Gene Expression Assay in the Management of Early Breast Cancer

2020 ◽  
Vol 27 (17) ◽  
pp. 2826-2839 ◽  
Author(s):  
Roberta Caputo ◽  
Daniela Cianniello ◽  
Antonio Giordano ◽  
Michela Piezzo ◽  
Maria Riemma ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Gene Expression ◽  
Decision Making ◽  
Adjuvant Chemotherapy ◽  
Early Breast Cancer ◽  
Treatment Decision ◽  
Endocrine Treatment ◽  
Expression Ratio ◽  
Treatment Decision Making ◽  
Low Sensitivity

The addition of adjuvant chemotherapy to hormonal therapy is often considered questionable in patients with estrogen receptor-positive early breast cancer. Low risk of disease relapse after endocrine treatment alone and/or a low sensitivity to chemotherapy are reasons behind not all patients benefit from chemotherapy. Most of the patients could be exposed to unnecessary treatment- related adverse events and health care costs when treatment decision-making is based only on classical clinical histological features. Gene expression profile has been developed to refine physician’s decision-making process and to tailor personalized treatment to patients. In particular, these tests are designed to spare patients the side effects of unnecessary treatment, and ensure that adjuvant chemotherapy is correctly recommended to patients with early breast cancer. In this review, we will discuss the main diagnostic tests and their potential clinical applications (Oncotype DX, MammaPrint, PAM50/Prosigna, EndoPredict, MapQuant Dx, IHC4, and Theros-Breast Cancer Gene Expression Ratio Assay).

Access to personalized medicine: Factors influencing the use and value of gene expression profiling in treatment decision making.

2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 10-10
Author(s):  
Yvonne Bombard ◽  
Linda Rozmovits ◽  
Maureen E. Trudeau ◽  
Natasha B. Leighl ◽  
Ken Deal ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Gene Expression ◽  
Decision Making ◽  
Gene Expression Profiling ◽  
Expression Profiling ◽  
Clinical Utility ◽  
Perceived Value ◽  
Treatment Decision ◽  
Treatment Decision Making ◽  
Comparison Results

10 Background: Genomic information is increasingly used to personalize health care. One example is gene-expression profiling (GEP) tests that estimate recurrence risk to inform chemotherapy decisions in breast cancer treatment. Recently, GEP tests were publicly funded in Ontario. We assessed the clinical utility of GEP tests, exploring the factors facilitating their use and value in treatment decision-making. Methods: As part of a mixed-methods clinical utility study, we conducted interviews with oncologists (n=14), and focus groups and interviews with breast cancer patients (n=28) who underwent GEP, recruited through oncology clinics in Ontario. Data were analyzed using content analysis and constant comparison. Results: Various factors governing access to GEP have given rise to challenges for patients and oncologists. Oncologists are positioned as gatekeepers of GEP, providing access in medically appropriate cases. However, varying perceptions of appropriateness led to perceived inequities in access and negative impacts on the doctor-patient relationship. Media attention facilitated patient awareness of GEP but complicated gatekeeping. Additional administration burden and long waits for results led to increased patient anxiety and delayed treatment. Collectively, these factors inadvertently heightened GEP’s perceived value for patients relative to other prognostic indicators because of barriers to access. Conclusions: This study delineates the factors facilitating and restricting access to GEP, and highlights the roles of the media and organization of services in GEP’s perceived value and utilization. Results identify a need for administrative changes and practice guidelines to support streamlined and standardized utilization of the test.

Population-based evaluation of 21-gene assay in treatment decision making for early breast cancer in Ontario.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 583-583 ◽  
Author(s):  
Mark Norman Levine ◽  
Brandy Lynn Cochrane ◽  
Jim A. Julian ◽  
Maureen E. Trudeau ◽  
Andrea Eisen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Early Breast Cancer ◽  
Treatment Decision ◽  
Population Based ◽  
Treatment Decision Making ◽  
Gene Assay

Prognostic impact of the inclusion of uPA/PAI-1 tumor levels in the current adjuvant treatment decision-making for early breast cancer

2014 ◽  
Vol 10 (2) ◽  
pp. 195-209 ◽  
Author(s):  
Haïdar Saadoun ◽  
Pierre-Jean Lamy ◽  
Simon Thezenas ◽  
Stéphane Pouderoux ◽  
Frédéric Bibeau ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Early Breast Cancer ◽  
Adjuvant Treatment ◽  
Treatment Decision ◽  
Prognostic Impact ◽  
Treatment Decision Making ◽  
Pai 1

scholarly journals Contribution of the Prosigna® (PAM50) Gene Signature Assay as a New-generation Genomic Test for Treatment Decision-making in Early Breast Cancer

2015 ◽  
Vol 11 (2) ◽  
pp. 85 ◽  
Author(s):  
Nadia Harbeck ◽  
Rachel Wuerstlein ◽  
Karl Sotlar ◽  
◽  
◽  
...  
Keyword(s):  
Breast Cancer ◽  
Decision Making ◽  
Early Breast Cancer ◽  
Cancer Biology ◽  
Treatment Decision ◽  
Gene Signature ◽  
Treatment Decision Making ◽  
Prognostic Gene ◽  
Prognostic Gene Signature ◽  
Post Menopausal

The Prosigna® Breast Cancer Prognostic Gene Signature Assay is based on the characterisation of 50 genes relevant to breast cancer biology and provides intrinsic subtype identification based on the individual tumour biology, a prognostic risk of recurrence (ROR) score and a risk group classification, for each individual patient tested. The Prosigna assay is indicated for post-menopausal women with early-stage hormone receptor-positive breast cancer with or without nodal involvement. Running on the NanoString nCounter® DX Analysis system, which allows direct digital counting of target molecules, the assay offers a simple, reproducible and reliable method to profile many genes simultaneously with high sensitivity and precision. The Prosigna Breast Cancer Prognostic Gene Signature Assay has received 510(k) clearance from the US Food and Drug Administration. It has also received a CE mark and is available for use, among other geographical areas, in the EU, Israel and parts of the Middle East, through qualified local pathology laboratories. The de-centralised testing enables timely result delivery and direct interaction between the laboratory pathologists and treating physicians. The analytical reproducibility, precision and robustness of Prosigna have been demonstrated. Moreover, it has been clinically validated in two independent prospectiveretrospective studies using >2,400 samples from post-menopausal patients enrolled in the Austrian Breast & Colorectal Cancer Study Group 8 (ABCSG 8) and Arimidex, Tamoxifen Alone or Combined (ATAC) trials (Level 1B Evidence). These validation studies show that Prosigna identifies a clinically relevant low-risk subgroup among both node-negative and node-positive patients with 1-3 involved lymph nodes. Moreover, the ROR score predicts risk of late distant recurrence as well as for high risk of local recurrence. Prosigna thus can offer clinically relevant information, which may help guide treatment decision-making in early breast cancer.

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