Medical Device Daily Staff Writer

Personalizing the care of cancer patients is a key part of healthcare reform cost-cutting efforts. That's the message from Genomic Health (Redwood City, California), which has just published its first study to show that Oncotype DX breast cancer test simultaneously impacted breast treatment decisions by both patients and physicians.

"Reducing healthcare costs is about using diagnostic tests to better identify the right drug for the right patient," Steven Shak, MD, chief medical officer of Genomic Health, told Medical Device Daily. "At the time of diagnosis, one naturally asks Will it come back and what's the right treatment for me?' This is particularly challenging for women with early breast cancer."

The Oncotype DX test is a multigene expression test already commercially available that predicts the likelihood of chemotherapy benefit as well as recurrence in early stage breast cancer. The test has been previously evaluated in 13 studies. More than 8,000 physicians have used it for more than 120,000 breast cancer patients. This latest study, published in the Journal of Clinical Oncology, found that knowledge of a patient's Recurrence Score changed oncologists' treatment recommendations in 31.5% of cases and changed 27% of breast cancer patients' treatment decisions.

"The goal of the study was to prospectively evaluate, from both the physician and patient perspectives, if use of the assay changes treatment recommendations," Shak said. "The second goal was to evaluate, as we bring new genomic technologies to practice, what the patients' response is to Oncotype DX. Are they satisfied? Do they understand the results? These results showed that the assay treatment decisions changed one-third of a time. Patients understood the assay and its use. There was a very high degree of satisfaction. From a physician's perspective, not only did the assay increase or change treatment choices one-third of the time, but it also led them to be more confident of the decisions."

The study evaluated 89 breast cancer patients treated by 17 medical oncologists from three academic centers and one community practice. The most common change in treatment plan occurred among breast cancer patients who received a low Recurrence Score result – switching from an initial pre-Recurrence Score plan of chemotherapy plus hormonal therapy, to a treatment plan of hormonal therapy alone.

"There are additional factors in a tumor that drive its biologic behavior that we cannot identify from a good pathology report alone," said Kathy Albain, MD, professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Loyola University Chicago Stritch School of Medicine, and senior author of the study. "By knowing the Oncotype DX Recurrence Score, we can often avoid giving chemotherapy to patients we previously thought needed it, while offering chemotherapy with confidence to those for whom there was no indication for it based on traditional pathologic measures."

Shak pointed out that how the test is actually used in clinical practice and what it does to the cost of healthcare also is an important aspect of the findings.

"A key topic in this era of healthcare reform is what we can do to provide better healthcare," he said. "What has been already been published is that the assay is cost effective. More women go from chemotherapy to hormonal therapy based on these scores than in the other direction. We are just beginning to see presentation of data that shows the favorable impact on healthcare costs. In terms of the big picture, to me it means the approach of genomic health, to personalize cancer care, is going to be a key part of what we need to do in healthcare reform."

Shak predicts that there's going to be a growing emphasis on the importance of diagnostics like Oncotype DX. "Often devices and diagnostics receive less attention than drugs," he said. "But the role that diagnostics currently play is enormous. More than 80% of decisions are guided by diagnostic test. I see a future where all drugs should be considered as targets for these kinds of tests."

Genomic Health is following that vision, working to develop similar genomic tests for colon, prostate and renal cancers. Shak said the colon cancer test would likely be available within a few months.

The company also is working make sure all patients have access to the breast cancer test, which costs $3910 and is reimbursed by all major payers and Medicare. For those patients who are uninsured or underinsured, the company foots the bill through a special program.

Lynn Yoffee; 770-361-4789

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