- First prospective outcomes data reinforce the Oncotype DX test’s unique value in informing treatment decisions
- Positive results of second large, independent validation study in DCIS breast cancer
GENEVA, Switzerland, [December 15, 2014] – Genomic Health announced presentation of the first prospective outcomes data from a large adjuvant study with the Oncotype DX breast cancer test at the recent 2014 San Antonio Breast Cancer Symposium1. Early results from the Plan B study support the use of the Oncotype DX breast cancer test to optimise treatment recommendations based on individual patient risk.
The study, conducted by the Women’s Healthcare Study Group (WSG) in more than 90 centres across Germany, is one of Europe’s largest contemporary adjuvant breast cancer trials and used the Oncotype DX Recurrence Score® results to identify patients who would be more likely to benefit from chemotherapy treatment.
“Our study results show that a low Recurrence Score identifies patients who can be safely spared chemotherapy without compromising outcomes. These results confirm prospectively conducted earlier trials,” said Prof. Ulrike Nitz, lead investigator of the study, head of the breast cancer/senology unit at the Bethesda Hospital, Monchengladbach, Germany.
In this analysis of 3,198 patients, mostly classified as candidates for chemotherapy by traditional parameters, participants with Recurrence Score results of 12 or higher were randomised to different chemotherapy regimens. At three years follow-up, patients with Recurrence Score results of 11or less who received only endocrine therapy had high event free survival rates (98.3 percent) despite having high risk disease by traditional parameters. The low risk of recurrence for patients with low scores is consistent with previously presented validation studies2,3,4,5 for the Oncotype DX test.
Researchers will continue to follow patients and report results and outcomes.
Positive results of largest genomic study in DCIS reconfirm Oncotype DX is a strong, independent predictor of local recurrence
Genomic Health also announced positive results from the second large clinical validation study6 of Oncotype DX in patients with a pre-invasive form of breast cancer known as DCIS (ductal carcinoma in situ). The study, conducted by the Ontario DCIS Study Group of Sunnybrook Health Sciences Centre in Canada, showed that the Oncotype DX DCIS Score™ result is a strong predictor of local recurrence, which could be either invasive breast cancer or DCIS (p=<0.001). These results confirm and extend the conclusions of the previously published validation study7.
In Europe, as many as 50,000 women may be diagnosed with DCIS (stage 0 breast cancer) every year. After a diagnosis of DCIS, the first step is usually breast-conserving surgery to remove the DCIS tumour. In addition, the vast majority of women with DCIS will receive radiation therapy; some will also have five years of endocrine therapy because currently used markers cannot identify a group of patients with a sufficiently low risk of recurrence to withhold therapy.
The Oncotype DX DCIS Score result provides more precise information about the individual risk of a recurrence of either DCIS or invasive breast cancer by looking at 12 genes within a tumour sample to reveal the aggressiveness of the disease – a key factor in deciding treatment after surgery.
“The data from Plan B continue to highlight the ability of the Oncotype DX test to stratify patient risk and importantly also provide the first robust prospective data”, said Christer Svedman, M.D., Director of Medical Affairs Europe at Genomic Health. “In addition, the new DCIS data reinforce the important role of genomic testing to help make more informed treatment decisions in patients with this pre-invasive form of the disease.”
About Genomic Health
Genomic Health, Inc. is a world-leading provider of genomic-based diagnostic tests that inform treatment decisions and help to ensure each patient receives appropriate treatment for early stage cancer. The company is applying its state-of-the-art scientific and commercial expertise and infrastructure to translate significant amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient’s journey; from screening and surveillance, through diagnosis and treatment selection. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com. To learn more about Oncotype DX, visit: www.OncotypeDX.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 attributes and focus of the company’s product pipeline; the applicability of clinical study results to actual outcomes; the ability of any potential tests the company may develop to optimize cancer treatment; and the ability of the company to develop and commercialize additional tests in the future. 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 uncertainties associated with the regulation of the company’s tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests and expand into new markets domestically and internationally; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; the company’s ability to obtain capital when needed 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, 2014. 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.
1. Nitz U et al. Abstract: P4-11-01; SABCS 2014
2. Paik S et al. NEJM 2004;351:2817-26
3. Habel LA et al. Breast Cancer Res 2006;8:R25
4. Toi M et al. Cancer 2010;116:3112-8
5. Dowsett M et al. J Clin Oncol 2010;28:1829-34
6. Rakovitch E et al. Abstract: S5-04; SABCS 2014
7. Solin LJ et al. J Natl Cancer Inst. 2013; May 15;105(10):701-10
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