139th National Cancer Advisory Board
unworkable; and (6) patients require the answers to many questions and the education process is extensive.
Dr. Chabner asked how the TCGA information would be used to look at outcomes. Dr. Barker explained that TCGA would create the databases, and scientists and clinicians will be able to begin asking those kinds of questions. She noted, however, that one of TCGA tumor choices is from a well- orchestrated clinical trial so it will be possible to take that data and work back to outcomes. Moreover, different portals are envisioned for the Atlas, and it is hoped there will be groups of clinicians who make up different portals for the data so that questions can be asked and answered in real time about some of the kinds of trials that will be part of the Atlas. Dr. Freedman stated that he has had reservations about the ELPI issues related to TCGA, and he expressed the view that the data must be de-linked, not anonymized, to be of value. He asked how the ELPI issues were being addressed. Dr. Barker explained that they currently are being dealt with at the levels of the NCI through the implementation of its First Generation Guidelines for Biorepositories and the NIH through a couple of projects, one called the Gene Environment Interaction Project. Guidelines from the NIH project were recently published in the Federal Register. Dr. Barker noted that, initially, a limited or two-tier access to TCGA data will be necessary, that opening access in the future will require action at the Department or Congressional level, and that the scientific community will have a chance to respond.
TAMOXIFEN AND STAR TRIAL RESULTS—DRS. LESLIE FORD AND LARRY WICKERHAM
Dr. Leslie Ford, Acting Deputy Director, Division of Cancer Prevention (DCP), reminded members of the initial report in 1998 of the National Surgical Adjuvant Breast and Bowel Project (NSABP) tamoxifen trial, NCI’s first breast cancer prevention initiative. That trial compared tamoxifen to placebo and led to the first FDA approval of a drug for risk reduction in women at increased risk for breast cancer.
The Study of Tamoxifen and Raloxifene (STAR) was the second prevention trial and was reported in 2005 at ASCO and in the Journal of the American Medical Association. She introduced Dr. Lawrence Wickerham, Associate Chairman, NSABP, and Associate Professor of Human Oncology, Drexel University School of Medicine at Pittsburgh, to present an update on the NSABP breast cancer prevention program.
Dr. Wickerham reminded members that the NSABP is now close to a 50-year history of conducting cooperative group studies in the treatment of breast and bowel cancers, and these have had a major impact on the standard of care in those diseases. NSABP trials were largely responsible for the transition from true radical mastectomy to lumpectomy, and adjuvant trials have looked at therapy in node-positive and node-negative patients with ductal carcinoma in situ (DCIS).
Therapies in adjuvant trials have included both hormonal therapies and chemotherapies. The NSABP prevention network now comprises 200 sites and an additional 300 satellite centers located throughout the United States, Canada, and Puerto Rico. This includes more than 50 of the Cancer Community Oncology Program (CCOP) institutions, and they have been a key component to NSABP prevention activities. Other keys to success have been the wide distribution of sites throughout North America and the time and effort spent making certain that the quality of trial participation at these centers is distributed equally. Dr. Wickerham pointed out that American Cancer Society (ACS) figures for 2006 estimate more than 212,000 new diagnoses of invasive breast cancers and, despite improvements in treatment and screening, more than 40,000 deaths, indicating the potential for prevention to have a significant impact on the public health related to this topic.