139th National Cancer Advisory Board
diseases as well. He noted the concern that has been expressed regarding the group differences in the DCIS results in this trial and what the biology might be. He asked whether the estrogen receptor status of the DCIS lesions had been investigated and whether there had been an analysis to characterize the differences between the two groups. Dr. Wickerham replied that the groups had not been analyzed for differences, but the tumors are on hand and an analysis could be done. He alluded to the fact that there was a review of the histologic characteristics of the tumor from the original pathology report, with no excess of necrosis, and surmised that there would be the expected 75/25 split. Dr. Cowan asked whether any differences in the prognostic features of the invasive tumors were identified in the characteristics review. Dr. Wickerham stated that all of the histologic characteristics have not yet been analyzed, but the staging criteria suggest no difference. Dr. Cowan referred to the concern that AIs and SERMs may not be best when used in combination and questioned the choice of the combination in the P-4 study as opposed to a sequential use in the prevention. Dr. Wickerham clarified that the schema calls for raloxifene plus a letrozole/placebo and raloxifene or letrozole plus a raloxifene/placebo, so participants are on either the AI or the SERM.
Dr. Cowan observed that in the original trial the 5 years of tamoxifen regimen was based on adjuvant data that were carefully worked out by NSABP, but data for an additional 5 years do not exist. He asked whether there are plans for studying that. Dr. Wickerham replied that a formal study is not planned, but data exist in the osteoporosis setting for women taking the drug in a structured way through 8 years. No impact or detrimental effect to the bone was identified, nor were there unexpected or cumulative toxicities, and the benefits relative to breast cancer risk reduction were continued; so extrapolation would be necessary to find an answer. Dr. Runowicz observed that the results of P-2 STAR make raloxifene sound like an ideal preventive strategy but the Ruth trial and the editorial about raloxifene suggest that a better, safer drug may be needed, and she asked for comment. Dr. Wickerham briefly reviewed the design hypothesis and study results of the Ruth trial and expressed the view that the STAR results suggest that if a population at low risk for thromboembolic disease is selected as P-4 proposes, overall risk can be reduced, as well as death due to stroke. This becomes part of the risk/benefit equation and needs to be part of that informed consent process. Dr. Chabner alluded to the past concern about the possibility that the strokes and the increased thrombotic events occurred in a subset of women who had a predisposition because of inherited deficiencies in their anticoagulant factors, and he asked whether this threat had materialized. Dr. Wickerham replied that some of the serum and lymphocyte bank material was used to look at Factor V and prothrombin mutation. The finding was that Factor V and prothrombin did increase the risk of clot, but they increased it independent of tamoxifen. The risk increased in both groups equally and there was no justification for screening for those abnormalities for women receiving tamoxifen, either for prevention or for treatment, which would have even a greater impact.
ADOLESCENT AND YOUNG ADULT ONCOLOGY REPORT—MS. CHERI NICHOLS AND DRS. BARRY ANDERSON, KAREN ALBRITTON, AND MICHAEL CALGIURI
Ms. Cherie Nichols, Director, Office of Science Planning and Assessment (OSPA), OD, reminded members that the OSPA has led a number of PRGs, and she introduced members of the Adolescent and Young Adult Oncology (AYAO) PRG to present its report entitled “Closing the Gap: Research and Care Imperatives for Adolescents and Young Adults with Cancer.” She observed that the themes of the report coincide with earlier discussions about the need for making a difference in this disease, continuing to provide scientific leadership, developing trans-community efforts, and ensuring access. The need for a PRG for this age group was proposed a year ago to Dr. Andrew von Eschenbach, then-Director, NCI, by Mr. Doug Ulman, Liaison Representative, Director’s Consumer Liaison Group (DCLG). His proposal was accompanied by an offer from the Lance Armstrong Foundation (LAF) to match NCI funding for the effort. Presenters of the AYAO PRG report are: Dr. Barry Anderson, PRG Executive Director, and