Genomic Health Test Linked to High Prediction of Recurring Distant Breast Cancer

By Ron Shinkman, Editor, Laboratory Industry Report

A new study in the New England Journal of Medicine has given credence to a molecular assay by California-based Genomic Health as a tool for predicting the risk of distant recurring breast cancer.

After initial treatment, such a form of cancer can metastasize to other parts of the body, such as the lungs or bone marrow. It has been typically associated with an original large tumor, negative hormone receptors or positive HER2 receptors.

However, the study indicates that the use of Genomic Health’s Oncotype DX test, which focuses on 21 genes associated with breast cancer risk, can accurately predict which patients are most likely to suffer a distant recurrence. Patients with low risk scores who undergo hormone therapy alone have about a 1 percent chance of a distant recurrence. Such a prediction allows patients to avoid more grueling regimens of chemotherapy and radiation treatments.

Altogether, more than 10,200 patients were enrolled in the study, which included residents of the U.S. and five other countries. They included more than 1,600 patients who had low risk scores. Low risk scores were also associated with being lymph node-negative, HER2-negative and estrogen receptor positive cancers.

“The compelling results seen in this global study provide unequivocal evidence supporting the clinical utility of Oncotype DX to risk-stratify patients with early stage breast cancer, and indicate that the findings are generalizable to everyday clinical practice,” said lead Joseph A. Sparano, M.D., vice-chairman of medical oncology at Montefiore Einstein Center for Cancer Care, and lead author of the study.

Sparano noted that the risk in these patients of developing a second primary cancer was about three times greater than having a recurrence of the original breast cancer, but chemotherapy would not have prevented such cancers from developing.

Further studies would be conducted to determine the risk of distant recurrence among patients with intermediate risk scores.