Robert L. Comis, MD

2009-2010 BCRF Projects:

1) On behalf of the Coalition of Cancer Cooperative Groups
(made possible with generous support from Pfizer)
BCRF funding is applied to continuation of Cancer Clinical Trial Eligibility Determination for Minority Breast Cancer Patients Using an Electronic Screening and Tracking Tool. This initiative will help researchers at minority-based community cancer programs in the US. While national rates of minority participation in clinical studies overall remain dismally low, little is known about the numbers of minority women who are screened for possible participation in breast cancer clinical trials, and the reasons why they are ineligible or choose not to participate.

Using an electronic clinical trials database (TrialCheck®) and related screening and tracking system (TrialTracker). at point-of-care, clinicians can screen patients for clinical trials and track whether the patient entered a clinical trial, and if not, the reasons why. With this data, clinicians can identify the precise barriers to participation among the patients they serve, and use the data in the formation of intervention strategies that correspond to each site's specific needs. Helping the sites increase the number of minority-based breast cancer patients who are considered for a clinical trial at the time of their diagnosis will ultimately lead to an increase in the number of patients who enter a clinical trial.

As of April 2009, eight community cancer programs have joined this program: Meharry Medical College Minority-Based Community Clinical Oncology Program, Nashville, TN; John H. Stroger, Jr. Hospital of Cook County Minority-Based Community Clinical Oncology Program, Chicago, IL; Louisiana State University Health Sciences Center Minority-Based Community Clinical Oncology Program, Shreveport, LA; Carle Cancer Center Community Clinical Oncology Program, Urbana, IL; SUNY Downstate University Minority-Based Community Clinical Oncology Program, Brooklyn, NY; Exempla Saint Joseph Hospital Community Clinical Oncology Program , Denver, CO; Howard University Cancer Center Minority-Based Community Clinical Oncology Program, Washington, DC; and Forsyth Regional Cancer Center South East Cancer Control Consortium Community Clinical Oncology Program, Winston-Salem, NC.

Mid-Year Progress Report:
Five community cancer programs are now participating in this program: John H. Stroger, Jr. Hospital of Cook County, Chicago, IL; SUNY Downstate University Minority-Based CCOP, Brooklyn, NY; Carle Cancer Center, Urbana, IL; Colorado Cancer Research Center, Exempla St. Joseph Hospital, Denver, CO; and Forsyth Regional Cancer Center, Winston-Salem, NC.

2) On behalf of the Eastern Oncology Cooperative Group
The Eastern Cooperative Oncology Group's Breast Committee, with the generous support of BCRF, continues to perform correlative laboratory studies attached to cutting-edge clinical trials. The approval by the Food and Drug Administration (FDA) of bevacizumab (Avastin®) for use in front-line metastatic breast cancer was based largely on the ECOG E2100 trial, which the BCRF supported virtually from its inception. With the support of BCRF, the archived specimens from this trial continue to be a valuable resource for research studies.

In 2008, a research study conducted by Dr. Brian Schneider generated data supporting an association between VEGF genotype and survival as well as grade 3 or 4 hypertension when using bevacizumab in metastatic breast cancer. E4101, a trial now closed to accrual, examines whether the addition of the EGFR-blocking drug gefitinib (Iressa®) to estrogen receptor-targeting therapy (either anastrozole or fulvestrant) may augment standard therapies and prevent the development of drug resistance. BCRF supports the correlative studies which are conducted by Dr. Sunil Badve.

The PACCT-1/TAILORx trial is another major study in which BCRF funding is instrumental in the management of tissue and blood samples submitted from patients. The TAILORx trial uses modern diagnostic testing (the Oncotype DX recurrence score by Genomic Health) to analyze a piece of the breast cancer tumor and assign treatment based on the test results. This trial is one of the largest adjuvant trials ever performed. The information and tissue samples collected during the trial will be used to determine which patients would be more likely to benefit from chemotherapy, thereby reducing the use of chemotherapy in patients who are unlikely to benefit.

BCRF funds are also currently being used to support initial costs associated with the submission of tissue and blood for E1105, a large phase III trial testing the effect of anti-angiogenic therapy in combination with front-line treatment of HER2/neu-positive metastatic breast cancer. Additionally, BCRF supports the procurement of specimens from older trials and the processing of previously collected tissue and blood samples for genomic analysis and other important laboratory research studies. Genomic studies use novel technologies to analyze the role of as many as two hundred genes in breast cancer recurrence and response to therapy. Such analysis has the potential to revolutionize the treatment of breast cancer by virtue of allowing individualization of patient therapy.

Mid-Year Progress Report:
The approval by the Food and Drug Administration of bevacizumab (Avastin®) for use in front-line metastatic breast cancer was based largely on the ECOG E2100 trial, which the BCRF supported virtually from its inception. With the support of BCRF, the archived specimens from this trial continue to be a valuable resource for research studies.

Additional studies are ongoing. E4101, a trial now closed to accrual, examines whether the addition of the EGFR-blocking drug gefitinib (Iressa®) to estrogen receptor–targeting therapy (either anastrozole or fulvestrant) may augment standard therapies and prevent the development of drug resistance. The BCRF supports the correlative studies, which are conducted by Dr. Sunil Badve.

The PACCT-1/TAILORx trial is another major trial in which BCRF funding is instrumental in the management of tissue and blood samples submitted from patients. The TAILORx trial uses modern diagnostic testing (the Oncotype DX recurrence score by Genomic Health) to analyze a piece of the breast cancer tumor and assign treatment based on the test results. This trial is one of the largest adjuvant trials ever performed. The information and tissue samples collected during the trial will be used to determine which patients would be more likely to benefit from chemotherapy, thereby reducing the use of chemotherapy in patients who are unlikely to benefit.

BCRF funds were also used to support initial costs associated with the submission of tissue and blood for E1105, a large phase III trial testing the effect of antiangiogenic therapy in combination with front-line treatment of HER2/neu-positive metastatic breast cancer. BCRF support is instrumental in the procurement of specimens from older and ongoing trials and the processing of collected tissue and blood samples for genomic analysis and other important laboratory research studies. Genomic studies use cutting-edge, highly novel technologies to analyze the role of as many as 200 genes in breast cancer recurrence and response to therapy. Such analysis has the potential to revolutionize the treatment of breast cancer by virtue of allowing the individualization of patient therapy.

Bio:
Robert L. Comis, MD, President and Chairman of the Coalition of National Cancer Cooperative Groups, Inc., is Professor of Medicine and Director of the Drexel University Clinical Trials Research Center, Philadelphia, and the Group Chair of the Eastern Cooperative Oncology Group (ECOG).

A leader in national clinical trials research since 1977, Dr. Comis has been actively involved in increasing the awareness of the pivotal role cancer clinical trials has in cancer treatment. Dr. Comis was appointed Chair, Clinical Trials Team of the NDC and was elected to the Board of the American Society of Clinical Oncology (ASCO), the American Radium Society (ARS) and the National Coalition for Cancer Research (NCCR). Dr. Comis is a Diplomat of the American Board of Internal Medicine, a member of the International Program Committee of the American Radium Society, and Chairman of the Nominating Committee of the American Association for Cancer Research, Inc.