Use of biomarkers to guide decisions on adjuvant systemic therapy forwomenwith early-stage invasive breast cancer: American Society of clinical Oncology clinical practice guideline

Lyndsay N. Harris, Nofisat Ismaila, Lisa M. McShane, Fabrice Andre, Deborah E. Collyar, Ana M. Gonzalez-Angulo, Elizabeth H. Hammond, Nicole M. Kuderer, Minetta C. Liu, Robert G. Mennel, Catherine Van Poznak, Robert C. Bast, Daniel F. Hayes

Research output: Contribution to journalArticle

401 Scopus citations

Abstract

Purpose: To provide recommendations on appropriate use of breast tumor biomarker assay results to guide decisions on adjuvant systemic therapy for women with early-stage invasive breast cancer. Methods: A literature search and prospectively defined study selection sought systematic reviews, metaanalyses, randomized controlled trials, prospective-retrospective studies, and prospective comparative observational studies published from 2006 through 2014. Outcomes of interest included overall survival and disease-free or recurrence-free survival. Expert panel members used informal consensus to develop evidence-based guideline recommendations. Results: The literature search identified 50 relevant studies. One randomized clinical trial and 18 prospectiveretrospective studies were found to have evaluated the clinical utility, as defined by the guideline, of specific biomarkers for guiding decisions on the need for adjuvant systemic therapy. No studies that met guideline criteria for clinical utility were found to guide choice of specific treatments or regimens. Recommendations: In addition to estrogen and progesterone receptors and human epidermal growth factor receptor 2, the panel found sufficient evidence of clinical utility for the biomarker assays Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1 in specific subgroups of breast cancer. No biomarker except for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 was found to guide choices of specific treatment regimens. Treatment decisions should also consider disease stage, comorbidities, and patient preferences.

Original languageEnglish (US)
Pages (from-to)1134-1150
Number of pages17
JournalJournal of Clinical Oncology
Volume34
Issue number10
DOIs
StatePublished - Apr 1 2016

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Harris, L. N., Ismaila, N., McShane, L. M., Andre, F., Collyar, D. E., Gonzalez-Angulo, A. M., Hammond, E. H., Kuderer, N. M., Liu, M. C., Mennel, R. G., Van Poznak, C., Bast, R. C., & Hayes, D. F. (2016). Use of biomarkers to guide decisions on adjuvant systemic therapy forwomenwith early-stage invasive breast cancer: American Society of clinical Oncology clinical practice guideline. Journal of Clinical Oncology, 34(10), 1134-1150. https://doi.org/10.1200/JCO.2015.65.2289