro-Oncol (in press) CP1223393-28 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 CP1223393-29 Questions CP1223393-30

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