Agendia has announced that five-year follow-up data from the RASTER observational study indicates that its MammaPrint prognostic assay for breast cancer can help reduce adjuvant chemotherapy by 20% in patients deemed “Low Risk.”
From 2004 to 2006, the MircoarRAy PrognoSTics in Breast CancER study, known as RASTER, enrolled 427 women with primary breast carcinoma across 16 community-based hospitals in the Netherlands. The goal of the study was to assess feasibility of implementation and impact on treatment decisions of MammaPrint’s 70—gene prognosis signature. Initial study results, published in The Lancet Oncology in 2007, showed a 20% change in adjuvant treatment decisions after oncologists received MammaPrint diagnostic data.
"While there have been numerous studies that demonstrate the effectiveness of molecular diagnostic tests in identifying patients who are at risk for breast cancer recurrence, today marks the first time that data has been presented assessing the health outcomes of these individuals five years after receiving diagnostic results," said Sabine Linn, Group Leader of the Netherlands Cancer Institute’s Division of Molecular Pathology and an investigator for the RASTER trial. "And the results are very significant."
Specifically, nearly 51% of patients in the study were deemed “Low Risk” for breast cancer recurrence via the MammaPrint assay, and the five-year distant metastasis-free survival (DMFS) rate for those patients was 96.1%. For patients deemed “High Risk” for breast cancer recurrence, the five-year DMFS rate was 89.8% whereby the vast majority of these patients received chemotherapy. The data suggests that it is safe to withhold chemotherapy in low-risk patient groups. The excellent five-year clinical outcome results for both low- and high-risk patients confirms the ability of MammaPrint to accurately stratify patients into appropriate treatment therapies.
"The five-year data from this prospective study clearly shows the promise of personalized medicine," said David Macdonald, CEO of Agendia. "In an era of rising health care costs, MammaPrint informs physicians and patients as to the most effective course of treatment, reducing unnecessary costs and improving patient outcomes."