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The Journal of the National Cancer Institute (JNCI) has published positive results from the clinical validation study of the Oncotype DX® DCIS Score in patients with ductal carcinoma in situ (DCIS), an early or pre-invasive form of breast cancer. The study, led by principal investigator, Lawrence J. Solin, MD, FACR, FASTRO, Chair of the Department of Radiation Oncology at Einstein Medical Center Philadelphia, was conducted jointly by Genomic Health and ECOG-ACRIN, and established that the Oncotype DX® DCIS Score goes beyond traditional clinical and pathologic factors to predict the 10-year risk of local recurrence, defined as recurrence of DCIS or invasive breast cancer in the same breast. The study findings will help to guide individualized decision making in women with DCIS who are treated by surgical excision. The detection of DCIS is increasing in the United States, with more than 50,000 patients diagnosed each year. Most women with DCIS who receive breast-conserving surgery without standard radiotherapy will not develop a local recurrence of DCIS or an invasive cancer in the same breast. Unfortunately, traditional clinical and pathologic criteria are insufficient to define a low-risk population for whom excision alone may be adequate. "The management of DCIS has been variable in the absence of reliable methods to select patients for treatment with surgical excision alone, without radiation. The DCIS Score is a new tool that can help physicians and patients make more informed decisions,” said Dr. Solin.Genomic Health and ECOG-ACRIN researchers analyzed 327 DCIS tumor specimens from patients previously enrolled in the E5194 study, a prospective study that attempted to identify patients at low risk after surgical excision without radiation. Conducted by the former Eastern Cooperative Oncology Group (ECOG), E5194 was performed under the sponsorship of the National Cancer Institute. This study validated that the Oncotype DX® DCIS Score predicted the 10-year risk of local recurrence (DCIS or invasive carcinoma) based on a patient's individualized underlying tumor biology and regardless of whether adjuvant tamoxifen was given. The study demonstrated that 70 percent of patients who met the eligibility criteria for participation in ECOG E5194 had a low DCIS Score, and that such patients may be eligible for treatment using surgical excision without radiation treatment. Compared to patients whose tumor had an intermediate or high DCIS Score, patients with a low DCIS Score had a significantly lower likelihood of a local recurrence at 10 years (about 11 percent vs. 26 percent, respectively). In addition, a low DCIS Score was associated with a significantly lower risk of developing a subsequent invasive breast cancer. The DCIS Score was predictive of local recurrence across patient subgroups regardless of lesion size, grade, surgical margins, or menopausal status.The results from this study are a major step forward in our ability to individualize and tailor local treatment options for the woman with newly diagnosed DCIS of the breast. The DCIS Score allows physicians to assess the individual patient’s risk and to personalize treatment after surgical excision for DCIS," said Dr. Solin.