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Dec 5, 2017 12:59PM
Dec 5, 2017 01:21PM
I believe that your team was saying that in your specific situation, with 17/21 positive lymph nodes, the Oncotype and MammaPrint tests are not within your local guidelines. This would also be the case in the USA, Canada, and the UK, considering lymph node status alone. The various guidelines do not differ in that regard (with more than three positive lymph nodes).
Amelia received case-specific advice that she is not eligible for either the OncotypeDX ("21-gene") test or the MammaPrint ("70-gene") test. These tests would not be indicated for a person with 17 positive lymph nodes under applicable consensus guidelines in the US or under formal eligibility criteria from the test providers either.
Other patients in Europe with different pathologic features may indeed be eligible for and may receive the MammaPrint test under their local consensus guidelines. Patients should seek case-specific advice from their Medical Oncologist, any may be interested in consulting the current texts of their local guidelines for their information. Multiple guidelines may be in play, including regional European as well as national guidelines. The policies of health authority payors may be a separate question.
ESMO's guideline (European Society for Medical Oncology) for primary breast cancer in 2015 provided very generally:
"Gene expression profiles, such as MammaPrint (Agendia, Amsterdam, the Netherlands), Oncotype DX Recurrence Score (Genomic Health, Redwood City, CA), Prosigna (Nanostring technologies, Seattle, WA) and Endopredict (Myriad Genetics), may be used to gain additional prognostic and/or predictive information to complement pathology assessment and to predict the benefit of adjuvant chemotherapy. The three latter tests are designed for patients with ER-positive early breast cancer only. The clinical utility of Mammaprint and Oncotype DX is still being prospectively evaluated in large randomised clinical trials such as MINDACT for Mammaprint, WSG PLAN B trial, TAILORx and RxPONDER for Oncotype DX."
Since the, the primary results of MINDACT have been published and local guidelines may have changed. See for example, this press release from Agendia (the provider of the MammaPrint test).
More recently, the St. Gallen International panel noted in 2017:
"The Panel agreed that a number of gene expression signatures served as prognostic markers in the setting of adjuvant endocrine therapy in node-negative breast cancers, including the 21 gene [OncotypeDX] recurrence score, the 70 gene [MammaPrint] signature, the PAM50 ROR score, the EpClin score, and the Breast Cancer Index. The Panel endorsed all of these assays for guiding the decision on adjuvant chemotherapy in node-negative tumors as they all identify node-negative cases at low risk, with an excellent prognosis that would not warrant chemotherapy [23–27]. [NOTE: Our local ASCO guidelines are more nuanced than this, and do not broadly support the use of the MammaPrint test in all cases.]
Nodal status is a strong prognostic factor regardless of gene expression signature. The Panel agreed that gene expression signatures offered information that can refine the prognosis for node-positive breast cancers. However, the Panel did not uniformly endorse the use of gene expression signatures for making treatment decisions regarding adjuvant chemotherapy in node-positive cases. The 21-gene recurrence score and the 70-gene signature have now been evaluated in prospective studies including small numbers of node-positive cancers. In the prospective trial (MINDACT), only patients with node-negative, or one to three positive nodes were included. Patients with low-risk tumor scores and a limited degree of nodal involvement appear to have a good prognosis with or without chemotherapy [28, 29]."
In the US, the various guidelines from ASCO and NCCN also differ somewhat in what they provide regarding the use of these tests node-negative versus node-positive disease. Here as well, patients should seek current, case-specific expert professional advice from their Medical Oncologist.
Stage IA IDC, 9/2013 BMX. Right: IDC (1.5 mm, grade 2) with DCIS (5+ cm), 0/4 nodes, pN0. Left: DCIS (5+ cm), 0/1 node, pN0(i+).