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Positive results from Genomic Health's Oncotype DX study in breast cancer patients with node-positive disease

Published on December 11, 2009 at 1:05 AM · No Comments

Genomic Health, Inc. (Nasdaq: GHDX) today announced that The Lancet Oncology published positive results from a study of Oncotype DX(®) in postmenopausal women with node-positive, estrogen receptor-positive breast cancer conducted by the Southwest Oncology Group (SWOG), a National Cancer Institute-supported clinical trials cooperative group. The Lancet Oncology published these results online as an "early release" to coincide with additional data analyses reinforcing that the Oncotype DX breast cancer test can help predict chemotherapy benefit in breast cancer patients with node-positive disease. These data, presented today as a late-breaking poster during a discussion on multigene assays at the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium (Abstract #112), support the clinical utility of Oncotype DX in this patient population.

The study published in The Lancet Oncology challenges the current treatment standard of adjuvant chemotherapy for all women with lymph node-positive breast cancer.

"These studies indicate that the Oncotype DX Recurrence Score(®) result can provide beneficial clinical information beyond standard pathology testing for node-positive breast cancer patients," said Kathy S. Albain M.D., Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Loyola University Chicago Stritch School of Medicine, Cardinal Bernardin Cancer Center, Loyola University Health System, Maywood, Il, and senior author of the study. "With the right chemotherapy regimen, we can favorably impact survival; but it is also important to avoid the toxicity and medical costs of chemotherapy when it may not be needed for patients whose tumors have a distinct biology not responsive to standard 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>

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