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ACRIN Annual Meeting

ACRIN Annual Meeting. OVERVIEW OF ECOG Robert L. Comis, M.D. Chair Eastern Cooperative Oncology Group September 22, 2011. ECOG Constitution Mission Statement.

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ACRIN Annual Meeting

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  1. ACRIN Annual Meeting OVERVIEW OF ECOG Robert L. Comis, M.D.ChairEastern Cooperative Oncology Group September 22, 2011

  2. ECOG Constitution Mission Statement The Eastern Cooperative Oncology Group (ECOG) is a multidisciplinary organization devoted to the prevention, treatment and study of neoplastic disease that will eventually lead to the control and cure of cancer. 1

  3. Organizational Structure Academic Members CCOP Members Group Chair Vice Chair Group Statistician Research & Education Foundation Group Chair’s Office Operations Office Statistical Center Administrative Committees Principal Investigators Scientific Committees Academic Members Disease Committees Other Scientific Committees Affiliates 2

  4. Scientific and Administrative Senior Leadership • Chair – Dr. Robert Comis • Vice Chair – Dr. Peter O’Dwyer • Group Statistician – Dr. Robert Gray • Executive Officer – Dr. Bruce Giantonio • Associate Chair – Dr. Joseph Sparano • Coordinating Center Co-Directors – Ms. Jean MacDonald and Ms. Mary Steele • Director of Operations – Ms. Donna Marinucci • Regulatory Officer – Dr. Robert Catalano 3

  5. Main Academic Member Institutions U10Funded Albert Einstein Cancer Center Beth Israel Deaconess Medical Center Cancer Institute of New Jersey Case Western-MetroHealthMedical Center Fox Chase Cancer Center Indiana University Medical Center Johns Hopkins University Mayo Clinic Northwestern University University of Pennsylvania University of Pittsburgh University of Wisconsin Vanderbilt University Non-U10 Main Members Emory University School of Medicine Instituto de EnfermedadesNeoplasicas (Lima, Peru) Ireland Cooperative Oncology Research Group New York University Medical Center Stanford University The Penn State Cancer Institute Tufts Medical Center University of Alabama University of Miami 4

  6. Primary CCOPs • Colorado Cancer Research Program CCOP • Cook County MBCCOP* • Evanston Hospital CCOP • Kalamazoo CCOP • Main Line Health CCOP • Marshfield Clinic CCOP • Medical College of Georgia MBCCOP* • Meharry Medical College MBCCOP* • Metro-Minnesota CCOP • Ochsner CCOP • Oklahoma CCOP • San Juan MBCCOP* • SUNY Downstate MBCCOP* • St Vincent Hospital Regional Center CCOP *Minority Based CCOP 5

  7. Administrative and Scientific Organizational Structure Administrative Committees - Audit - CRA - Data Monitoring - Executive Review - Nominating - Oncology Nursing - Patient Representative - Pharmacy - Radiation Oncology - Surgery Scientific Committees Disease Committees Other Scientific Committees - Breast - Laboratory Science - Gastrointestinal and Pathology - Genitourinary - Developmental Therapeutics - Head and Neck - Pathology Coordinating - Leukemia Office/Reference Laboratory - Lymphoma - Central Immunologic - Melanoma Monitoring Laboratory - Myeloma - Leukemia Laboratory - Thoracic - Cytogenetics DCP Funded Committees: - Patient Outcomes, Survivorship and Underserved - Prevention - Symptom Management 6

  8. AccrualRegistrations to Therapeutic Studies 9073 6975 8574 5737 5220 4465 5042 3450 3157 (Average) (Projected) 7

  9. CTSU Participation 2004-2009 8

  10. Major Accomplishments • Six studies led to new standard of care and FDA indications • Bevacizumab in metastatic colon (E3200), lung (E4599), breast (E2100) • Rituximab in indolent (E1496) and aggressive lymphoma (E4494) • Thalidomide in multiple myeloma (E1A00) • Two phase III adjuvant trials: • E5103 – bevacizumab + chemotherapy in HER2-negative breast cancer • E1505 – bevacizumab + chemotherapy in stage IB – IIIA NSCLC 9

  11. Major Accomplishments • Head and Neck cancer: defined prognostic and predictive roles of p53 mutations and HPV+ • AML: established superiority of high dose daunorubicin induction • Adult ALL: defined new adverse cytogenetic parameters • Breast cancer: described VEGF SNPs related to response and toxicity; and potential new therapeutic targets (eg, GRB-7) • Multiple Myeloma: established superiority of low dose dexamethasone plus lenalidomide in induction therapy 10

  12. Publication Record (2004-2008) 11

  13. Peer-Review Funding: 2004-2008 • Laboratory Science and Pathology Committee (LSPC) • Reviews, comments on and approves all ECOG related grant studies prior to submission • 22 R01 and R21 proposals were reviewed and approved by LSPC • 50% of RO1 and R21 submissions were funded by NIH 12

  14. Peer-Review Funding: 2004-2008 NIH Total 29 R01 21*/29 (72%) *8/14 correlative research grants R21/Other 8/29 (28%) Other Breast Cancer Research Foundation 2 Susan B. Komen Foundation 1 American Cancer Society 1 Lymphoma Research Foundation 1 Leukemia and Lymphoma Society 2 13

  15. Major Accomplishments • Key components of our Translational Science effort • Laboratory Science and Pathology Committee • PCO-RL and other core laboratories • Developmental Therapeutics Committee • Pharmacogenetics subcommittee studies • Leukemia Laboratory Committee and Leukemia Translational Research Laboratory • Translational Science Team • IT infrastructure 14

  16. Major Accomplishments • Established scientific infrastructure to perform large-scale biomarker driven studies • Launched two large marker-driven phase III studies • E5202 – stage II colon cancer (MSI; 18q LOH) • TAILORx (PACCT-1) – node negative breast cancer (Oncotype-DX) 15

  17. E5202 Trial Schema Low-Risk Patients MSS or MSI-L with retention of 18q alleles MSI-H Arm A: mFOLFOX6 q2w × 12 Arm B: mFOLFOX6 + bevacizumab* q2w × 12 Arm C: Observation only High-Risk Patients MSS/18q LOH or MSI-L/18q LOH are RANDOMIZED Stratify: Disease stage (IIA or IIB) Microsatellite stability (stable vs MSI) 18q LOH MSI-L = low-level microsatellite instability MSI-H = high-level microsatellite instability *bevacizumab continued for an additional 6 months 16

  18. Integral Biomarker Specimen Flow—E5202 Fax results - avg 4 working days 5 working days Site registers patient, ships 2 blocks (1 tumor, 1 normal) PCO-RL * Laboratory QC and Processing MDACC* tests for 18qLOH, MSI Surgery 60 days max ECOG Rando Fax results - avg 4 working days Site registers patient to Treatment * CAP-accredited lab for CLIA-88 compliance 17

  19. General Themes for the Future • Study “targeted” therapies with the ultimate goal of developing new potentially curative strategies • Define new predictive and prognostic factors which lead to hypothesis driven clinical trials • Continue to develop both laboratory-based and IT infrastructure • Build upon new data from existing pivotal studies undergoing completion and analysis 19

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