SAN ANTONIO — The 70-gene MammaPrint prognosis signature independently identifies a genomic low-risk subgroup of HER2-positive early breast cancer patients likely to have a good long-term clinical outcome, even without adjuvant trastuzumab and chemotherapy.
Dr. Michael Knauer of the Netherlands Cancer Institute, Amsterdam, presented a validation study of 169 women with HER2-positive unilateral breast cancer drawn from six partially published studies. All of the women had T1–3 N0-1 disease; 46% received chemotherapy and 15% got trastuzumab.
MammaPrint classified 16% of the tumors as having a “good prognosis” signature, Dr. Knauer said at the San Antonio Breast Cancer Symposium. Those 27 patients had a 10-year distant disease-free survival rate of 89%. The 142 patients classified by MammaPrint as having a high genomic risk had a 10-year distant disease-free survival of 64%.
In a multivariate analysis adjusted for the conventional prognostic factors along with adjuvant therapies, the Mamma- Print signature and tumor size were the only independent predictors of 10-year distant disease-free survival. Mamma-Print was the stronger predictor of the two; a “poor prognosis” MammaPrint result was associated with a 5.4-fold increased risk of distant recurrence within 10 years, compared with a favorable MammaPrint signature. In the subset of 90 patients who didn't receive adjuvant trastuzumab or chemotherapy, a poor prognosis Mamma- Print result conferred a 4.75-fold greater risk of distant relapse within 10 years.
Agendia Inc., which markets Mamma- Print, supported the study. Dr. Knauer said he has no financial conflicts of interest regarding the study.