Genomic Health Announces Results of Clinical Survey Showing Use of Oncotype DX(R) Changes Treatment Recommendations for Women With Lymph Node-Positive Breast Cancer, Leading to Overall Reduction in Chemotherapy
SAN ANTONIO, Dec. 11 /PRNewswire-FirstCall/ — Genomic Health, Inc. (Nasdaq: GHDX) today announced results from a clinical survey evaluating the impact of the Oncotype DXÃ‚® Recurrence ScoreÃ‚® result on physicians’ adjuvant treatment recommendations for patients with node-positive, hormone receptor-positive breast cancer. The findings, presented as a poster at the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium (Abstract # 2031), demonstrated that physicians frequently changed treatment recommendations for breast cancer patients with 1-3 positive nodes after integrating Recurrence Score results.
Oncotype DX is a multi-gene expression test that physicians currently use to predict the likelihood of chemotherapy benefit and recurrence risk for patients with early-stage breast cancer. This survey of 160 medical oncologists about their clinical experience with Oncotype DX in node-positive breast cancer was conducted through a voluntary web-based questionnaire, and found that treatment recommendations changed for half of the patients after obtaining a Recurrence Score result.
Specifically, in the 138 cases where the physician had a specific treatment recommendation before obtaining the Recurrence Score, recommended treatment changed from hormonal therapy plus chemotherapy to hormonal therapy alone in 46 patients (33 percent), and from hormonal therapy alone to hormonal therapy plus chemotherapy in 13 patients (9 percent). Other regimen changes such as treatment intensity were reported in 11 patients (8 percent). In these patients with node-positive disease, 72 (52 percent) of patients analyzed had a low Recurrence Score result (<18), 53 (38 percent) had an intermediate Recurrence Score result (18-30) and 13 (9 percent) had a high Recurrence Score result (greater than or equal to 31). Recommendations based on the Recurrence Score results led to an overall reduction in chemotherapy.
“The clinical experiences of these physicians underscore the value of using Oncotype DX for node-positive breast cancer patients as demonstrated in five previous studies including one published yesterday in the online version of The Lancet Oncology,” said Ruth Oratz, M.D., Clinical Associate Professor of Medicine, New York University School of Medicine, and lead author of the study. “As someone who has used Oncotype DX for treatment planning with both node-negative and node-positive breast cancer patients, I believe this test is becoming standard practice for individualizing treatment in early stage breast cancer.”
In this survey of 160 patients with node-positive disease, median age was 61 years and 79 percent of patients were postmenopausal. Patients had either stage T1 (62 percent), T2 (35 percent) or T3 (3 percent) disease. One, two, three or four or more positive lymph nodes were reported in 69 percent, 18 percent, 6 percent and 3 percent of patients, respectively. Therefore, physicians reported use of the Oncotype DX Recurrence ScoreÃ‚® result to plan treatment for node-positive disease most often in patients with 1-3 positive nodes and stage T1 or T2 disease.
“Results from this survey of current practice patterns indicate that oncologists who order Oncotype DX for patients with node-positive breast cancer use the results in a similar manner as they do for node-negative patients,” said Steven Shak, M.D., Chief Medical Officer of Genomic Health.
About Oncotype DXÃ‚®
The Oncotype DX breast cancer test is the only multigene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. Additionally, the test report provides quantitative scores for certain individual genes. The Oncotype DX breast cancer test has been extensively evaluated in thirteen clinical studies involving more than 4,000 breast cancer patients worldwide, including a large validation study published in The New England Journal of Medicine and a chemotherapy benefit study published in the Journal of Clinical Oncology. As of November 2009, more than 8,000 physicians have ordered more than 120,000 tests in over 50 countries, and both Medicare and private health plans covering over 90 percent of U.S. insured lives, provide reimbursement for Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive through contracts, agreements or policy decisions. Both the American Society of Clinical Oncology and the National Comprehensive Cancer Network recommend the use of Oncotype DX for patients with node-negative breast cancer that is estrogen-receptor positive and/or progesterone-receptor positive. For more information about Oncotype DX, please visit www.oncotypedx.com.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is a life science company focused on the development and commercialization of genomic-based clinical laboratory services for cancer that allow physicians and patients to make individualized treatment decisions. In 2004, Genomic Health launched the Oncotype DXÃ‚® breast cancer test, which has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in early-stage breast cancer. In addition to the widely adopted Oncotype DX breast cancer test, Genomic Health is preparing to launch its Oncotype DX colon cancer test in the first quarter of 2010. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit www.genomichealth.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the belief that the clinical experiences of physicians surveyed underscores the value of using Oncotype DX for node-positive breast cancer patients, the belief Oncotype DX is becoming standard practice for individualizing treatment in early stage breast cancer, the ability of the Oncotype DX breast cancer test to change clinical outcomes, the company’s plans to commercialize a test for colon cancer and the proposed timing of such commercialization, and the applicability of clinical study results to actual outcomes . Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the risks and potential delays associated with commercialization of a new test; the risks and uncertainties associated with the regulation of the company’s tests; the applicability of clinical study results to actual outcomes; the availability of reimbursement coverage for the company’s test in specific disease populations; and the other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2009. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
SOURCE Genomic Health