Genomic Health, Inc. (Nasdaq: GHDX) announced that Breast Cancer Research and Treatment published results from a second large clinical validation study of Oncotype DX® in patients with stage 0 breast cancer, also known as DCIS (Ductal Carcinoma In Situ). The population-based study, conducted by the Ontario DCIS Study Group, reconfirmed that the Oncotype DX DCIS Score™ is a strong predictor of local recurrence (p < 0.001), which could be either invasive breast cancer or DCIS.
“Our study analyzed the impact of the DCIS Score as an independent predictor of local recurrence in a population cohort of individuals with pure DCIS treated by breast-conserving surgery with clear margins,” said lead investigator Eileen Rakovitch, M.D., FRCP(C), M.Sc., Sunnybrook Research Institute, and the Institute for Clinical Evaluative Sciences, Toronto.
In Canada, it is estimated that DCIS represents up to 25 percent of all breast cancers. Based on a population-based cohort of 828 DCIS tumor samples collected between 1994 and 2003 in Ontario, the primary analysis focused on 571 patients who were treated with breast-conserving surgery alone and had clear margins. The newly published results of the study identified that the majority of studied DCIS patients (62 percent) were low risk based on the tumor biology revealed by the Oncotype DX DCIS Score. The remaining cases had an intermediate-risk or high-risk score, and these patients experienced a higher risk of local recurrence.
“We see a genomic test like Oncotype DX as an exciting advance in precision medicine and customization of healthcare, which is particularly important to the young women we serve who are diagnosed with DCIS and face decisions about treatments that can impact fertility and cause long-term side-effects,” said MJ DeCoteau, executive director at Rethink Breast Cancer. “While the majority of DCIS is not life threatening, it is important for patients to rely on a scientifically validated tool to get precise biological information about their tumor to add confidence in one’s treatment choice.”
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