High-Dose Chemotherapy/ Bone Marrow Transplant

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High-Dose Chemotherapy/ Bone Marrow Transplant Studies for Breast Cancer
The National Cancer Institute (NCI) is sponsoring studies of the effectiveness of high- dose chemotherapy and autologous bone marrow or stem cell transplantation in the treatment of breast cancer. Preliminary results of two of these will be presented at the May meeting of the American Society of Clinical Oncology (ASCO). The results of two similar foreign studies will also be presented at the meeting.

Because of the importance of these studies, the NCI is eager that the results be made public as soon as possible. In February, NCI called together a group to determine how soon data analysis could be completed and the preliminary findings released. The meeting was attended by representatives of the institute, ASCO, the U.S. investigators, and several patient advocacy organizations.

After discussing a full range of issues, particularly the importance of data accuracy and completeness, the group decided that more work was needed before results would be ready for release. Joining in this opinion were the representatives of the patient advocacy organizations.

The NCI recognizes the need for women and physicians to have information that will reliably guide treatment choices. Clearly, proper validation and full analysis of the data must be completed before the results can be used in making treatment decisions.

The imperative need for information about the benefits of various treatments can only be satisfied by well-designed and well-conducted clinical trials. A final but absolutely necessary aspect of clinical trials is the need to assure the correctness of data and the soundness of their analysis.

The investigators are now in this final phase: assuring that the data and the analysis are correct and complete. The results of this analysis have not been provided to NCI. NCI expects that preliminary analysis will be completed by April 15 and made available at that time. Data that have been more fully analyzed will be presented at the ASCO meeting.