Summary

Abstract

Dr. Fisher’s review of the events of the last 2 years from the standpoint of the NSABP illustrates graphically the complexities of performing clinical trials in the public arena. It is important to note that extensive auditing of the NSABP data set for their clinical trial of breast conservation therapy (B06) was performed by an independent company. The data were validated by this arduous investigation to a remarkable degree. The results of this audit and its review by an independent panel of experts will soon be published by the National Cancer Institute, Bethesda. The NCI held a conference in November, 1994, in which these results and the results from the other randomized trials of breast conservation therapy that formed the basis of the 1990 Consensus Development Conference recommendations were updated. With additional follow-up the same conclusion was sustained, i.e. that there was no difference in survival between women with stage I and stage II breast cancer treated by mastectomy or by breast conservation therapy (involving tumorectomy, axillary staging, and breast irradiation).