3048365-1 american college of surgeons oncology group heidi nelson, m.d. david m. ota, m.d
TRANSCRIPT
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American College of Surgeons Oncology Group
American College of Surgeons Oncology Group
Heidi Nelson, M.D.
David M. Ota, M.D.
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Who are we?Who are we?
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ACOSOG
Operations and Membership Center
Members
Scientific Leadership
Statistics and Data Center
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Members
37%
6%
18%
4%
35%
Specialty Hospital type
37%
15%2%
46%
Medical oncology
Radiation oncology
Surgeon
CRA / nurse
Other
Teaching affiliate
Academic / university
Community
Other
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WA
OR
CA
NV
ID
UTCO
WY
MT
AZNM
TX
OK
KS
NE
SD
ND
MN
IA
MO
AR
LA
MS AL
TN
KY
IL IN OH
WIMI
PA
WVVA
NC
SC
GA
FL
NY
VT
ME
NH
CT
MA
RINJ
DE
MDDC
British Columbia, CanadaOntario, Canada
Breast IDIGs
GI IDIGsThoracic IDIGs
Key
Members – ACOSOG Networks
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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.
Scientific Leadership – Group Stability
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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.
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American College of Surgeons
• 73,000 U.S. members
• Several cancer programs or initiatives• Commission on Cancer
• National Cancer Database
• AJCC Staging
• ACOSOG
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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
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What do we do?What do we do?
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MissionACOSOG 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
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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
Theme 1
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0
20
40
60
80
100
0 6 12 18 24 30 36
Novel Targeted Therapy Z9001
P<0.0001Rec
urr
ence
-fre
e an
dal
ive
(%)
Months
Lancet 2009
Total Events
Imatinib 359 30
Placebo 354 70
Recurrence free survival
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Novel Surgical Therapy Z0030S
urv
ival
(%
)
Survival (years)
Overall survival
P=0.5310
20
40
60
80
100
0 2 4 6 8
AATS 2010
MLNS
MLND
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0
20
40
60
80
100
0 2 4 6 8 10
Novel Surgical Therapy Z0030S
urv
ival
(%
)
Survival (years)
Disease-free survival
P=0.655
MLNS
MLND
AATS 2010
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0
20
40
60
80
100
0 2 4 6 8
Ali
ve (
%)
Years
Overall Survival by Treatment Arm
ALND
No ALND
P=0.25Median follow-up: 6.3 yr
Novel Surgical Therapy Breast/Z0011
ASCO 2010
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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
Theme 2
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0
20
40
60
80
100
0 6 12 18 24 30 36
RFS For Exon 11-Mutant Cases by Arm
Rec
urr
ence
-fre
e an
dal
ive
(%)
Months
P<0.0001 at 24 months
Imatinib (n=173)
Placebo (n=173)
RFS For Wildtype Cases by Arm
Treatment TreatmentP=0.6123 at 24 months
Imatinib (n=32)
Placebo (n=32)
Molecular Profiling Z9001
ASCO 2010
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Ali
ve (
%)
Years
Overall Survival by Bone Marrow Status
P=0.010
20
40
60
80
100
0 2 4 6 8 10
Molecular Profiling Z0010
ASCO 2010
NegativePositive
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0
20
40
60
80
100
0 2 4 6 8 10Years
Survival by SLN Status
H&E and IHC NegativeH&E Negative and IHC Positive P=0.64
Molecular Profiling Z0010
ASCO 2010
Ali
ve (
%)
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0
20
40
60
80
100
0 1 2 3 4 5
H&E (-) LN
IHC (+)
IHC (-)
Molecular Profiling Z0040
Survival (years)
Overall survival
Ali
ve (
%)
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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
Theme 3
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Significance • Highest path CR rate (43%) reported for early rectal cancer • Near 100% margin negative LE rate• Successor trial – reduce toxicity & improve pCR rate
Neoadjuvant Therapies GI / Z6041
ASCO 2010
pT0 43%pT1 20%pT2 30%T2 N0
rectalcancer
by ERUSor MRI
Radiationcombined
with Capecitabine
+Oxaliplatin
T0-T2:Observation
T3 or positive margins:Further
treatment
Local
Excision
pT3 5%
Results
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Prior to aromatase inhibitor
After aromatase inhibitor
51% converted to breast conserving surgery
Neoadjuvant Therapies Breast/Z1031
ASCO 2010
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Z1031 Specimen Acquisition, Processing and Analysis
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Genome ConsentSpecimen Procurement Banking and Tracking
Pathology Review and Analysis of Cellularity
Specimen Procurement Banking and Tracking
Pathology Review and Analysis of Cellularity
Z1031 Specimen Acquisition, Processing and Analysis
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Genome ConsentSpecimen Procurement Banking and Tracking
Pathology Review and Analysis of Cellularity
Z1031 Specimen Acquisition, Processing and Analysis
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Genome ConsentSpecimen Procurement Banking and Tracking
Pathology Review and Analysis of Cellularity
Z1031 Specimen Acquisition, Processing and Analysis
Novel Genomic Predictive Models of
AI outcomeMolecular Profiling
High Quality RNA and DNA Isolation
Novel Genomic Predictive Models of AI outcome Molecular Profiling
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Genome ConsentSpecimen Procurement Banking and Tracking
Pathology Review and Analysis of Cellularity
Novel Genomic Predictive Models of
AI outcomeMolecular Profiling
High Quality RNA and DNA Isolation
Z1031 Specimen Acquisition, Processing and Analysis
377 cases collected 344 reviewed;261 > 70% tumor cellularity
245 expression arrays
163 aCGH arrays
50 whole genome
sequences
246 cases with high quality RNA
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Mark Watson9,Elaine R. Mardis1,2,4
Matthew J. Ellis3,4*
Primary tumor Brain Metastasis
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How do we do it?How do we do it?
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Scientific Proposal Generation
Peer Review and PrioritizationProtocol Development
Trial Implementation
Trial Monitoring and Reporting
OMC
SDC
Members
Scientific
Leadership
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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
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Peer Review and Prioritization
Clinical Scientific Review CommitteeTranslational Science Review Committee
Central Specimen Bank and Pathology CommitteeBasic and Translational Science Committee• Opportunities: biospecimen acquisition, basic and correlative studies
Scientific Steering Committee • Prioritization: portfolio and resource balance
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Protocol Development/Trial Implementation
NCI Steering Committee review
Protocol development •Protocol Editor•Study Team•Statistics
Engagement of ACOSOG networks
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Trial Monitoring - Suite of Tools
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Surgical QA/QC
Technical credentialing
Ongoing Audits
Surgical endpoints
Z0010Z0020Z0030Z0360Z6041Z4032Z1072Z4033Z6051
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Risk Stratification
Central Specimen
Bank
IndividualizedResponseMonitoring
ACOSOG
Z6051
Novel Surgical Therapies
Molecular ProfilingPrior to aromatase
inhibitorAfter aromatase
inhibitor
Requiresmastectomy
Z1031 Neoadjuvant Therapies
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Thank You