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New Oncotype DX® data further demonstrate the practice-changing impact of the test in guiding the treatment of early stage breast cancer

Genomic Health announced presentation of the first prospective outcomes data from a large adjuvant study with the test at the recent 2014 San Antonio Symposium[1]. 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 .

“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 studies[2,3,4,5] 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 study[6] 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 study[7].

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.”

For more information, please visit, http://www.GenomicHealth.com. To learn more about Oncotype DX, visit: http://www.OncotypeDX.com


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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