Study shows Genomic's Oncotype breast cancer test changed treatment decisions for patients

By E. Janene Geiss

Philadelphia, Dec. 9 - Genomic Health, Inc. announced Friday results of a community-based, investigator-sponsored study that demonstrated its Oncotype DX 21-gene panel breast cancer test, which quantifies the likelihood of recurrence and predicts chemotherapy benefit for a large portion of early stage breast cancer patients, changed treatment decisions for patients.

The study evaluated the experience of four oncologists treating 68 early stage, estrogen-receptor-positive breast cancer patients and found that knowledge of the Oncotype DX Recurrence Score, a score between 0-100 assigned based on a quantitative measurement of the expression of 21 genes, altered the adjuvant treatment administered to 25% of patients compared to physicians' original recommendations, according to a company news release.

"Our findings clearly indicate that assessing a woman's individual Recurrence Score in addition to standard measures, such as patient age, tumor size and tumor grade, is critical to making well-informed treatment decisions," said Ruth Oratz, clinical associate professor, NYU School of Medicine and lead author of the study, in the release.

She and her colleagues conducted the study when she was at Rocky Mountain Cancer Center.

"We were impressed to see just how often this commercially available and clinically validated test changed the course of treatment. Oncotype DX provides my patients with valuable information about their individual cancer and greater confidence in their treatment selection," she said.

Treatment recommendations by physicians changed for 14 of the 68 patients in this study. Specifically, seven changed from chemotherapy in combination with hormone therapy to hormone therapy alone and seven changed from hormone therapy alone to chemotherapy in combination with hormone therapy.

The decision to switch from chemotherapy and hormone therapy to hormone therapy alone was associated with low Recurrence Scores, while the decision to switch from hormone therapy to chemotherapy in combination with hormone therapy was associated with high Recurrence Scores, officials said.

These results were presented Friday at the 28th Annual San Antonio Breast Cancer Symposium in San Antonio.

Genomic said Oncotype DX is the first diagnostic multi-gene expression test commercially available that has clinical evidence validating its ability to predict the likelihood of breast cancer recurrence, the likelihood of patient survival within 10 years of diagnosis and the likelihood of chemotherapy benefit.

The test has been extensively evaluated in multiple independent studies involving more than 2,600 breast cancer patients, including a large validation study published in The New England Journal of Medicine.

Genomic is a Redwood City, Calif., life science company focused on the development and commercialization of genomic-based clinical diagnostic tests for cancer that allow physicians and patients to make individualized treatment decisions.

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