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Genomic Health Announces Presentation of Oncotype DX Studies Reinforcing Value of Tests in Guiding Treatment for Multiple Cancers

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Genomic Health, Inc. (Nasdaq: GHDX) recently 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 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 Oncotype 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)

New Data Suggest There is Similar Underlying Biology in Colon and Rectal Cancer

As part of the company’s commitment to studying the use of Oncotype DX in different types and stages of cancer, researchers also reported results from a clinical validation study of the colon cancer test in stage II and stage III rectal cancer patients treated with surgery alone, which demonstrated similarities in colon and rectal cancer biology.

  • The study, conducted by the Department of Surgery at the Leiden University Medical Centre, evaluated the Recurrence Score® results and recurrence risk in rectal cancer patients from the landmark Dutch Total Mesorectal Excision (TME) trial. All 297 patients analyzed from the trial had stage II or III rectal cancer and were treated with surgery alone. In this population of rectal cancer patients, the Recurrence Score predicted recurrence risk (p=0.011), with particularly strong results in stage II. The test was also shown to predict the risk of distant recurrence and rectal cancer specific survival (p=0.030 and p=0.007 respectively). These results suggest that the Oncotype DX colon cancer test may help identify high-risk rectal cancer patients who could benefit from and low-risk patients who may forego aggressive therapies. (Abstract: Validation of the 12-gene colon cancer Recurrence Score assay as a predictor of recurrence risk in stage II and III rectal cancer patients,” Sept. 28, 13:45-15:55 CEST, Hall 7.1)

In addition to the data presentations during the European Cancer Congress 2013, Genomic Health also led a satellite symposium titled, “A View to Next Generation Sequencing in Cancer.” Samuel Levy, Ph.D., chief scientific officer at Genomic Health, joined a panel discussion with leading international genomics and oncology experts to discuss the impact of next generation sequencing (NGS) on current and future cancer care from medical, scientific and health-economic perspectives. Levy is the senior author of the first published diploid genome sequence of a human, and had a distinguished career in genomics prior to joining Genomic Health, including his tenure at Scripps and the J. Craig Venter Institute.

“In harnessing the power of NGS technology, our scientists can analyze a wealth of genomic data to discover how cancer genomes are able to modify gene expression via mutation strategies,” said Levy. “As a leader in cancer genomics, our goal with the symposium was to continue the international dialogue on the promise of how sequence-based genomics will enable ‘big data’ to impact future clinical development in cancer.”

Source: Genomic Health