MammaPrint Test Accurately Predicts Breast Cancer Recurrence; In First Prospective, Outcome-Based Study of Its Kind
Newswise — IRVINE, CA and AMSTERDAM, THE NETHERLANDS, February 4, 2013 – The MammaPrint breast cancer test can dramatically reduce the number of women who need to undergo chemotherapy to treat the disease, according to a newly published study.
The prospective, outcome-based study of 427 breast cancer patients showed the genomic test, which analyzes 70 key genes, accurately determines which patients are at low risk of breast cancer recurrence and can therefore safely choose not to undergo chemotherapy.
Of the 219 patients in the five-year study who were determined to be “low risk” based on the MammaPrint test, 85 percent chose not to have chemotherapy. Of those patients, 97 percent were disease-free after five years. Of the 208 patients who were determined to be ‘high risk,” 81 percent chose chemotherapy and 91% were disease-free after five years.
“MammaPrint correctly stratified patients into Low Risk and High Risk categories based on prognosis of a recurrence of the disease,” said Prof. S.C. Linn, M.D., the principal investigator. “The outcome data generated in the study confirmed it was safe for the Low Risk patients to choose not to undergo chemotherapy and still have excellent outcomes.”
The results of the peer-reviewed study, called MicroarRAy PrognoSTics in Breast CancER (or RASTER), conducted in 16 community-based clinics in the Netherlands, were published online by The International Journal of Cancer and will later appear in the journal’s print edition.
The RASTER study is considered unique by its co-authors because it is the first and only study to prospectively evaluate the performance of a genomic breast cancer test by using outcome data -- in this case through follow-up of the patient cohort for five years.
“The study showed that incorporating MammaPrint results along with the traditional clinical parameters will significantly reduce the number of women who need chemotherapy, allowing them to avoid the side effects and toxicity of treatment, some of which can be permanent and debilitating,” said breast surgeon Alison Laidley, M.D., FACS with Texas Breast Specialists, Texas Oncology (Dallas).
The study also showed that MammaPrint identified 30 percent more patients as Low Risk than traditional clinical parameters such as; tumor size, grade, patient age and lymph node status, which are often used in the U.S. to determine risk of recurrence. MammaPrint is a 70-gene, breast cancer assay performed on both fresh and FFPE tumor tissue, developed by Agendia.
“Of the prognostic tests commercially available for breast cancer, this is the first and only prospective validation to include outcome data,” said David Macdonald, CEO of Agendia, the company that developed and provides the MammaPrint test. “MammaPrint can be administered to virtually all early-stage breast cancer patients, not just those with certain disease characteristics as with other tests limited to certain receptor and lymph node status. Finally, MammaPrint results benefit the physician by clearly categorizing all patients as high or low risk, eliminating the uncertainty of indeterminate scores reported by other genomic test methods.”
MammaPrint is the first and only FDA-cleared IVDMIA breast cancer recurrence assay. The unique 70-gene signature of MammaPrint provides the unprecedented ability to identify which early-stage breast cancer patients are at risk of distant recurrence following surgery, independent of estrogen-receptor status and any prior treatment. Unlike previous-generation genomic tests, MammaPrint evaluates all of the critical molecular pathways involved in the breast cancer metastatic cascade. It analyzes 70 critical genes that comprise a definitive gene expression signature – more than triple the number of genes analyzed by previous-generation tests -- and stratifies patients into two distinct groups — low risk or high risk of distant recurrence. With MammaPrint, there are no intermediate results.
Agendia is a leading molecular diagnostic company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer Symphony suite was developed using unbiased gene selection, analyzing the complete human genome, ensuring 100% definitive results for cancer patients. Symphony includes MammaPrint, the first and only FDA-cleared IVDMIA breast cancer recurrence assay, as well as BluePrint™¬¬, a molecular subtyping assay, TargetPrint®, an ER/PR/HER2 expression assay, and TheraPrint®, an alternative therapy selection assay. Together, these tests help physicians determine a patient’s individual risk for metastasis, which patients will benefit from chemo, hormonal, or combination therapy, and which patients do not require these treatments and can instead be treated with other less arduous and less costly methods.
In addition to the Symphony suite of tests, Agendia has a rich pipeline of genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology and is a critical partner in the ISPY-2 and MINDACT trials. For more information, please visit www.agendia.com.