Robert L. Comis, MD

1) On behalf of the Coalition of Cancer Cooperative Groups
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.

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

BCRF funding has also been crucial to the performance of important correlative laboratory studies for E2100, a pivotal trial of anti-angiogenic (i.e., inhibiting growth of blood vessels) therapy in breast cancer. This trial is now closed to accrual, but patients who entered into the trial supplied serum, urine, and tumor block material. These samples were analyzed for angiogenic marker levels and are also being used to establish tumor marker profiles identifying cancers that may benefit from anti-angiogenic treatments.

The PACCT-1/TAILORx trial is another major trial in which BCRF funding is also 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 upon 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 from it.

BCRF funds are also currently being used to support initial costs associated with the submission of tissue and blood for two large phase III studies that recently opened: E5103, an adjuvant trial testing the role of anti-angiogenic therapy in early-stage breast cancer, and E1105, a 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 processing of previously 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 two hundred genes in breast cancer recurrence and response to therapy. Such analysis has the potential to revolutionize treatment of breast cancer by virtue of allowing 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.