Journal Article
. 2015 Apr; 31(6):1129-37.
doi: 10.1185/03007995.2015.1037730.

Prospective study of the impact of the Prosigna assay on adjuvant clinical decision-making in unselected patients with estrogen receptor positive, human epidermal growth factor receptor negative, node negative early-stage breast cancer

Miguel Martín 1 Milagros González-Rivera  Serafín Morales  Juan de la Haba-Rodriguez  Lucía González-Cortijo  Luis Manso  Joan Albanell  Antonio González-Martín  Sónia González  Angels Arcusa  Luis de la Cruz-Merino  Federico Rojo  María Vidal  Patricia Galván  Elena Aguirre  Cristina Morales  Sean Ferree  Kristen Pompilio  Maribel Casas  Rosalía Caballero  Uxue Goicoechea  Eva Carrasco  Steven Michalopoulos  John Hornberger  Aleix Prat  
  • PMID: 25851308
  •     8 citations


Purpose: Improved understanding of risk of recurrence (ROR) is needed to reduce cases of recurrence and more effectively treat breast cancer patients. The purpose of this study was to examine how a gene-expression profile (GEP), identified by Prosigna, influences physician adjuvant treatment selection for early breast cancer (EBC) and the effects of this influence on optimizing adjuvant treatment recommendations in clinical practice.

Methods: A prospective, observational, multicenter study was carried out in 15 hospitals across Spain. Participating medical oncologists completed pre-assessment, post-assessment, and follow-up questionnaires recording their treatment recommendations and confidence in these recommendations, before and after knowing the patient's ROR. Patients completed questionnaires on decision-making, anxiety, and health status.

Results: Between June 2013 and January 2014, 217 patients enrolled and a final 200 were included in the study. Patients were postmenopausal, estrogen receptor positive, human epidermal growth hormone factor negative, and node negative with either stage 1 or stage 2 tumors. After receiving the GEP results, treatment recommendations were changed for 40 patients (20%). The confidence of medical oncologists in their treatment recommendations increased in 41.6% and decreased in 6.5% of total cases. Patients reported lower anxiety after physicians made treatment recommendations based on the GEP results (p < 0.05).

Conclusions: Though this study does not include evaluation of the impact of GEP on long-term outcomes, it was found that GEP results influenced the treatment decisions of medical oncologists and their confidence in adjuvant therapy selection. Patients' anxiety about the selected adjuvant therapy decreased with use of the GEP.

Keywords: Adjuvant; Breast cancer; Genomic; Intrinsic subtypes; PAM50; Prosigna.

Limitations in predicting PAM50 intrinsic subtype and risk of relapse score with Ki67 in estrogen receptor-positive HER2-negative breast cancer.
Aranzazu Fernandez-Martinez, Tomás Pascual, +30 authors, Miguel Martin.
Oncotarget, 2017 Apr 21; 8(13). PMID: 28423537    Free PMC article.
Prospective, multicenter French study evaluating the clinical impact of the Breast Cancer Intrinsic Subtype-Prosigna® Test in the management of early-stage breast cancers.
Delphine Hequet, Céline Callens, +20 authors, Roman Rouzier.
PLoS One, 2017 Oct 19; 12(10). PMID: 29045452    Free PMC article.
Prognostic value of PAM50 and risk of recurrence score in patients with early-stage breast cancer with long-term follow-up.
Hege O Ohnstad, Elin Borgen, +11 authors, Bjørn Naume.
Breast Cancer Res, 2017 Nov 16; 19(1). PMID: 29137653    Free PMC article.
Biomarkers in breast cancer: A consensus statement by the Spanish Society of Medical Oncology and the Spanish Society of Pathology.
R Colomer, I Aranda-López, +7 authors, J Palacios-Calvo.
Clin Transl Oncol, 2017 Dec 24; 20(7). PMID: 29273958    Free PMC article.
Prognostic value of circulating microRNAs in upper tract urinary carcinoma.
Ruth Montalbo, Laura Izquierdo, +4 authors, Lourdes Mengual.
Oncotarget, 2018 Apr 24; 9(24). PMID: 29682178    Free PMC article.
Gene Expression Profiling Tests for Early-Stage Invasive Breast Cancer: A Health Technology Assessment.
Ontario Health (Quality).
Ont Health Technol Assess Ser, 2020 Apr 15; 20(10). PMID: 32284770    Free PMC article.
Patients' perceptions of 70-gene signature testing: commonly changing the initial inclination to undergo or forego chemotherapy and reducing decisional conflict.
Julia E C van Steenhoven, Bianca M den Dekker, +6 authors, Thijs van Dalen.
Breast Cancer Res Treat, 2020 May 21; 182(1). PMID: 32430679    Free PMC article.
A Pathology-Based Combined Model to Identify PAM50 Non-luminal Intrinsic Disease in Hormone Receptor-Positive HER2-Negative Breast Cancer.
Tomás Pascual, Miguel Martin, +21 authors, Aleix Prat.
Front Oncol, 2019 May 21; 9. PMID: 31106144    Free PMC article.