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Original article

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

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Pages 1129-1137 | Accepted 31 Mar 2015, Published online: 23 Apr 2015
 

Abstract

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.

Transparency

Declaration of funding

This work was financially supported by Nanostring Technologies Inc. The company participated in the interpretation of data, review, and approval of the manuscript. The authors did not receive financial or professional help with the preparation of the manuscript.

Declaration of financial/other relationships

M.M. has disclosed that he has been a consultant for Novartis, Roche, Genentech, Celgene, and AstraZeneca. J.H.-R., A.G.-M., and L.C.-M. have disclosed that they are consultants for Roche. L.C.-M and J.H.-R. have disclosed that they have been consultants for AstraZeneca. J.H.-R. has disclosed that he has been a consultant for Pfizer, Novartis, and Agendia. A.G.-M. has disclosed that he has been a consultant for Amgen and Pharmamar. S.Mi. and J.H. have disclosed that they are employees of Cedar Associates LLC, which has received research support from NanoString Technologies Inc. for the work that was performed. A.P. has disclosed that he has been a consultant for NanoString Technologies Inc. S.F. and K.P. have disclosed that they are employees of NanoString Technologies Inc. M.G.-R., S.Mo., L.G.-C., L.M., J.A., S.G., A.A., F.R., M.V., P.G., E.A., C.M., M.C., R.C., U.G., and E.C. have disclosed that they have no significant relationships with or financial interests in any commercial companies related to this study or article. All authors meet ICMJE criteria for authorship. M.M. is the guarantor.

CMRO peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Acknowledgments

The authors thank Nanostring Technologies Inc. for financial support of this study.

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