DOI: 10.1097/01.COT.0000287948.60452.a4
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Issn Print: 0276-2234
Publication Date: 2005/04/10
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Excerpt
In the case of the European-led MINDACT trial, the design was substantially altered at a steering committee meeting in St. Gallen, Switzerland, this winter.
The researchers involved in both trials have already demonstrated through retrospective analyses that both microarray tests—one based on a 70-gene signature and one based on a 21-gene signature—can accurately identify women with early node-negative breast cancer who are at low risk of recurrence.
The data from these studies, reported at the San Antonio Breast Cancer Symposium (OT's 2/10/05 issue has an article about the 21-gene signature study), indicate that a significant portion of women can safely avoid chemotherapy, without increasing their risk of relapse.
With the retrospective confirmatory data in hand, both teams are poised to test their assays in a prospective setting. The goals and designs of the two trials are slightly different, say experts, but both will determine whether the tests have prognostic or predictive value in the clinic.
Furthermore, experts say the trials will provide critically important resources for the development and refinement of subsequent tests.
“If you have a randomized group, you can go back retrospectively, as long as you save the biological materials, which both trials are going to be doing, and learn a whole lot more about which patients benefit from which treatment,” said Larry Norton, MD, Deputy Physician-in-Chief for Breast Cancer Programs and the Norna S. Sarofim Chair in Clinical Oncology at Memorial Sloan-Kettering Cancer Center.
Access to such data will be invaluable because of the rapid evolution of the field. “When these studies are completed, the molecular understanding of prognostic features in breast cancer will be extremely different from right now when the studies are being designed,” he predicted.
