The updated National Comprehensive Cancer Network® (NCCN) Clinical Practice Guidelines in Oncology – Breast Cancer Version 1.2023, have recognize and included Agendia’s MammaPrint UltraLow Risk result and its proven impact on patient care.

MammaPrint® is a 70-gene prognostic test that, along with other clinicopathologic factors, determines a specific patient’s breast cancer recurrence risk and can help physicians to objectively select the best treatment plan.

This inclusion is particularly critical for women with early-stage breast cancer who receive an UltraLow Risk test result and can safely forgo toxic treatments yet maintain excellent chance of survival. The NCCN’s recognition of this risk category will enable clinicians to confidently identify which tumors have an exceedingly low risk of distant metastasis, ultimately empowering them and their patients to determine the best possible path towards a cure while minimizing unnecessary treatment with chemotherapy [1] and endocrine therapy. [2]

Breast cancer is extremely complex, with each tumor having its own biology, clinical behavior, and therapy. Providers need more than what pathology alone can offer to navigate this complexity, yet many conventional tests use broad stroke risk assessments with inherent blind spots. MammaPrint is the only FDA-cleared test that can identify very low risk (UltraLow Risk) tumors, which are proven to have excellent outcomes with de-escalated treatment plans. With the NCCN Guidelines recognizing the value of the MammaPrint UltraLow Risk data, clinicians can further personalize care for these women and avoid over treatment. The updated Guidelines showcase strong evidence that supports the clinical utility of a MammaPrint UltraLow Risk result, including:

  • Identifying women with early-stage breast cancer who can safely forgo chemotherapy. NCCN highlights a peer-reviewed publication in The Journal of Clinical Oncology, which stems from Agendia’s randomized control trial, MINDACT, where women with an UltraLow Risk result showed an 8-year breast cancer specific survival (BCSS) above 99%. [1] Furthermore, the supplement to the publication included data by age [3] and found the majority of the premenopausal women with a MammaPrint UltraLow Risk result and did not undergo chemotherapy had an excellent distant metastasis free interval (DMFI) at 5 years of 97.1%. [2] This means it is possible for these women to be spared the serious and often life-threatening long-term effects of chemotherapy, including the potential loss of fertility.
  • Identifying postmenopausal women with early-stage breast cancer who can safely discontinue endocrine therapy after 2-5 years.* NCCN also now cites a study in JAMA Oncology that found 20 years after their diagnosis, postmenopausal women with early-stage breast cancer had a 97% BCSS rate with 2-5 years of tamoxifen. [2] This allows clinicians to identify those who can safely discontinue endocrine therapy early and avoid unnecessary toxicity.*

Unnecessary treatment
“Whether it’s chemotherapy or endocrine therapy, no woman should unnecessarily endure treatment and its potential long-term impacts unnecessarily. However, relying on pathologic insights alone can lead to overtreatment. This recognition from the prestigious NCCN acknowledges the robust evidence of MammaPrint’s UltraLow Risk assessment, enabling providers to deliver more personalized care, and allowing women to feel confident they can safely avoid certain treatments and the consequential toxicity,” said Suzanne A Hoekstra, MD, FACS, at Northern Light Mercy Breast Care.

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“The MammaPrint UltraLow Risk data are now recognized by NCCN Guidelines, supporting the value of MammaPrint testing to identify these women with an UltraLow Risk of distant metastasis,” said William Audeh, MD, Chief Medical Officer of Agendia.

“The clinical implications of an UltraLow Risk result are significant, allowing women and their clinicians to consider reducing endocrine therapy in the face of toxicity, for postmenopausal women, as well as avoiding unnecessary chemotherapy, for premenopausal women, while still experiencing excellent outcomes, free of breast cancer,” Audeh concluded.

Additional risk categories
In addition to Agendia’s UltraLow gene expression profile, the MammaPrint test also stratifies breast cancer tumors into additional risk categories. Each of these proprietary signatures was developed through a robust analysis of the RNA signal from 70 different genes in the tumor, each of which helps guide personalized treatment plans for that individual tumor, rather than being based on the cancer type of the average woman.

When MammaPrint is combined with Agendia’s BluePrint® test, clinicians also get an assessment of the dominant pathway driving the tumor’s growth. With biology-based insights provided by Agendia’s tests, clinicians can uncover the underlying diversity of every tumor, and in turn, make precise decisions with their patients, that both can rely on.

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Note: *In lymph node-negative patient type.

Clinical trials
Genetic Testing or Clinical Assessment in Determining the Need for Chemotherapy in Women With Breast Cancer That Involves No More Than 3 Lymph Nodes (MINDACT) – NCT00433589

[1] Lopes Cardozo JMN, Drukker CA, Rutgers EJT, Schmidt MK, Glas AM, Witteveen A, Cardoso F, Piccart M, Esserman LJ, Poncet C, van ‘t Veer LJ. Outcome of Patients With an Ultralow-Risk 70-Gene Signature in the MINDACT Trial. J Clin Oncol. 2022 Apr 20;40(12):1335-1345. doi: 10.1200/JCO.21.02019. Epub 2022 Jan 21. PMID: 35061525.
[2] Esserman LJ, Yau C, Thompson CK, van ‘t Veer LJ, Borowsky AD, Hoadley KA, Tobin NP, Nordenskjöld B, Fornander T, Stål O, Benz CC, Lindström LS. Use of Molecular Tools to Identify Patients With Indolent Breast Cancers With Ultralow Risk Over 2 Decades. JAMA Oncol. 2017 Nov 1;3(11):1503-1510. doi: 10.1001/jamaoncol.2017.1261. Erratum in: JAMA Oncol. 2017 Nov 1;3(11):1589. PMID: 28662222; PMCID: PMC5710197.
[3] Lopes Cardozo J, et al. Outcomes of patients with an ultralow-risk 70-gene signature in the MINDACT trial. J Clin Oncol. 2022 Apr; Supplement.

Featured image: Doctor discussing treatment options with a patient. Photo courtesy: © 2016 – 2023 Fotolia/Adobe. Used with permission

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