Breast cancer assay quantifies likelihood of breast cancer recurrence in study.

2004 JAN 1 - (NewsRx.com & NewsRx.net) -- The National Surgical Adjuvant Breast and Bowel Project (NSABP) and Genomic Health, Inc., announced that their large, prospective trial met its defined endpoints and validated that Genomic Health's unique breast cancer assay can accurately and precisely quantify the likelihood of breast cancer recurrence in a large segment of newly diagnosed breast cancer patients.

The study also showed that the "recurrence score" determined by the assay provides a level of correlation to breast cancer recurrence and performance that exceeds standard measures, such as patient age, tumor size and tumor grade.

These results, which were presented at the 26th Annual San Antonio Breast Cancer Symposium, are the first large-scale, multi-center validation of a multi-gene assay.

It is also the first time that such a study has been conducted using thin sections from standard diagnostic pathology specimens (fixed paraffin-embedded tissue) that are routinely available.

"We are excited about the results of this trial, which represent a practical advance in breast cancer diagnosis because the assay uses tumor tissue that is routinely obtained and stored for every patient," said Norman Wolmark, MD, chair of the NSABP, and the Department of Human Oncology at Allegheny General Hospital in Pittsburgh, Pennsylvania.

"Based on our studies, the recurrence score becomes as important a prognostic measure for this group of node-negative patients as nodal status is for all patients," said Dr. Wolmark.

Using NSABP's extensive patient database, NSABP and Genomic Health designed a blinded, prospective validation using surgical tissue samples from 668 patients, who were node-negative, ER-positive and tamoxifen-treated.