Genomic Health Announces Five-year Outcomes from International 'PlanB' Study Demonstrating the Clinical Utility of Oncotype DX® in Node-positive and High-risk Node-negative Breast Cancer

One of the Largest Contemporary Adjuvant Breast Cancer Trials in Europe Shows that Patients with Low Oncotype DX® Scores Can Be Spared Chemotherapy Even When Traditional Factors Indicate Higher-Risk Disease.

Genomic Health, Inc. announced new five-year clinical outcomes results from a large PlanB study, which was highlighted as an oral presentation at the 10th European Breast Cancer Conference (EBCC-10)1 in Amsterdam, Netherlands. The study, conducted by the West German Study Group (WSG), showed that 94 percent of early-stage breast cancer patients with Oncotype DX® Recurrence Score® results of 11 or less, who were treated with hormonal therapy alone, were disease-free five years after diagnosis.

These new PlanB study results with five-year outcomes provide information beyond the three-year outcomes published recently in the Journal of Clinical Oncology. The results add to the unprecedented amount of clinical outcomes data on Oncotype DX and are consistent with conclusions of the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, recently published in The New England Journal of Medicine, and results from the Surveillance, Epidemiology, and End Results (SEER) program of the National Cancer Institute (NCI), recently presented at the San Antonio Breast Cancer Symposium.

"Our study shows the unique value of adding biologic information provided by the Oncotype DX test in order to identify low-risk breast cancer patients - among patients with 0-3 involved lymph nodes - who can safely be spared the toxicity and side effects of chemotherapy without compromising outcomes," said Prof. Nadia Harbeck, WSG scientific director and head of the breast center at University of Munich (LMU). "This is especially important for patients who would be considered as intermediate to high risk of recurrence based on traditional clinical parameters. These results confirm previous retrospective studies with Oncotype DX, as well as the prospective TAILORx trial, which already provided results for the node-negative population."

The study, conducted at 93 centers across Germany enrolled more than 3,100 patients with estrogen-receptor positive, HER2-negative, early-stage breast cancer, including those with node-positive disease (up to three nodes) who were considered candidates for chemotherapy by traditional parameters. The Oncotype DX test was used on all patients to identify those who could be spared adjuvant chemotherapy despite being considered as having high clinical risk disease by traditional parameters. Participants with Recurrence Score results of 12 or higher were randomized to different chemotherapy regimens, and patients with Recurrence Score results of 11 or less were treated with hormonal therapy alone.

In women with Recurrence Score results of 11 or less who were treated with hormonal therapy alone, five-year disease free survival (DFS) was estimated as 94 percent. Patients with Recurrence Score results of 12 to 25 who were treated with adjuvant chemotherapy also had high DFS rates of 94 percent, while in patients with Recurrence Score results above 25 who had also received chemotherapy, DFS rates were 84 percent.

Most recently, the German Association of Gynecological Oncology's (AGO's) treatment guidelines distinguished Oncotype DX as the first and only multi-gene breast cancer test with the highest 1A level of evidence, following publication of multiple large prospective outcomes studies. The AGO guidelines also reconfirmed Oncotype DX as the only multi-gene expression test validated to provide predictive information on the likelihood of chemotherapy benefit for women with early-stage, hormone-receptor positive, HER2-negative invasive breast cancer.

"Value in health care depends on results and outcomes, which is vital to the patient. Results from this study clearly show the value benefit of a personalized approach to breast cancer treatment," said Denis Horgan, executive director of the European Alliance for Personalized Medicine. "We hope to see more healthcare systems across Europe provide access to molecular diagnostics that are supported by a high level of scientific evidence and proven clinical utility."