On December 12, 2019 Agendia, Inc., a world leader in precision oncology for breast cancer, reported new data comparing genomic profiling results for patients under the age of 50 with early-stage breast cancer (Press release, Agendia, DEC 12, 2019, View Source [SID1234552332]). The data, which are being presented for the first time today at the 2019 San Antonio Breast Cancer Symposium (SABCS), show that the MammaPrint 70-gene assay may more effectively identify premenopausal women who may safely avoid chemotherapy.
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One of the biggest challenges physicians face when treating patients with early stage, curable breast cancer is choosing a treatment path that will mitigate the risk of disease recurrence, while avoiding over- or undertreatment. Genomic profiling has helped address this clinical need, but recent findings suggest age may impact the veracity of results for some assays. A follow up to the TAILORx study published in 2018 led to a change in recurrence score (RS) stratification for patients under 50 and, more importantly, left the ideal treatment plan for those with a RS of 21-25 unclear.
"Understanding how patient age may affect possible benefit from chemotherapy is a critically important question that has needed further exploration and clarification," said William Audeh, MD, MS, chief medical officer, Agendia.
The Agendia Prospective Study of MammaPrint in Breast Cancer Patients with an Intermediate Recurrence Score (PROMIS) trial previously demonstrated that MammaPrint, which provides a binary, High Risk or Low Risk of recurrence, delivers clinically actionable results for patients who receive a RS of 18-30 by the 21-gene assay. The findings presented today at SABCS represent a sub-analysis of the PROMIS data, which Agendia conducted to help determine the potential of the MammaPrint test to clarify adjuvant chemotherapy decisions for premenopausal women.
Results – which are statistically significant – demonstrate that 58 percent of women age 50 and under with RS 18-20 and 46 percent of those with RS 21-25 are categorized as MammaPrint Low, indicating that they may safely forgo chemotherapy. Additionally, 15 percent of women with RS 26-30 were found to be MammaPrint Low Risk and may be potential candidates for de-escalation of adjuvant chemotherapy.
"Treatment recommendations in ER+ patients <50 years: Comparison of the 21-gene assay and 70-gene signature in the PROMIS study" can be found at: View Source