Eastern cooperative oncology group ACRIN Annual Meeting OVERVIEW OF ECOG Robert L. Comis, M.D. Chair...

eastern cooperativeeastern cooperative oncology grouponcology group

ACRIN Annual MeetingACRIN Annual MeetingACRIN Annual MeetingACRIN Annual Meeting

OVERVIEW OF ECOGOVERVIEW OF ECOG

Robert L. Comis, M.D.Robert L. Comis, M.D.ChairChair

Eastern Cooperative Oncology GroupEastern Cooperative Oncology Group

September 22, 2011September 22, 2011

eastern cooperative oncology groupeastern cooperative oncology group

ECOG Constitution Mission StatementECOG Constitution Mission StatementECOG Constitution Mission StatementECOG Constitution Mission Statement

The Eastern Cooperative Oncology Group (ECOG) The Eastern Cooperative Oncology Group (ECOG) is a multidisciplinary organization devoted to the is a multidisciplinary organization devoted to the

prevention, treatment and study of neoplastic prevention, treatment and study of neoplastic disease that will eventually lead to the control and disease that will eventually lead to the control and

cure of cancer.cure of cancer.

1


Organizational StructureOrganizational StructureOrganizational StructureOrganizational Structure

Group Group ChairChair

Vice ChairVice Chair Group Group StatisticianStatistician

Group Chair’s Office

Operations Office

Research & Education Foundation

Statistical Center

Administrative Committees

Principal Investigators Scientific

Committees

Academic Academic MembersMembers

CCOP CCOP MembersMembers

Affiliates

Academic Academic MembersMembers

Other Scientific

Committees

Disease Committees

2


Scientific and Administrative Scientific and Administrative Senior LeadershipSenior Leadership

Scientific and Administrative Scientific and Administrative Senior LeadershipSenior Leadership

Chair – Dr. Robert ComisChair – Dr. Robert Comis

Vice Chair – Dr. Peter O’DwyerVice Chair – Dr. Peter O’Dwyer

Group Statistician – Dr. Robert GrayGroup Statistician – Dr. Robert Gray

Executive Officer – Dr. Bruce GiantonioExecutive Officer – Dr. Bruce Giantonio

Associate Chair – Dr. Joseph SparanoAssociate Chair – Dr. Joseph Sparano

Coordinating Center Co-Directors – Coordinating Center Co-Directors – Ms. Jean MacDonald and Ms. Mary SteeleMs. Jean MacDonald and Ms. Mary Steele

Director of Operations – Ms. Donna MarinucciDirector of Operations – Ms. Donna Marinucci

Regulatory Officer – Dr. Robert CatalanoRegulatory Officer – Dr. Robert Catalano

3


Main Academic Member InstitutionsMain Academic Member InstitutionsMain Academic Member InstitutionsMain Academic Member Institutions

U10U10 FundedFunded

Albert Einstein Cancer CenterAlbert Einstein Cancer Center

Beth Israel Deaconess Beth Israel Deaconess Medical CenterMedical Center

Cancer Institute of New JerseyCancer Institute of New Jersey

Case Western-MetroHealth Case Western-MetroHealth Medical CenterMedical Center

Fox Chase Cancer CenterFox Chase Cancer Center

Indiana University Medical CenterIndiana University Medical Center

Johns Hopkins UniversityJohns Hopkins University

Mayo ClinicMayo Clinic

Northwestern UniversityNorthwestern University

University of PennsylvaniaUniversity of Pennsylvania

University of PittsburghUniversity of Pittsburgh

University of WisconsinUniversity of Wisconsin

Vanderbilt UniversityVanderbilt University

Non-U10 Main MembersNon-U10 Main Members

Emory University School of MedicineEmory University School of Medicine

Instituto de Enfermedades Instituto de Enfermedades Neoplasicas (Lima, Peru)Neoplasicas (Lima, Peru)

Ireland Cooperative Oncology Ireland Cooperative Oncology Research GroupResearch Group

New York University Medical Center New York University Medical Center

Stanford UniversityStanford University

The Penn State Cancer InstituteThe Penn State Cancer Institute

Tufts Medical CenterTufts Medical Center

University of Alabama University of Alabama

University of MiamiUniversity of Miami

4


Primary CCOPsPrimary CCOPsPrimary CCOPsPrimary CCOPs

Colorado Cancer Research Program CCOPColorado Cancer Research Program CCOP Cook County MBCCOP*Cook County MBCCOP* Evanston Hospital CCOPEvanston Hospital CCOP Kalamazoo CCOPKalamazoo CCOP Main Line Health CCOPMain Line Health CCOP Marshfield Clinic CCOPMarshfield Clinic CCOP Medical College of Georgia MBCCOP*Medical College of Georgia MBCCOP* Meharry Medical College MBCCOP*Meharry Medical College MBCCOP* Metro-Minnesota CCOPMetro-Minnesota CCOP Ochsner CCOPOchsner CCOP Oklahoma CCOPOklahoma CCOP San Juan MBCCOP*San Juan MBCCOP* SUNY Downstate MBCCOP*SUNY Downstate MBCCOP* St Vincent Hospital Regional Center CCOPSt Vincent Hospital Regional Center CCOP

5

*Minority Based CCOP


Administrative and Scientific Administrative and Scientific Organizational StructureOrganizational Structure

Administrative and Scientific Administrative and Scientific Organizational StructureOrganizational 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


AccrualAccrualRegistrations to Therapeutic StudiesRegistrations to Therapeutic Studies

AccrualAccrualRegistrations to Therapeutic StudiesRegistrations to Therapeutic Studies

(Projected)(Average)

0100020003000400050006000700080009000

10000

Grant Year

Reg

istr

ati

on

s

85746975

44655220

3450

9073

5737

3157

5042

7


CTSU Participation 2004-2009CTSU Participation 2004-2009CTSU Participation 2004-2009CTSU Participation 2004-2009

ECOG Participation in CTSU Menu Studies

ECOG studies on the CTSU menu 31

CTSU studies “endorsed” by ECOG 44

CTSU patients accrued to ECOG studies 11,417

ECOG patients accrued to CTSU studies 6,618

ECOG patients accrued to other intergroup studies 1,714

8


Major AccomplishmentsMajor AccomplishmentsMajor AccomplishmentsMajor Accomplishments

Six studies led to new standard of care and FDA indicationsSix studies led to new standard of care and FDA indications Bevacizumab in metastatic colon (E3200), lung (E4599), Bevacizumab in metastatic colon (E3200), lung (E4599),

breast (E2100)breast (E2100) Rituximab in indolent (E1496) and aggressive Rituximab in indolent (E1496) and aggressive

lymphoma (E4494)lymphoma (E4494) Thalidomide in multiple myeloma (E1A00)Thalidomide in multiple myeloma (E1A00)

Two phase III adjuvant trials:Two phase III adjuvant trials: E5103 – bevacizumab + chemotherapy in HER2-E5103 – bevacizumab + chemotherapy in HER2-

negative breast cancernegative breast cancer E1505 – bevacizumab + chemotherapy in stage IB – IIIA E1505 – bevacizumab + chemotherapy in stage IB – IIIA

NSCLCNSCLC

9



Head and Neck cancer: defined prognostic and Head and Neck cancer: defined prognostic and predictive roles of p53 mutations and HPV+predictive roles of p53 mutations and HPV+

AML: established superiority of high dose AML: established superiority of high dose daunorubicin inductiondaunorubicin induction

Adult ALL: defined new adverse cytogenetic Adult ALL: defined new adverse cytogenetic parametersparameters

Breast cancer: described VEGF SNPs related to Breast cancer: described VEGF SNPs related to response and toxicity; and potential new response and toxicity; and potential new therapeutic targets (eg, GRB-7)therapeutic targets (eg, GRB-7)

Multiple Myeloma: established superiority of low Multiple Myeloma: established superiority of low dose dexamethasone plus lenalidomide in dose dexamethasone plus lenalidomide in induction therapyinduction therapy

10


Publication Record (2004-2008)Publication Record (2004-2008)Publication Record (2004-2008)Publication Record (2004-2008)

JCOJCO 9393

BloodBlood 1818

NEJMNEJM 99

11


Peer-Review Funding: 2004-2008Peer-Review Funding: 2004-2008Peer-Review Funding: 2004-2008Peer-Review Funding: 2004-2008

Laboratory Science and Pathology Laboratory Science and Pathology Committee (LSPC)Committee (LSPC)

Reviews, comments on and approves Reviews, comments on and approves all ECOG related grant studies prior all ECOG related grant studies prior to submissionto submission

22 R01 and R21 proposals were reviewed and 22 R01 and R21 proposals were reviewed and approved by LSPCapproved by LSPC

50% of RO1 and R21 submissions were funded 50% of RO1 and R21 submissions were funded by NIHby NIH

12


Peer-Review Funding: 2004-2008Peer-Review Funding: 2004-2008Peer-Review Funding: 2004-2008Peer-Review Funding: 2004-2008

NIHNIH

TotalTotal 2929

R01R01 21*/29 (72%)21*/29 (72%)

*8/14 correlative research grants*8/14 correlative research grants

R21/OtherR21/Other 8/29 (28%)8/29 (28%)

OtherOther

Breast Cancer Research FoundationBreast Cancer Research Foundation 22

Susan B. Komen FoundationSusan B. Komen Foundation 11

American Cancer SocietyAmerican Cancer Society 11

Lymphoma Research FoundationLymphoma Research Foundation 11

Leukemia and Lymphoma SocietyLeukemia and Lymphoma Society 22

13



Key components of our Translational Key components of our Translational Science effortScience effort

Laboratory Science and Pathology CommitteeLaboratory Science and Pathology Committee

PCO-RL and other core laboratoriesPCO-RL and other core laboratories

Developmental Therapeutics CommitteeDevelopmental Therapeutics Committee

Pharmacogenetics subcommittee studiesPharmacogenetics subcommittee studies

Leukemia Laboratory Committee and Leukemia Leukemia Laboratory Committee and Leukemia Translational Research LaboratoryTranslational Research Laboratory

Translational Science TeamTranslational Science Team

IT infrastructureIT infrastructure

1514



Established scientific infrastructure to perform Established scientific infrastructure to perform large-scale biomarker driven studieslarge-scale biomarker driven studies

Launched two large marker-driven phase III Launched two large marker-driven phase III studiesstudies

E5202 – stage II colon cancer (MSI; 18q LOH)E5202 – stage II colon cancer (MSI; 18q LOH)

TAILORx (PACCT-1) – node negative breast TAILORx (PACCT-1) – node negative breast cancer (Oncotype-DX)cancer (Oncotype-DX)

1615


E5202 Trial Schema E5202 Trial Schema E5202 Trial Schema E5202 Trial Schema

Low-Risk PatientsMSS or MSI-L with

retention of 18q allelesMSI-H

Arm A:mFOLFOX6q2w × 12

Arm B:mFOLFOX6 + bevacizumab* q2w × 12

Arm C:Observation only

High-Risk PatientsMSS/18q LOH orMSI-L/18q LOH

areRANDOMIZED

MSI-L = low-level microsatellite instabilityMSI-H = high-level microsatellite instability*bevacizumab continued for an additional 6 months

Stratify:Disease stage

(IIA or IIB)Microsatellite stability

(stable vs MSI)18q LOH

16


Integral Biomarker Specimen Flow—E5202Integral Biomarker Specimen Flow—E5202Integral Biomarker Specimen Flow—E5202Integral Biomarker Specimen Flow—E5202

Site registers patient, ships 2 blocks (1 tumor,

1 normal)

PCO-RL * Laboratory

QC and Processing

MDACC* tests for 18qLOH,

MSISurgery

ECOG ECOG RandoRando

Site registers patient to Treatment

6600 ddaayyss mmaaxx

Fax results - avg 4 working days

Fax results - avg 4 working days

5 working days

* CAP-accredited lab for CLIA-88 compliance

17


General Themes for the FutureGeneral Themes for the FutureGeneral Themes for the FutureGeneral Themes for the Future

Study “targeted” therapies with the ultimate goal Study “targeted” therapies with the ultimate goal of developing new potentially curative strategiesof developing new potentially curative strategies

Define new predictive and prognostic factors Define new predictive and prognostic factors which lead to hypothesis driven clinical trialswhich lead to hypothesis driven clinical trials

Continue to develop both laboratory-based Continue to develop both laboratory-based and IT infrastructureand IT infrastructure

Build upon new data from existing pivotal studies Build upon new data from existing pivotal studies undergoing completion and analysisundergoing completion and analysis

19

Eastern cooperative oncology group ACRIN Annual Meeting OVERVIEW OF ECOG Robert L. Comis, M.D. Chair...

Documents

Transcript of Eastern cooperative oncology group ACRIN Annual Meeting OVERVIEW OF ECOG Robert L. Comis, M.D. Chair...