AMSTERDAM, The Netherlands, Dec. 14 New researchdemonstrates that the MammaPrint(R) breast cancer prognosis test wassuccessfully implemented in the diagnostic process of breast cancer patientsin community hospitals in The Netherlands. MammaPrint(R) assigned up to one-third of the patients to different risk categories as compared to currentlyused risk assessment tools. In the majority of these situations, it may leadto a reduction in the use of adjuvant chemotherapy. The findings werepublished in the December issue of The Lancet Oncology.
In the study, breast tumors from 585 patients with lymph node-negative,invasive breast cancer, collected at 16 hospitals in The Netherlands. Freshsamples were shipped in RNAretain(R)* at ambient temperature and weresubjected at Agendia Laboratories to MammaPrint(R) gene expression analysis.Results were available for 427 patients. Based on this, patients wereclassified as having either a poor prognosis (high risk for distantmetastasis) or good prognosis (low risk for metastasis). These results werethen compared by the study coordinators to risk assessments of commonly usedguidelines, including the Dutch Institute for Health Improvement (Dutch CBO)Guidelines, St. Gallen Guidelines, Nottingham Prognostic Index, and Adjuvant!Online. Many guidelines use algorithms (based on the patient's age, tumorsize, and node status) to determine a patient's prognosis and determinewhether or not patients should receive chemotherapy.
"More than 70 percent of patients who have node-negative breast cancer aresuccessfully treated without chemotherapy. Identifying which patients withbreast cancer will most likely require adjuvant chemotherapy is an importantstep in personalizing a patient's treatment regimen, and ensuring thatpatients aren't receiving unnecessary treatment," said Dr Laura van 't Veer,chief research officer at Agendia, who participated in the study.
According to the results in The Lancet Oncology, adjuvant chemotherapy wasadvised less often when the patient's prognosis was based on the DUTCH CBOGuidelines -- which are considered the most restrictive -- compared withassessments based on MammaPrint(R). For the other guidelines assessed,however, less adjuvant therapy would be given based on the prognosis ofMammaPrint(R). These results confirm previous findings and validations withthe test.
"These data provide important information to patients and physicians thatcan effectively help guide treatment decisions in community-based hospitals.The prognosis provided by MammaPrint(R), together with guidance from clinicalguidelines and patients' treatment preferences, are vital tools for physicianscaring for breast cancer patients," said Bernhard Sixt, chief executiveofficer at Agendia.
MammaPrint(R) laboratory service is the first and only FDA cleared(February 2007) DNA microarray-based 'in vitro diagnostic multivariate indexassay' (IVDMIA). MammaPrint(R) measures the activity of 70 genes, providinginformation about the likelihood of tumor recurrence. The MammaPrint(R) testmeasures the level of expression of each of these genes in a sample of awoman's surgically-removed breast cancer tumor and then uses a specificformula or algorithm to produce a score that determines whether the patient isdeemed low risk or high risk for spread of the cancer to another site. Theresult may help a doctor in planning treatment and appropriate follow-up for apatient when used with other clinical information and laboratory tests. AllMammaPrint(R) tests are conducted in Agendia's CLIA-certified central servicelaboratory.
Agendia, located in Amsterdam, The Netherlands, is a world leader in geneexpression analysis-based diagnostics with three products on the market. Thecompany focuses on the development and commercialization of diagnostic testsusing tumor gene e