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Genomic Health Announces Publication of Study of Oncotype DX(R) in Node-Positive Breast Cancer That Identifies Patients Who Do Not Appear to Benefit From Chemotherapy
Date:12/10/2009

ard chemotherapy."

For the study published in The Lancet Oncology, researchers analyzed 367 tumor samples from node-positive, estrogen receptor-positive breast cancer patients who participated in the SWOG/Breast Cancer Intergroup of North America trial that evaluated CAF chemotherapy followed by tamoxifen versus tamoxifen-alone, to determine the prognostic and predictive effects of the Oncotype DX Recurrence Score.

The Recurrence Score was highly prognostic in the tamoxifen-alone arm (p=0.006) and demonstrated predictive ability in those patients treated with chemotherapy followed by tamoxifen. Specifically the study found no chemotherapy benefit in the low Recurrence Score group (log-rank p=0.97; HR=1.02); however, there was significant disease-free survival improvement for the high Recurrence Score group (log-rank p=0.03; HR=0.59).

"Since these data were originally presented in 2007, I have used Oncotype DX to help make treatment recommendations for select node-positive patients in my clinical practice," said Eric Winer, M.D., Chief, Division of Women's Cancers at Dana-Farber Cancer Institute and Professor of Medicine at Harvard Medical School. "It is imperative that we bring our new molecular insights into clinical practice so that we can optimize and individualize treatment for every patient with breast cancer."

Additional data analyses presented at the CTRC-AACR San Antonio Breast Cancer Symposium today reinforced the conclusion that chemotherapy does not appear to benefit patients with either 1-3 or 4 or more positive nodes for disease-free survival over 10 years, if their tumors have a low Recurrence Score. There was no breast cancer specific survival (BCSS) benefit from chemotherapy in either the low (log-rank p=0.56) or intermediate (log-rank p=0.89) Recurrence Score categories; however, chemotherapy resulted in superior BCSS in the high Recurrence Score category (log-rank p=0.033).


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SOURCE Genomic Health
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