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| |  MammaPrint Genomic Assay Predicts Outcomes in Node-Positive Breast Cancer: Presented at SABCS By John Gever SAN ANTONIO, TX -- December 16, 2007 -- A 70-gene prognostic assay (MammaPrint) for node-negative, early-stage breast cancer predicts later metastasis in women with node-positive disease, according to a preliminary clinical trial. In addition, the study found that the assay has predictive value in identifying node-positive patients who would not benefit from adjuvant chemotherapy. The results were presented here on December 13 in a poster session at the 30th Annual San Antonio Breast Cancer Symposium (SABCS) by Stella Mook, MD, Oncology Fellow, Netherlands Cancer Institute, Amsterdam, The Netherlands. If the findings are confirmed in subsequent studies, many more women would be able to benefit from the genomic test than is now the case. The assay classifies women as being at high or low risk for developing distant metastases, based on expression levels of 70 target genes. The study included 106 women with one to three positive lymph nodes who had participated in earlier research on the 70-gene assay. They had primary invasive breast carcinoma measuring less than 5 cm in diameter and underwent mastectomy or breast-conserving surgery. With a median of 10.3 years of follow-up, an overall survival hazard ratio of 5.3 was found for high-risk versus low-risk patients (95% confidence interval [CI]: 1.2-22.5; P =.025). For distant metastasis as the first event, the hazard ratio was 4.4 (95% CI: 1.1-17.4; P =.035). The researchers also found that patients at low risk according to the assay obtained no apparent benefit from adjuvant chemotherapy. "Although 70% of the patients received adjuvant chemotherapy, there is no significant difference between patients with a good prognosis signature [who were] treated and those who were not treated with chemotherapy," they said. "Incorporation of the 70-gene profile in clinical decision-making for patients with 1 to 3 positive nodes may lead to reconsideration of adjuvant chemotherapy," they added. The assay classified 41% of patients as having a good prognosis and 59% as being at high risk. Those in the good-prognosis group had a 10-year overall survival probability of 98% compared with 64% in those with a poor prognosis. The probability of having distant metastases by year 10 was 5% in low-risk patients and 30% in those at high risk. "We are currently validating these results in an independent sample series," the group said. They then plan to confirm it prospectively with patients having one to three positive nodes in the ongoing Microarray In Node negative Disease may Avoid ChemoTherapy study now underway in Europe.
[Presentation title: The Amsterdam 70-Gene Signature Predicts Outcome in Breast Cancer Patients With 1-3 Positive Axillary Lymph Nodes. Abstract 1064]
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