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Genomic Health Presents New Data Demonstrating Value of Oncotype DX® to Optimize Breast Cancer Outcomes and Reduce Treatment Burden throughout Disease Continuum
"Over the past 14 years, we have collaborated with clinical and academic thought leaders to present data at SABCS that has transformed breast cancer care. As this world-leading breast cancer conference marks its 40th anniversary, we are proud to contribute important new information that supports the use of Oncotype DX in both the adjuvant and neoadjuvant settings," said
Validation Shows Oncotype DX Breast Recurrence Score Test Predicts Clinical Response to Neoadjuvant Hormonal Therapy to Improve Surgical Outcomes
Neoadjuvant systemic therapy prior to surgery, such as chemotherapy and/or hormonal therapy, can shrink tumor size and allow breast conserving surgery (BCS) in patients who may otherwise receive a full mastectomy. However, chemotherapy can be toxic and, in some patients, does not provide improved surgical outcomes over hormonal therapy. Core needle biopsy samples from 294 postmenopausal patients enrolled in the Phase 3 NEOS neoadjuvant (treatment before surgery) study of estrogen-receptor positive breast cancer and tumor size ≥2 centimeters were analyzed to determine clinical response to neoadjuvant hormonal therapy. The analysis demonstrated that Recurrence Score® (RS) results significantly predicted the likelihood of clinical response to neoadjuvant therapy (p < 0.001). Specifically, the findings suggest that, for patients with a RS result below 18, treatment with neoadjuvant hormonal therapy alone could be an effective treatment strategy, resulting in BCS in 79 percent of cases.
"This important clinical validation study demonstrates that analyzing tumor biology with Oncotype DX in the neoadjuvant setting can help guide important treatment decisions," said Prof.
Many Node-positive Breast Cancer Patients Can Avoid Chemotherapy Based on Recurrence Score Result
Consistent with previously published findings, an analysis from the
SEER Registry Analysis Supports New AJCC Staging Criteria, Confirming Many Patients with Poor Prognostic Factors May Be Downstaged to Stage 1A Disease Based on Their Oncotype DX Breast Recurrence Score Result
"Genomic testing has transformed the way we treat early-stage invasive breast cancer, and there is now unequivocal evidence demonstrating that Oncotype DX can consistently and accurately predict chemotherapy benefit and the risk of distant recurrence across patient populations, including those with node-positive disease," said
Additional Oncotype DX Presentations Reinforce Unmatched Value of Tests in Multiple Patient Populations
- Prospective 10-year, long-term clinical outcomes from a registry of more than 1,500 patients tested with Oncotype DX within
Clalit Health Services, the largest health maintenance organization in Israel, demonstrated that patients with low RS results treated with hormonal therapy alone showed low 10-year distant recurrence rates. Specifically, the findings showed that use of chemotherapy was aligned with RS results, and that node-negative patients with RS results less than 18 -- the vast majority (98.2 percent) of whom were treated with hormonal therapy alone -- had excellent outcomes, with a 10-year distant recurrence risk of 4 percent.
- A new analysis revealed distinctive biological features for breast cancer in men compared with women, and confirmed that genomic profiling with Oncotype DX testing also provides clinical value for guiding treatment decisions in men regardless of nodal status.
- New data from the prospective
West German Study Group's(WSG) PlanB study, one of the largest contemporary adjuvant breast cancer trials in Europe, reinforce the value of utilizing the Oncotype DX Breast Recurrence Score test to evaluate tumor biology in older women. The results demonstrated that patients age 70 or older, whose performance status allows them to be candidates for chemotherapy and have high Recurrence Score results, do as well as younger patients. The researchers suggest that elderly patients should receive genomic testing to determine their breast cancer risk and, if they are determined to be high risk, should receive chemotherapy to optimize outcomes.
- Two new analyses evaluating the results from women with ductal carcinoma in situ (DCIS) confirmed the ability of the Oncotype DX DCIS Score test to provide estimates of recurrence risk.
About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. The company's flagship product, the Oncotype DX Breast Recurrence Score® test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer. Additionally, the Oncotype DX Breast DCIS Score™ test predicts the likelihood of recurrence in a pre-invasive form of breast cancer called DCIS. In prostate cancer, the Oncotype DX Genomic Prostate Score™ test predicts disease aggressiveness and further clarifies the current and future risk of the cancer prior to treatment intervention. With more than 800,000 patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit www.OncotypeIQ.com, www.MyBreastCancerTreatment.org or www.MyProstateCancerTreatment.org.
About Genomic Health
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the results of clinical studies; the impact of clinical studies on reimbursement and test adoption; the applicability of clinical study results to actual outcomes; the commercial performance of the company's tests; and the benefits of the test to physicians, patients and payors. 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 risk that the company may not obtain or maintain adequate levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the ability of the company to achieve expanded coverage of reimbursement for its existing tests and the ability of any such expanded coverage to result in additional revenue; the ability of test results to change treatment decisions; the risks of competition; the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes and the ability to demonstrate sufficient clinical utility; unanticipated costs or delays in research and development efforts; and the other risks set forth in the company's filings with the
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