CP1223393-1

Overview of NCCTGGroup Organization

andResearch

Jan C. Buckner, MDGroup Chair

November 12, 2010

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IdeaGenerators

NCCTGPrograms

NCCTGLeadership

NCCTG Organizational Overview

MCCC and other academic centers

Cooperativegroups

Industry

NCI

CommunityOncologists

CommunityOncologyPrograms

CommunityOncologyPrograms

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Community-Based Partnership

NCCTG in 1977

WA

ORID

MT

Saskatchewan

WY

UTNV

CA

AZ NM

CO

NE

SD

NDMN

MOKS

FL

NC

MI

KY

OH

VA

PA

NY

ME

NHVT

IAIL

WI

Ontario

Mexico

GA

TX LA

ARAL

TN

MS

OK SC

IN

WV

AK

MDDE

NJCT

RI

MA

PR

HI

DC

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WAWA

ORORIDID

MTMT

SaskatchewanSaskatchewan

WYWY

UTUTNVNV

CACA

AZAZ

NMNM

COCO

NENE

SDSD

NDNDMNMN

MOMOKSKS

FLFL

NCNC

MIMI

KYKY

OHOH

WVWV VAVA

PAPA

NYNY

MDMDDEDE

NJNJCTCT

RIRI

MAMA

MEME

NHNHVTVT

IAIA

ILIL

WIWI

DCDC

GAGA

TXTX LALA

ARARALAL

TNTN

MSMS

OKOK SCSC

ININ

The 43 NCCTG Memberships Are Headquartered in 30 States & Canada

HIHI

AKAK

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NCCTG has 392 treating locations in 35 states as well as CanadaAKAK

1

WAWA

ORORIDID

MTMT

SaskatchewanSaskatchewan

WYWY

UTUTNVNV

CACA

AZAZ

NMNM

COCO

NENE

SDSD

NDNDMNMN

MOMOKSKS

FLFL

NCNC

MIMI

KYKY

OHOH

VAVA

PAPA

NYNY

MDMDDEDE

NJNJCTCT

RIRI

MAMA

MEME

NHNHVTVT

IAIA

20

11

6

6

3

ILIL

WIWI

DCDC

33

27

26

54

2

477

4

GAGA2

TXTX LALA

ARARALAL

TNTN

MSMS

OKOK

2

4

2 SCSC3

ININ

1

32

1216 WVWV

1

20

16

1

3

8

9

8

1

1

1

HIHI18

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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

NCCTGLeadership

IdeaGenerators

Clinical data

Biospecimens

MCCC and other academic centers

Cooperativegroups

Industry

NCI

CommunityOncologists

CommunityOncologyPrograms

CommunityOncologyPrograms

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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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3 Trial design and conduct• To improve clinical trial design and conduct

1 Improved therapeutics• To improve the duration and quality of life

of cancer patients

Specific Aims

22 Translational research• To improve the understanding of cancer biology

and the biological consequences of treatment

4 Cancer prevention and control• To provide an infrastructure for studies of cancer

prevention and symptom management

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NCCTG Strategic Plan - 2010Goals

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 - 2010Goals

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

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 Gastrointestinal Lung Neuro-oncology

Disease Specific

LIAISONS

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Aim 1 Improved Therapeutics

To improve the duration andquality of life of cancer patients

NSABP B-31/N9831 Joint Analysis:Impact of Adding Trastuzumab to AC Paclitaxel

on Disease-Free Survival*

Aim 1 Improved Therapeutics Accomplishment

*N9831 arm B (sequential trastuzumab after ACP) not included in joint analysis Romond et al. N Engl J Med 2005;353:1673

0

20

40

60

80

100

0 1 2 3 4 5

Trastuzumab(133 events)

Control(261 events)

% survivingdisease-free

Years after randomization

P<0.0001HR=0.48

Median FU 2.0 yr

87.1% 85.3%

67.1%75.4%

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N9741: Establishing FOLFOXas standard 1st line therapy

N=795

Irinotecan + Irinotecan + oxaliplatinoxaliplatin

(IROX)(IROX)

Irinotecan + Irinotecan + 5-FU/LV5-FU/LV

(IFL)(IFL)

Oxaliplatin + Oxaliplatin + 5-FU/LV 5-FU/LV(FOLFOX)(FOLFOX)

R

Goldberg RM et al: J Clin Oncol 2004

0

20

40

60

80

100

0 1 2Years

% alive

Median

IFL 14.8 mo

FOLFOX 19.5 mo

IROX 17.4 mo

P=0.0001

P=0.09P=0.04

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Aim 1 Improved Therapeutics Accomplishment

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Nelson, NEJM, 2004; 350:2050

NCCTG 93-43-53 (INT0146)Phase III Laparoscopic Colon Trial

0.0

0.2

0.4

0.6

0.8

1.0

0 1 2 3 4 5

Cumulative Incidenceof Recurrence

Years

P=0.320

20

40

60

80

100

0 1 2 3 4 5

Overall Survival (%)

Years

ColectomyOpenLaparoscopically-assisted

P=0.51

Aim 1 Improved Therapeutics Accomplishment

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86-72-51: RT in LGG

Aim 1 Improved Therapeutics Accomplishment

Shaw et al: JCO 2002; 20:2267-76Brown et al: JCO 2003; 21:2519-24

0

20

40

60

80

100

0 1 2 3 4 5 6 7 8 9 10

Overall Survival (%)

Years from randomization

P=0.48

50.4 Gy

64.8 Gy

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Aim 1 Improved Therapeutics Future Plans

THEPATIENT

Targeted

therapiesChemo-

therapy

Radiation Surgery

Measureof Success

Measureof Success

Survival

AND

Quality of Life

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Aim 2 Translational Research

To improve the understandingof cancer biology and the biological

consequences of treatment

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Goetz et al J Clin Oncol. 2005;23(36):9312-8

CYP2D6 and TamoxifenRelapse-free Survival

%

Years after randomization

CYP2D6 WT/WT

CYP2D6 *4/WT

P=0.020

CYP2D6 *4/*4

0

20

40

60

80

100

0 2 4 6 8 10 12

Aim 2 Translational Research Accomplishment

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t(1p;19q) and Survival in LGG

Aim 2 Translational Research Accomplishment

Jenkins et al (in press)

0

20

40

60

80

100

0 2 4 6 8 10 12 14 16 18

Overall Survival (%)

Years of follow-up

P=0.003

Fusion

No fusion

11.9

8.1

Mediansurvival (yr)

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Aim 2 Translational Research Future Plans

THE PATIENT

PatientBiology

Pharmaco-genomics

Immunology

TumorBiology

Tumortissue

biomarkers

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Aim 3 Trial Methodology

To improve methodsfor performing clinical trials

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0.50

0.55

0.60

0.65

0.70

0.75

0.80

0.50 0.55 0.60 0.65 0.70 0.75 0.80

3-year DFS vs 5-year OS

Sargent et al, JCO 2005

Overallsurvival

5 yr OS= 0.0002+0.998*3 yr DFS

May 05, 2004:ODAC recommends

3-yr DFS as new regulatory endpoint

for full approvalin adjuvant colon

cancer

20,898 patients, 18 trials

Disease-free survival

Aim 3 Trial Methodology Accomplishment

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Aim 3 Trial Methodology

0

20

40

60

80

100

0 12 24 36Months

Progression-free at 6 moProgressor at 6 mo

Mediansurvival (mo.)

11.6 3.3

Survival(%)

Overall SurvivalRecurrent GBM Patients

Accomplishment

Ballman et al: Neuro-Oncol (in press)

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Sloan, Cella, Hays: JCE 2005, December Norman, Sloan, Wyrwich: Medical Care 41(5):582-592, 2003

Aim 3 Trial Methodology Accomplishment

10 Point (1/2 Standard Deviation) Decreasein Fatigue

Placebo

Epoetin Alfa

30

20

10

0Baseline Cycle 1 Cycle 2 Cycle 3 Cycle 4

%

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Questions