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Genomic Health And ECOG-ACRIN Cancer Research Group Announce Publication Of Positive DCIS Validation Study In The Journal Of The National Cancer Institute

"The development of the Oncotype DX DCIS Score is in direct response to recommendations of an expert panel convened by the National Cancer Institute in 2009 to develop and validate new tools to identify which women with DCIS may be spared radiation therapy and which are at greatest risk of developing invasive cancers that require more aggressive therapy, including chemotherapy," said Joseph A. Sparano, M.D., therapeutic chair of the ECOG-ACRIN Breast Cancer Committee; professor of medicine (oncology) and professor of obstetrics, gynecology, and women's health at the Albert Einstein College of Medicine; and associate chairman of the Department of Oncology at Montefiore Medical Center in Bronx, New York.

The study demonstrated that 70 percent of patients who met the eligibility criteria for participation in ECOG E5194 had a low DCIS Score and may be able to forego radiation therapy.  Compared with patients whose tumor had an intermediate or high DCIS Score, patients with a low DCIS Score had a significantly lower likelihood of a local recurrence at 10 years (about 11 percent vs. 26 percent, respectively).   In addition, a low DCIS Score was associated with a significantly lower risk of developing invasive breast cancer, which was approximately 4 percent in the low score group, 12 percent in the intermediate score group, and 19 percent in the high score group. The DCIS Score was predictive of local recurrence across patient subgroups regardless of lesion size, grade, surgical margins, or menopausal status.

"This publication adds to the growing body of evidence showing that microscopic pathology grading alone is not a reliable indicator of the risk of recurrence and the need for more intensive treatment," said Steven Shak, M.D., chief medical officer and executive vice president of research and development at Genomic Health.  "Together with the recently presented positive cost effectiveness data in DCIS, we believe these peer-reviewed published results pave the way to expand reimbursement and increase patient access to the Oncotype DX DCIS Score."

In addition to the Oncotype DX DCIS Score, Genomic Health provides the Oncotype DX Recurrence Score for patients with early-stage invasive breast cancer, which is the only clinically validated genomic test predictive of chemotherapy benefit and incorporated in major cancer treatment guidelines.

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