IRVINE, Calif. & AMSTERDAM--(BUSINESS WIRE)--Agendia, Inc., a world leader in personalized medicine and molecular cancer diagnostics, announces that the 15th St. Gallen International Breast Cancer Guidelines recently published in Annals of Oncology1 have recommended the MammaPrint® 70-Gene Breast Cancer Risk-of-Recurrence Test for the third time to help guide treatment decision-making for patients with early-stage breast cancer.

The 2017 update expands the panel’s consensus on MammaPrint to include its use as a prognostic tool to make treatment decisions for adjuvant (post-surgery) chemotherapy in patients with lymph-node positive breast cancer.

The biennial guidelines noted the MammaPrint test has now been evaluated in a prospective study. The results of the Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy (MINDACT) clinical trial, published in August 2016,2 provided the prospective data that demonstrated patients with a MammaPrint “low risk result and a limited degree of lymph node involvement appear to have a good prognosis with or without chemotherapy.” Only one other gene-expression test was recommended for guiding treatment decisions for lymph-node positive patients.
Lymph-node positive patients are often the most likely to be classified at high risk of their cancer recurring using clinical factors like age and tumor size. However, data from the MINDACT trial found that more than 60% of patients were reclassified as genomic Low Risk using MammaPrint, and did not show a significant benefit from chemotherapy.

With the new 2017 St. Gallen guidelines, MammaPrint continues to be recommended to guide adjuvant chemotherapy decisions in patients with tumors with no affected lymph nodes (lymph-node negative) and as a prognostic marker to aid treatment decisions in adjuvant endocrine (hormone) therapy in lymph-node negative patients.

Importantly, the updated St. Gallen guidelines also recommended changes from its prior guidance3 for the 21-gene recurrence score’s cut-off to avoid chemotherapy, which was lowered from RS<25. In intermediate risk patients with a recurrence score from 12-24, it was suggested to consider adding adjuvant chemotherapy. Similarly, the AJCC (American Joint Committee on Cancer) recently updated its 8th edition manual only recommending use of the recurrence score <11 as providing sufficient evidence to be included, which only accounts for approximately 16% of breast cancer patients.4

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