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Multiple Studies Presented at ASCO Annual Meeting Demonstrate Unique, Practice-Changing Impact of Oncotype DX to Optimize Cancer Care

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Genomic Health, Inc. (Nasdaq: GHDX) today announced results of six studies being presented at the 2014 American Society of Clinical Oncology ASCO Annual Meeting taking place May 30 – June 3 in Chicago, underscoring the practice-changing value of Oncotype DX in pre-invasive and invasive breast cancer and colon cancer.

The presentations include the first Oncotype DX DCIS Score clinical decision impact study, which showed a 31 percent change in treatment recommendations. Additionally, a direct comparison study of the Oncotype DX breast cancer test and the ROR score confirmed that the assays are not the same and that the information they provide is not equivalent.

Oncotype DX DCIS Score Changes Treatment Recommendations for One Out of Three Patients with Pre-Invasive Breast Cancer (Abstract #11050)

Ductal carcinoma in situ (DCIS), also referred to as stage 0 breast cancer, affects one out of every five women diagnosed with breast cancer in the United States and is often treated with surgery followed by radiation therapy and/or hormonal therapy. With only 20 percent of cases estimated to recur or turn into invasive breast cancer, it is estimated that about 40,000 women each year receive additional treatments that may not be needed.

“Currently, most DCIS patients are treated with surgery followed by radiation, despite the fact that no treatment beyond surgery has been shown to impact long-term survival,” said Michael Alvarado, M.D., associate professor of surgery, the University of California, San Francisco (UCSF). “These results highlight the huge need in optimizing treatment of this non-invasive, indolent form of breast disease, and the importance of the Oncotype DX DCIS Score to help physicians reduce over- and under-treatment of DCIS.”

Conducted in collaboration with Partnership for Health Analytic Research (PHAR), this multi-center study examined treatment recommendations for 115 patients from 10 sites, analyzing the change in treatment recommendations based on the Oncotype DX DCIS Score results. The study demonstrated that treatment decisions changed in 36 (31%) patients. Of the 84 patients initially recommended radiotherapy prior to Oncotype DX testing, 26 patients (31%) were recommended no radiotherapy after getting the DCIS Score result. Importantly, of the 31 patients initially recommended not to receive radiotherapy prior to Oncotype DX testing, 10 patients (32%) were reclassified towards radiotherapy after getting the DCIS Score result.

Head-to-Head Comparison Reconfirms Oncotype DX Results Are Different from Other, Prognostic-Only TestsĀ 

A comparison study in collaboration with UCSF, Marin Medical Laboratories in California, and investigators from the Athens University Medical School in Greece evaluated if the information provided by Oncotype DX and the ROR scores are equivalent. Specifically, results in 52 node-negative, post-menopausal patients revealed a very low concordance between Oncotype DX and ROR results, (correlation = 0.08, 95% CI -0.19, 0.35) highlighting the potential to misclassify patients if other assays are used to make a decision regarding chemotherapy treatment. The high level of discordance between the Oncotype DX Recurrence Score and ROR results seen in this study provides additional evidence to support the findings from an independent, previously conducted 1,017-patient comparison study published in the Journal of Clinical Oncology, which showed that Oncotype DX Recurrence Score and ROR classified patients differently (correlation = 0.39) (Dowsett et al, JCO 2013).

“If the question is whether or not to use chemotherapy, Oncotype DX is the only test that has been appropriately studied and validated to answer the specific question of which invasive breast cancer patients need chemotherapy, and all multi-gene tests are not the same,” said Lee S. Schwartzberg, M.D., chief, Division of Hematology Oncology, The University of Tennessee Health Science Center.

This analysis represents the fifth study highlighting the differences between the Oncotype DX breast cancer test and other tests. Previously reported results include presentations at the 2013 ASCO Annual Meeting (Schneider et al), 2012 San Antonio Breast Cancer Symposium (Poulet et al), 13th St. Gallen International Breast Cancer Conference (Poulet et al) and 2011 ASCO Breast Symposium (Dendaluri et al).

Additional Studies Presented at ASCO on Oncotype DX in Breast and Colon Cancer Include:

— An assessment of the prognostic impact of the Oncotype DX test in
node-positive, hormone receptor-positive breast cancer patients treated
with adjuvant chemotherapy and endocrine therapy (Abstract #11052)
— An analysis of biomarker data from the prospective multicenter Phase
II/III WSG-ADAPT trial (Abstract #524)
— An evaluation across healthcare systems showing growing adoption of
Oncotype DX (Abstract #6580)
— A summary of clinical evidence detailing the clinical validation and
utility of the Oncotype DX 12-gene colon cancer test (Abstract #3547)

“The breadth of work being presented at ASCO this year, including studies in breast, colon, prostate and kidney cancer, demonstrates Genomic Health’s increasing commitment to improve cancer care for patients afflicted with these terrible diseases,” said Phil Febbo, M.D., chief medical officer of Genomic Health, Inc. “In the era of precision medicine, it remains critical to demonstrate to physicians that assays provide practice-changing results to inform treatment choice and improve patient care.”

Source: Genomic Health