REDWOOD CITY, Calif. and PHILADELPHIA, May 2, 2013 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) and the ECOG-ACRIN Cancer Research Group announced today that the Journal of the National Cancer Institute ( JNCI) published positive results from their 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 prospective study, designed and conducted jointly by Genomic Health and ECOG-ACRIN, established that the Oncotype DX DCIS Score goes beyond traditional clinical and pathologic measures to predict the 10-year risk of local recurrence, defined as recurrence of DCIS or invasive breast cancer in the same breast, a finding that will help to guide radiation treatment decision-making for women with DCIS who are treated by local excision. The study was published online today and is scheduled to appear in Volume 105, Issue 10 of the JNCI print edition.
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"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 Lawrence J. Solin, M.D., FACR, FASTRO, principal investigator for this study and chair of the Department of Radiation Oncology at Einstein Medical Center in Philadelphia, Pennsylvania.
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, defined as either the recurrence of DCIS or the development of a new 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.Genomic Health and ECOG-ACRIN researchers analyzed 327 DCIS tumor specimens from patients previously enrolled in the E5194 clinical trial, a prospective study that defined patients at low risk of local recurrence after surgical excision without radiation. E5194 was conducted by the former Eastern Cooperative Oncology Group (ECOG) and sponsored by the National Cancer Institute. The current study validated that the Oncotype DX DCIS Score predicted 10-year local recurrence (DCIS or invasive carcinoma) based on a patient's individualized underlying tumor biology regardless of whether adjuvant tamoxifen was given. At present, tamoxifen use for DCIS is variable in clinical practice.