Agendia has announced that a study demonstrating the direct predictive ability of its breast cancer recurrence test, MammaPrint®, has been published in Breast Cancer Research and Treatment. Additionally, the study authors have been invited to present the data at the American Association for Cancer Research’s 2009 Annual Meeting in Denver.
"Our multi-study pool of patient data is maturing quickly and this is the first of a number of forthcoming publications showing MammaPrint’s direct predictive ability for neoadjuvant and adjuvant chemotherapy regimens," commented Dr Bernhard Sixt, PhD, President and Chief Executive Officer.
"These findings considerably add to MammaPrint’s well-established indirect predictive evidence for any chemotherapy, since MammaPrint is highly prognostic for early metastasis risk. Only early metastasis risk can be reduced by chemotherapy as shown by the Early Breast Cancer Trialists’ Collaborative Group in their most recent 5-year update. These new findings will further support our ongoing discussions with payers and guideline committees."
The study directly addresses a major concern expressed in an excellent review on the impact of tumor gene expression profiling outcomes in patients with breast cancer recently published by the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. In its recommendations EGAPP is particularly concerned by the lack of direct evidence linking tumor gene expression profiling to improved outcomes. The current study provides this evidence for MammaPrint and persuasively establishes this link.
About the study
The study was performed in collaboration with the Netherlands Cancer Institute and analyzed the association between the pathological complete response (pCR) rate and the results of the MammaPrint test. The achievement of pCR is a valuable indicator for long-term response in this clinical setting.
A consecutive series of 167 patients who received neoadjuvant chemotherapy for stage II or III breast cancer was analyzed to assess MammaPrint’s predictive power. 20% of the 144 patients in the high risk group achieved a pCR, whereas none of the patients in the low risk group achieved a pCR. After a median follow-up of 25 months, 17 relapses were seen in the high-risk group and none in the low risk group. These findings demonstrate that tumors with a high risk MammaPrint signature are sensitive to chemotherapy.