GENEVA—Genomic Health recently announced the presentation of 15 abstracts for the Oncotype DX breast cancer test at the 15th St. Gallen International Breast Cancer Conference (SG-BCC) in Vienna, Austria. The Oncotype DX test uses genomic analysis techniques to uncover the unique footprint of each patient’s tumor, and generates a recurrence score result which predicts the likelihood that the patient’s cancer will return and whether chemotherapy is likely to provide benefit.
According to Genomic Health, “The Oncotype DX breast cancer test examines the activity of 21 genes in a patient’s breast tumor tissue to provide personalized information for tailoring treatment based on the biology of their individual disease. The test is intended for use in all newly diagnosed patients with early-stage (stage I, II or IIIa) breast cancer who have node-negative or node-positive (1-3), estrogen receptor-positive (ER+), HER2-negative disease.”
The Oncotype DX tests score between zero and 100. “A low score means the cancer has a lower chance of returning and [the patient has] a lower chance of benefiting from chemotherapy. A high score means the cancer has a higher chance of returning and [the patient has] a higher chance of benefiting from chemotherapy,” Genomic Health explains. “To date, the Breast Recurrence Score test has been ordered in over 500,000 patients.”
The data presented at SG-BCC include a pooled analysis of eight international studies including over 2,500 patients, which assessed the impact of the Oncotype DX test on treatment decisions in routine clinical practice. The results showed the average net reduction in chemotherapy use following testing was 42 percent. Also shown was a detailed budget impact assessment comparing the genomic tests available in Germany. The analysis identified Oncotype DX as the test associated with the highest reduction in chemotherapy use because it appropriately classifies more patients at low risk than other tests, resulting in potential net budget savings of €4,001 per patient tested. And a study from France looked at the test utilization in real-life clinical practice in 827 patients, including those with high-risk disease by traditional parameters. The results demonstrated that the use of Oncotype DX in France reduced the use of chemotherapy by 35 percent.
“The traditional criteria used for making chemotherapy clinical decisions may result in substantial over-treatment and toxicity, with unnecessary costs for healthcare systems. The decision to initiate a course of chemotherapy should be as informed as possible. From a health service perspective it is costly and resource-intensive, but the toll for the patient can be even greater,” said Prof. Joseph Gligorov of the Breast Cancer Expert Center, APHP-Tenon Hospital. “The new evidence presented for the Oncotype DX test highlights the impact it is having across Europe to drive a step-change in the quality of treatment decisions. These results, based on real-world clinical practice, indicate that molecular testing provides clinically meaningful information in addition to classical pathological parameters for a significant proportion of patients and support its broader use and public reimbursement.”
Every year in Europe, over 490,000 new cases of breast cancer are diagnosed. While chemotherapy is routinely offered, research shows that less than 10 percent of patients with early-stage breast cancer actually benefit from it. “Without the Breast Recurrence Score test, doctors can only estimate how likely a patient’s cancer is to return by looking at factors such as age, tumor size, tumor grade and lymph node status,” says Genomic Health. “The Breast Recurrence Score test provides individualized information about [the] tumor that’s not available from these clinical and pathologic features.”
Several posters were presented at the St. Gallen International Breast Cancer Conference, providing further evidence that Oncotype DX accurately predicts outcomes and has important clinical utility in patients whose breast cancer has spread to their lymph nodes. An analysis based on the Surveillance, Epidemiology and End Results registry program of the National Cancer Institute looked at breast cancer-specific survival (BCSS) in more than 6,700 patients. The results showed that five-year BCSS was excellent in patients with recurrence score results less than 18 and micrometastases, 1-3 positive nodes. Survival worsened with increasing number of lymph nodes involved and higher recurrence score results. These findings in node-positive disease were recently updated and published in Breast Cancer Research and Treatment.
A study from Clalit Health Services (Israel) including over 700 patients showed that those with micrometastases and one to three positive nodes with recurrence score results of less than 18, the vast majority (92.9 percent) of whom were treated with hormonal therapy alone, had very good outcomes with low rates of distant recurrence after a median follow-up of 5.9 years.
A review of seven international studies, including more than 9,000 patients with node-positive disease, showed these studies consistently identified patients with a low number of positive nodes (1-3) and low recurrence score results who had good clinical outcomes. And a study from Spain which assessed the impact of the test on treatment decisions in 217 patients found that among the 71 patients with lymph node-positive breast cancer, there was a 72 percent reduction in chemotherapy use. For the group of 146 patients with lymph node-negative disease, the reduction in chemotherapy was 26 percent.
“The momentum for genomic testing is building as healthcare systems across the world recognize its value to patients and society,” commented Dr. Steven Shak, chief scientific officer of Genomic Health. “These latest presentations clearly highlight the impact of Oncotype DX in reducing chemotherapy usage and driving more cost-effective treatment, as well as its value in providing doctors with confidence that their patients will receive the quality care they deserve.”