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Genomic Health Announces Presentation Of Oncotype DX® Studies Reinforcing Value Of Tests In Guiding Treatment For Multiple Cancers

Stocks in this article: GHDX

AMSTERDAM and REDWOOD CITY, Calif., Oct. 1, 2013 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today announced results from four studies highlighting the value of its Oncotype DX ® tests for optimizing treatment for patients with breast and colon cancer.  Three new decision impact studies - including the company's first international decision impact study in colon cancer and additional evidence for the Oncotype DX breast cancer test's significant impact on breast cancer treatment decisions in the United Kingdom (UK) - were among data presented at the European Cancer Congress 2013, taking place September 27-October 1 in Amsterdam.  The results were presented on the heels of the recent National Institute for Health and Care Excellence (NICE) guidance announcement that recommended the use of Oncotype DX "as an option to help clinicians decide whether to prescribe chemotherapy in people with early breast cancer."     


"By continuing to invest in research and clinical utility studies, we are able to provide actionable genomic information to facilitate more informed cancer treatment decisions," said Christer Svedman, director, medical affairs in Europe, Genomic Health.  "The growing body of evidence and the consistency of results for both the invasive breast and colon cancer tests clearly establish them as valuable tools for patients and physicians worldwide."

Further Evidence Confirms Oncotype DX Results Significantly Impacts Breast and Colon Cancer Treatment Decisions

  • A prospective multi-center study of 148 early-stage, estrogen receptor-positive breast patients from the United Kingdom confirmed that use of the Oncotype DX breast cancer test was associated with a significant change in treatment decisions and an overall 23 percent net reduction in chemotherapy use.  Findings from this second decision impact study in the UK are consistent with those previously reported from the UK and 17 other Oncotype DX decision impact studies from Europe, Australia, Japan, Mexico and North America.  The results underscore the value of using the test in the UK where NICE recently recommended Oncotype DX. Further, updated St. Gallen International guidelines have, for the second time, recognized the Onco type DX breast cancer test as the only multi-gene test to predict chemotherapy benefit in patients with early-stage endocrine sensitive invasive breast cancer. (Abstract 2068: "A prospective multi-centre study of the impact of Oncotype DX on adjuvant treatment decisions in patients in the UK with estrogen receptor positive early breast cancer," Sept. 30, 14:00-16:30 CEST, Hall 4)

"Utilizing genomic medicine to optimize cancer treatment is becoming an increasingly important focus for physicians worldwide," said Jeremy Braybrooke, M.D., University Hospitals Bristol in the United Kingdom. "With the recent NICE recommendation and continued research demonstrating Oncotype DX's clinical relevance in early-stage breast cancer, we can use this test to help more UK patients benefit from individualized treatment."

The results of two colon cancer studies from Israel and the Unites States highlight the value of individualized recurrence risk assessment to enable physicians to identify high-risk patients who can experience a greater potential benefit from chemotherapy, as well as patients with a low risk of recurrence who can be spared unnecessary treatment.

  • A prospective study of 269 colon cancer patients with stage IIa, mismatch-repair proficient (MMR-P) disease in Israel showed that the Oncotype DX colon cancer test changed treatment decisions in 38 percent of patients.  For patients whose treatment recommendations changed, treatment intensity decreased for 28 percent of patients (from chemotherapy to observation or from oxaliplatin-containing to non-oxaliplatin containing regimens) and increased for 10 percent of patients (from observation to any chemotherapy or from non-oxaliplatin containing to oxaliplatin-containing treatment).  (Abstract 2382: "Impact of the 12-gene colon cancer recurrence score assay on clinical decision-making for adjuvant therapy in stage II colon cancer patients in Israel," Sept. 29, 14:00-16:30 CEST, Hall 4)
  • This study, conducted in collaboration with the Mayo Clinic Cancer Research Consortium, analyzed treatment decisions for 141 colon cancer patients with stage IIa, MMR-P disease across 17 sites demonstrating that the use of the Oncotype DX colon cancer test changed treatment decisions 45 percent of the time and led to an overall reduction in chemotherapy use. For patients whose treatment recommendations changed, treatment intensity decreased for 33 percent of patients (from chemotherapy to observation or from oxaliplatin-containing to non-oxaliplatin containing regimens) and increased for 11 percent of patients (from observation to any chemotherapy or from non-oxaliplatin containing to oxaliplatin-containing treatment).  The decrease in physician recommendations for adjuvant chemotherapy resulted in direct medical care costs savings of $1,683 per patient. (Abstract 2184: "Prospective multi-center study of the impact of Oncotype DX Colon Cancer Assay results on treatment recommendations in stage II colon cancer patients," Sept. 30, 11:30- 12:30 CEST, RAI Auditorium)

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