Clinical outcome results published from large Oncotype DX study

March 1, 2016 – REDWOOD CITY. Genomic Health, Inc. announced that the Journal of Clinical Oncology published clinical outcomes results from PlanB, one of Europe’s largest adjuvant studies that utilized the Oncotype DX® breast cancer test to assign treatment. Led by the West German Study Group (WSG) in Germany, results from the PlanB study showed that women with Oncotype DX Recurrence Score® results of 11 or less had excellent outcomes with 98 percent disease-free survival rates at three years, despite having high-risk disease by traditional parameters. This finding is consistent with conclusions of the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, recently published in The New England Journal of Medicine, adding to the unprecedented body of evidence demonstrating that Oncotype DX accurately predicts outcomes, including breast cancer recurrence and survival, in data collected from more than 50,000 patients.

“The compelling suite of new global prospective outcomes data generated in the last six months proves that tens of thousands of patients worldwide can forgo chemotherapy and its harmful side effects based on a low Recurrence Score,” said Steven Shak, M.D., chief scientific officer, Genomic Health. “Not only do these collective results support our prior validation work and all of the guidelines worldwide that include Oncotype DX to select patients for chemotherapy treatment, they also provide physicians with the highest level of evidence to support using the test as standard of care.”

This large study, conducted in 93 centers across Germany, enrolled more than 3,100 patients with high-risk, estrogen-receptor positive, HER2-negative early-stage breast cancer, including those with node-positive disease who were considered candidates for chemotherapy by traditional parameters. Oncotype DX Recurrence Score results were used to identify patients who would be spared adjuvant chemotherapy despite being considered as having high clinical risk 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.

The study showed that women with Recurrence Score results of 11 or less had excellent outcomes at three years despite having high-risk disease by traditional parameters, such as nodal status. The results indicate that chemotherapy can safely be spared in patients with high clinical risk of recurrence – including node-positive disease – if the Recurrence Score result is 11 or less.

“Our study results show that a low Recurrence Score result identifies patients who can be safely spared chemotherapy without compromising outcomes. These results confirm previous retrospective studies as well as the prospective TAILORx trial,” said Prof. Nadia Harbeck, WSG Scientific Director and Head of the breast cancer unit at University of Munich, Germany.

Findings from the PlanB study also suggest there may be overtreatment in a substantial subset of patients who have Recurrence Score results between 12 and 25, as patients in this range also had excellent outcomes with disease-free survival of 98 percent at three years. These findings add to a recent study from Clalit Health Services, the largest Health Maintenance Organization in Israel, that showed that women with Recurrence Score results of less than 18 who were largely treated with hormonal therapy alone had excellent outcomes with less than a one percent chance of distant recurrence or breast cancer-specific mortality at five years.

“Patients should only get chemotherapy with all its side effects if they are going to benefit substantially. Gene expression tests often play an important role in making this decision,” said Renate Haidinger, president of the German Breast Cancer Association, the leading national patient advocacy organization in Germany. “Based on the latest study results, we hope that patients can get broad access to this test.”

Five-year results from PlanB will be highlighted in the official European Breast Cancer Conference (EBCC-10) press program on Thursday, March 10, followed by the oral presentation on Friday, March 11, at a plenary session.

SOURCE Genomic Health, Inc.

http://jco.ascopubs.org/content/early/2016/02/24/JCO.2015.63.5383.abstract

http://www.nejm.org/doi/full/10.1056/NEJMoa1510764?af=R&