New Node-Positive Breast Cancer Utility Data

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Oncotype DX Accurately Predicts Clinical Outcomes in Patients with Node-Positive Breast Cancer

At the most recent 2016 European Society for Medical Oncology (ESMO) Congress, results were shared from two studies involving the SEER (Surveillance, Epidemiology and End Results) program of the National Cancer Institute (NCI) and the Clalit Health Services, the largest health care services provider in Israel, showing the clinical utility of Oncotype DX in predicting breast cancer outcomes in patients with early-stage, node-positive disease.

The SEER study, recently published in Nature Partner Journals Breast Cancer, demonstrated that the Oncotype DX® Breast Recurrence Score™ (RS) test accurately predicted prospective patient outcomes, including over 6,700 patients with 1 to 3 node-positive breast cancer.

The SEER results presented at ESMO include additional data and follow-up for patients, linking the Registry data of breast cancer cases from 2004 to 2013 to Oncotype DX RS results. In the 3,919 node-positive patients with an RS less than 18, five-year breast cancer-specific survival was excellent with a survival rate of over 97 percent in patients with micrometastases and one and two positive nodes.

Additionally, results from the Clalit retrospective study examined the records of more than 700 patients tested with Oncotype DX. A vast majority (92.9 percent) of patients with a RS less than 18 with either micrometastases or one to three positive lymph nodes who were treated with hormonal therapy alone had very good outcomes. They had a low rate of distant recurrence (3.2 percent) and excellent breast cancer survival (> 99 percent) at five years.

“Just as we have learned in node-negative disease, it is now increasingly evident that women with one to three positive nodes and lower scores do extremely well without chemotherapy,” said Kathy S. Albain, MD, FACP, FASCO, Professor of Medicine, Loyola University Chicago, Cardinal Bernardin Cancer Center, Maywood, Illinois. “These data, along with previously published results, provide extremely strong evidence to justify use of Oncotype DX in 1-3 node-positive disease. If the patient’s tumor biology is that of a low Recurrence Score, chemotherapy simply does not add benefit, and its risks and costs can be avoided.”

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