Assay Quantifies Risk of Breast Cancer Recurrence

A study has shown that a novel multi-gene assay can accurately and precisely quantify the likelihood of breast cancer recurrence in a large segment of newly diagnosed patients. These results were presented at the annual San Antonio Breast Cancer Symposium (TX, USA).

The study was conducted by the U.S. National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health, Inc. (Redwood City, CA, USA), which developed the assay. Using NSABP's extensive patient database, NSABP and Genomic Health designed a blinded, prospective validation using surgical samples from 668 patients, who were node-negative, ER-positive, and tamoxifen-treated. These tissue samples were from patients who enrolled in NSABP's clinical trial from 1982-88 and whose outcomes have been tracked over time. Using RNA analysis of tumor tissues, the study evaluated the assay to determine the likelihood of breast cancer recurrence.

The results showed that the recurrence score determined by the assay provided a level of correlation to breast cancer that exceeded standard measures, such as patient age, tumor size, and tumor grade. The study used thin sections from standard diagnostic pathology specimens (fixed paraffin-embedded tissue) that are routinely available. The study also showed that using multiple genes is more powerful than using single genes. The panel included genes related to the estrogen receptor, to HER2, to proliferation, and to invasion as well as several other categories.
practical advance in breast cancer diagnosis because the assay uses tumor tissue that is routinely obtained and stored for every patient,” said Norman Wolmark, M.D., chair of the NSABP and the
"We are excited about the results of this trial, which represents a department of human oncology at Allegheny General Hospital in Pittsburgh (NSABP, PA, USA).




Related Links:
Genomic Health
Allegheny General Hospital in Pittsburgh