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Genomic Health Announces Positive Results From Large Study Of Oncotype DX® To Quantify Risk Of Loco-Regional Recurrence In Node-positive Breast Cancer Patients And Acceptance Of Oncotype DX DCIS Validation Study For Publication

REDWOOD CITY, Calif., March 13, 2013 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced positive results of a large study that demonstrates the Oncotype DX® Recurrence Score® result to be a robust predictor of loco-regional recurrence (LRR) in node-positive (N+), estrogen receptor (ER) positive patients treated with adjuvant hormonal therapy and chemotherapy.  This study, titled "Prognostic impact of the 21-gene Recurrence Score (RS) on loco-regional recurrence (LRR) of node-positive, ER-positive breast cancer patients (pts) treated with adjuvant chemotherapy: Results from NSABP B-28" was recently presented at the 2013 Society of Surgical Oncology Annual Cancer Symposium in National Harbor, Maryland.

"Gaining a better understanding of the patient's individual risk of loco-regional recurrence can assist physicians in determining the most appropriate comprehensive treatment plan," said Terry Mamounas, M.D., Medical Director, Comprehensive Breast  Program, MD Anderson Cancer Center Orlando, and member of the National Surgical Adjuvant Breast and Bowel Project (NSABP) board.  "These new data show that for ER-positive lymph node-positive breast cancer patients, Oncotype DX not only helps identify those who will have excellent outcomes with adjuvant chemo-endocrine therapy, as previously reported, but it can also be useful for radiation treatment decision making."

This study analyzed tumor samples from 1,065 hormone receptor-positive, node-positive breast cancer patients who were treated with hormonal therapy and anthracycline containing chemotherapy as part of the NSABP B-28 trial.  After a median follow-up of 11.2 years, 80 patients had local (68 percent) or regional (32 percent) recurrence. The 10-year cumulative incidence of loco-regional recurrence was 3.3 percent  for patients with a low Recurrence Score result, 7.2 percent for those with an intermediate Recurrence Score result, and 12.3 percent  for those with high Recurrence Score result (p<0.001), demonstrating that the Recurrence Score was significantly associated with the risk of loco-regional recurrence.  These new findings may have clinical implications in node-positive patients treated with adjuvant chemo-endocrine therapy as they consider post-mastectomy chest wall or regional nodal radiotherapy, and post-lumpectomy regional nodal radiotherapy.

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