American College of Surgeons Oncology Group

1
American College of Surgeons Oncology Group
Heidi Nelson, M.D. David M. Ota, M.D.
2
Who are we?
3
ACOSOG
Operations and Membership Center
Members
Scientific Leadership
Statistics and Data Center
4
Specialty
Hospital type
6
2
15
18
4
46
37
37
35
5
Members ACOSOG Networks
British Columbia, Canada Ontario, Canada
Key
Breast IDIGs GI IDIGs Thoracic IDIGs
6
Scientific Leadership Group Stability
Executive Committee Chair
A. Marilyn Leitch, M.D.
Group Co-Chairs
Heidi Nelson, M.D.
David M. Ota, M.D.
Scientific Committees Chairs
Kelly K. Hunt, M.D. Breast
Peter W.T. Pisters M.D. GI
Mitchell C. Posner, M.D. GI
Joe B. Putnam, Jr., M.D. Thoracic
Elaine Mardis, Ph.D. BTSC
Modality (Administrative) Committees Chairs
Bettye L. Greene, R.N. Patient Advocate
Mark Watson, M.D. CSBPC
Chaitanya Divgi, M.D. Diagnostic Imaging
Matthew Ellis, M.D. Medical Oncology
Charles Thomas, Jr., M.D. Radiation Oncology
Jennifer B. Zoole, RN Nursing/CRA
Peer Review Committees Chairs
Lee Wilke, M.D. CSRC
Dennis Wigle, M.D., Ph.D. TSRC
Operations and Membership Center
Elizabeth D. Martinez, BS Group Administrator
Statistics and Data Center
Karla V. Ballman, Ph.D. Group Statistician
Administrative Committees Chairs
Lisa K. Jacobs, M.D. Audit
Gerard M. Doherty, M.D. Constitution and Bylaws
Henry M. Kuerer, M.D., Ph.D. Education
Peter Angelos, M.D., Ph.D. Ethics
A. Marilyn Leitch, M.D. Membership
Lisa A. Newman, M.D. Special Populations
Robin McLeod, M.D. DMC
Executive Committee Members-at-Large
Ross Abrams, M.D.
Steven Brower, M.D.
Jeffrey Drebin, M.D.
Bryan Meyers, M.D.
Raphael Pollock, M.D.
Merrick Ross, M.D.
7
American College of Surgeons

• The American College of Surgeons is a scientific
  and educational association of surgeons that was
  founded in 1913 to improve the quality of care
  for the surgical patient by setting high
  standards for surgical education and practice.

8
American College of Surgeons

• 73,000 U.S. members
• Several cancer programs or initiatives
• Commission on Cancer
• National Cancer Database
• AJCC Staging
• ACOSOG

9
American College of SurgeonsCommission on Cancer

• Established by the American College of Surgeons
  in 1922
• Consortium of 50 professional organizations
• 1,500 hospitals with CoC-accredited cancer
  programs
• Network of more than 1,600 volunteer Cancer
  Liaison Physicians
• ACOSOG CoC Goals
• To establish, disseminate and monitor new
  clinical practice standards based on emerging
  clinical trial evidence
• To develop and implement skills verification
  programs
• To serve as research arm of ACS including for
  emerging technologies

10
What do we do?
11
Mission

• ACOSOG is dedicated to improving the care of the
  surgical oncology patient
• Increase response and cure rates
• Reduce morbidities and disabilities
• Better understand the biologic basis of
  early-stage disease and its treatment

12
Theme 1

• Investigate novel surgical and targeted therapies
  to maintain oncologic outcomes while reducing
  toxicities and disabilities
• Key Scientific Highlights Z9001, Z0030, Z0011
• Test molecular and imaging profiling to enhance
  the accuracy of risk stratification
• Apply neoadjuvant therapies to improve overall
  response rates and monitor individual responses

13
Novel Targeted Therapy Z9001
Recurrence free survival
Recurrence-free andalive ()
Plt0.0001
Months
Lancet 2009
14
Novel Surgical Therapy Z0030
Overall survival
Survival ()
P0.531
Survival (years)
AATS 2010
15
Novel Surgical Therapy Z0030
Disease-free survival
Survival ()
P0.655
Survival (years)
AATS 2010
16
Overall Survival by Treatment Arm
Novel Surgical Therapy Breast/Z0011
Alive ()
Median follow-up 6.3 yr
P0.25
Years
ASCO 2010
17
Theme 2

• Investigate novel surgical and targeted therapies
  to maintain oncologic outcomes while reducing
  toxicities and disabilities
• Test molecular and imaging profiling to enhance
  the accuracy of risk stratification
• Key Scientific Highlights Z9001, Z0010, Z0040
• Apply neoadjuvant therapies to improve overall
  response rates and monitor individual responses

18
RFS For Exon 11-Mutant Cases by Arm
Molecular Profiling Z9001
RFS For Wildtype Cases by Arm
Recurrence-free andalive ()
Imatinib (n173) Placebo (n173)
Imatinib (n32) Placebo (n32)
Treatment
Treatment
Plt0.0001 at 24 months
P0.6123 at 24 months
Months
ASCO 2010
19
Overall Survival by Bone Marrow Status
Molecular Profiling Z0010
Alive ()
P0.01
Years
ASCO 2010
20
Survival by SLN Status
Molecular Profiling Z0010
Alive ()
P0.64
Years
ASCO 2010
21
Molecular Profiling Z0040
Overall survival
Alive ()
HE (-) LN
IHC ()
IHC (-)
Survival (years)
22
Theme 3

• Investigate novel surgical and targeted therapies
  to maintain oncologic outcomes while reducing
  toxicities and disabilities
• Test molecular and imaging profiling to enhance
  the accuracy of risk stratification
• Apply neoadjuvant therapies to improve overall
  response rates and monitor individual responses
• Key Scientific Highlights Z6041, Z1031

23
Neoadjuvant Therapies GI / Z6041

• Significance
• Highest path CR rate (43) reported for early
  rectal cancer
• Near 100 margin negative LE rate
• Successor trial reduce toxicity improve pCR
  rate

ASCO 2010
24
Neoadjuvant Therapies Breast/Z1031
51 converted to breast conserving surgery
Prior to aromatase inhibitor
After aromatase inhibitor
ASCO 2010
25
Z1031 Specimen Acquisition, Processing and
Analysis
26
Z1031 Specimen Acquisition, Processing and
Analysis
27
Z1031 Specimen Acquisition, Processing and
Analysis
28
Z1031 Specimen Acquisition, Processing and
Analysis
29
Z1031 Specimen Acquisition, Processing and
Analysis
377 cases collected
344 reviewed261 gt 70 tumor cellularity
245 expression arrays
50 whole genome sequences
163 aCGH arrays
246 cases with high quality RNA
30
Primary tumor
Brain Metastasis
31
How do we do it?
32
Trial Monitoring and Reporting
Scientific Proposal Generation
Peer Review and Prioritization
Protocol DevelopmentTrial Implementation
33
Scientific Proposal Generation
Idea generation Scientific Committee

• Study team development of concept
• Multidisciplinary and statistical input
• External collaborations (QARC, other groups)

• Feasibility estimates
• National Cancer Database case numbers
• Network surveys MD interest
• Patient Advocacy input patient interest

34
Peer Review and Prioritization
Clinical Scientific Review Committee Translational
Science Review Committee

• Central Specimen Bank and Pathology Committee
• Basic and Translational Science Committee
• Opportunities biospecimen acquisition, basic and
  correlative studies

• Scientific Steering Committee
• Prioritization portfolio and resource balance

35
Protocol Development/Trial Implementation
NCI Steering Committee review

• Protocol development
• Protocol Editor
• Study Team
• Statistics

Engagement of ACOSOG networks
36
Trial Monitoring - Suite of Tools
37
Surgical QA/QC

• Technical credentialing

Ongoing Audits
Surgical endpoints
38
ACOSOG
IndividualizedResponseMonitoring
Z6051 Novel Surgical Therapies
Central Specimen Bank
Risk Stratification
39
Thank You