Genomic Health: New Data Show Important Role of Genomic Testing in Treatment of Older Breast Cancer

Genomic Health announced results from an analysis of patients with hormone-receptor-positive (HR+), early-stage breast cancer at the American Society for Clinical Oncology (ASCO) annual meeting, June 2 – 6, in Chicago, Illinois. New data(1) show that using the Oncotype DX Breast Recurrence Score® test to identify the right patients to treat with chemotherapy, can benefit patients 70 years or greater, similar to the outcomes reported for younger patients.

In the study, from Clalit Health Services, Israel, medical records of 458 elderly, and 2052 younger patients were examined. Using the patients’ Oncotype DX Breast Recurrence Score results, the researchers compared given treatment and subsequent outcomes. The findings showed a similar distribution of Recurrence Score results between the age groups and that within each Recurrence Score result group (low, intermediate and high) there was no statistically significant difference in clinical outcomes between older and younger patients.   

"This research provides insightful data which stresses the importance of addressing and improving the care for elderly patients, including the use of tools that help us predict the likelihood of distant breast cancer recurrence, and the need for chemotherapy," said Prof Salomon Stemmer, Lead Investigator of the study, Department of Oncology, Davidoff Center, Rabin Medical Center affiliated to Tel Aviv University, Israel.

Previously, the European Registration of Cancer Care (EURECCA) study(2), a large-scale international comparison of the treatment of elderly patients with non-metastatic breast cancer, showed that there are substantial differences in outcomes, and the use of surgery, hormone therapy and chemotherapy between European countries. The investigators called for more studies, such as the Clalit study, in order to improve treatment approaches and outcomes in elderly patients with breast cancer.

Real-world evidence confirms Oncotype DX Breast Recurrence Score ability to accurately predict clinical outcomes

Also presented at ASCO was an analysis(3) of the Surveillance, Epidemiology, and End Results (SEER) registry program of the National Cancer Institute (NCI), including over 49,000 patients, which found that in those patients with Recurrence Score results of less than 18, chemotherapy use was uncommon (3-8%) and five-year breast cancer-specific survival (BCSS) rate was high (>99%). In the group with Recurrence Score results of 18-25, chemotherapy was administered more often (29%),and five-year BCSS rate was 99%, regardless of chemotherapy use (in both the chemotherapy-treated and the non-chemotherapy-treated patients).

These data, based on real-world clinical practice, confirm the test’s ability to accurately predict long-term clinical outcomes, highlighting the unique value of Oncotype DX as the only multi-gene breast cancer test with prospective outcome evidence in over 60,000 patients.

"The results presented at ASCO once again reinforce the value of examining tumor biology with Oncotype DX in specific patient populations, such as older women, and add to unprecedented evidence that the Breast Recurrence Score test provides critical information to improve treatment approaches and outcomes in breast cancer patients," said Steven Shak, M.D., Chief Scientific Officer, Genomic Health.     

Additional data demonstrate the value of the Oncotype DX Breast Recurrence Score test in selecting patients for chemotherapy treatment

Results of chemotherapy treatment from the prospective PlanB study(4) were presented at ASCO in an oral session. Findings for the group of HER2-negative, early breast cancer patients with high clinical risk and intermediate-to-high Recurrence Score results, showed a similar five-year disease-free survival for chemotherapy regimens with, and without, an anthracycline, indicating that avoiding an anthracycline may be an important option. In addition, the PlanB Recurrence Score results were consistent with previous chemotherapy trials (NSABP-B28, PACS-01) showing the strong prognostic impact of the Breast Recurrence Score test in chemotherapy-treated patients. Trials evaluating new agents in patients with high Recurrence Score results are warranted.

PlanB, one of the largest contemporary adjuvant breast cancer trials in Europe, is the first prospective study with the Oncotype DX test to report full results. The trial was conducted by the West German Study Group (WSG) and registered more than 3,100 patients who were considered candidates for chemotherapy by traditional parameters including those with node-positive disease (up to three nodes). Previously presented findings from PlanB demonstrated that women with low Recurrence Score results could be effectively treated with hormonal therapy alone, and had five-year disease-free survival of 94%.