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J Clin Oncol. 2015 Aug 20;33(24):2695-704. doi: 10.1200/JCO.2015.61.1459. Epub 2015 Jul 20.

Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.

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Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI; Mark R. Somerfield, American Society of Clinical Oncology, Alexandria, VA; Robert C. Bast, Ana M. Gonzalez-Angulo, and William F. Symmans, University of Texas MD Anderson Cancer Center, Houston; Robert G. Mennel, Texas Oncology, Dallas, TX; Massimo Cristofanilli, Thomas Jefferson University-Kimmel Cancer Center, Philadelphia, PA; Matthew P. Goetz and Minetta C. Liu, Mayo Clinic, Rochester, MN; David G. Hicks, University of Rochester Medical Center, Rochester, NY; Elizabeth G. Hill, Medical University of South Carolina, Hollings Cancer Center, Charleston, SC; Wanda Lucas, Georgetown University, Washington, DC; Ingrid A. Mayer, Vanderbilt University Medical Center and Vanderbilt-Ingram Cancer Center, Nashville, TN; and Lyndsay N. Harris, Seidman Cancer Center, Case Western Reserve University, Cleveland, OH.



To provide recommendations on the appropriate use of breast tumor biomarker assay results to guide decisions on systemic therapy for metastatic breast cancer.


A literature search and prospectively defined study selection identified systematic reviews, meta-analyses, randomized controlled trials (RCTs), prospective-retrospective studies, and prospective comparative observational studies published from 2006 through September 2014.


The literature search revealed 17 articles that met criteria for further review: 11 studies reporting discordances between primary tumors and metastases in expression of hormone receptors or human epidermal growth factor receptor 2 (HER2), one RCT that addressed the use of a biomarker to decide whether to change or continue a treatment regimen, and five prospective-retrospective studies that evaluated the clinical utility of biomarkers.


In patients with accessible metastases, biopsy for confirmation of disease process and retesting of estrogen receptor, progesterone receptor, and HER2 status should be offered, but evidence is lacking to determine whether changing anticancer treatment on the basis of change in receptor status affects clinical outcomes. With discordance of results between primary and metastatic tissues, the Panel consensus is to use preferentially the estrogen receptor, progesterone receptor, and HER2 status of the metastasis to direct therapy if supported by the clinical scenario and patient's goals for care. Carcinoembryonic antigen, cancer antigen 15-3, and cancer antigen 27-29 may be used as adjunctive assessments, but not alone, to contribute to decisions regarding therapy. Recommendations for tumor rebiopsy and use of circulating tumor markers are based on clinical experience and Panel informal consensus in the absence of studies designed to evaluate the clinical utility of the markers. As such, it is also reasonable for clinicians to not use these markers as adjunctive assessments.

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