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American College of Surgeons Oncology Group

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  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. Members Medical oncology Surgeon Academic / university Radiation oncology CRA / nurse Community Other Other Teaching affiliate Specialty Hospital type 6% 2% 15% 18% 4% 46% 37% 37% 35%

  5. WA ME MT ND VT OR MN NH MA ID SD WI NY WY MI CT RI IA PA NV NJ NE OH IN DE IL UT CO WV MD CA VA KS MO DC KY NC TN AZ OK AR SC NM GA AL MS TX LA FL • Members – ACOSOG Networks British Columbia, Canada Ontario, Canada Key Breast IDIGs GI IDIGs Thoracic IDIGs

  6. Scientific Leadership – Group Stability

  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. Total Events Imatinib 359 30 Placebo 354 70 Novel Targeted Therapy Z9001 Recurrence free survival Recurrence-free andalive (%) P<0.0001 Months Lancet 2009

  14. MLNS MLND Novel Surgical Therapy Z0030 Overall survival Survival (%) P=0.531 Survival (years) AATS 2010

  15. MLNS MLND Novel Surgical Therapy Z0030 Disease-free survival Survival (%) P=0.655 Survival (years) AATS 2010

  16. Overall Survival by Treatment Arm ALND No ALND Novel Surgical Therapy Breast/Z0011 Alive (%) Median follow-up: 6.3 yr P=0.25 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 (n=173) Placebo (n=173) Imatinib (n=32) Placebo (n=32) Treatment Treatment P<0.0001 at 24 months P=0.6123 at 24 months Months ASCO 2010

  19. Overall Survival by Bone Marrow Status Negative Positive Molecular Profiling Z0010 Alive (%) P=0.01 Years ASCO 2010

  20. Survival by SLN Status H&E and IHC Negative H&E Negative and IHC Positive Molecular Profiling Z0010 Alive (%) P=0.64 Years ASCO 2010

  21. Molecular Profiling Z0040 Overall survival Alive (%) H&E (-) 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. Results T0-T2: Observation L o c a l E x c i s i o n pT0 43% pT1 20% pT2 30% T2 N0 rectal cancer by ERUS or MRI Radiation combined with Capecitabine + Oxaliplatin T3 or positive margins: Further treatment pT3 5% 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. Specimen Procurement Banking and Tracking Pathology Review and Analysis of Cellularity Genome Consent Z1031 Specimen Acquisition, Processing and Analysis

  26. Specimen Procurement Banking and Tracking Specimen Procurement Banking and Tracking Pathology Review and Analysis of Cellularity Pathology Review and Analysis of Cellularity Genome Consent Genome Consent Z1031 Specimen Acquisition, Processing and Analysis

  27. Specimen Procurement Banking and Tracking Pathology Review and Analysis of Cellularity Genome Consent High Quality RNA and DNA Isolation Novel Genomic Predictive Models of AI outcome Molecular Profiling Z1031 Specimen Acquisition, Processing and Analysis

  28. Specimen Procurement Banking and Tracking Pathology Review and Analysis of Cellularity Genome Consent High Quality RNA and DNA Isolation High Quality RNA and DNA Isolation Novel Genomic Predictive Models of AI outcome Novel Genomic Predictive Models of AI outcome Molecular Profiling Molecular Profiling Z1031 Specimen Acquisition, Processing and Analysis

  29. Specimen Procurement Banking and Tracking Pathology Review and Analysis of Cellularity Genome Consent High Quality RNA and DNA Isolation Novel Genomic Predictive Models of AI outcome Molecular Profiling Z1031 Specimen Acquisition, Processing and Analysis 377 cases collected 344 reviewed;261 > 70% tumor cellularity 245 expression arrays 50 whole genome sequences 163 aCGH arrays 246 cases with high quality RNA

  30. Matthew J. Ellis3,4* Mark Watson9, Elaine R. Mardis1,2,4 Primary tumor Brain Metastasis

  31. How do we do it?

  32. Members OMC Scientific SDC Leadership 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. Technical credentialing Z0010 Z0020 Z0030 Z0360 Z6041 Z4032 Z1072 Z4033 Z6051 Surgical QA/QC • Ongoing Audits • Surgical endpoints

  38. ACOSOG Z1031 Neoadjuvant Therapies Requires mastectomy Prior to aromatase inhibitor After aromatase inhibitor Molecular Profiling IndividualizedResponseMonitoring Z6051 Novel Surgical Therapies Central Specimen Bank Risk Stratification

  39. Thank You