title: Use of Biomarkers to Guide Decisions on Systemic Therapy for Women With Metastatic Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.
abstract: OBJECTIVE
  To provide recommendations on the appropriate use of breast tumor biomarker assay results to guide decisions on systemic therapy for metastatic breast cancer.
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Catherine
authors.initials: C
authors.lastname: Van Poznak
authors.affiliation: 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.
authors.forename: Mark R
authors.initials: MR
authors.lastname: Somerfield
authors.affiliation: 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.
authors.forename: Robert C
authors.initials: RC
authors.lastname: Bast
authors.affiliation: 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.
authors.forename: Massimo
authors.initials: M
authors.lastname: Cristofanilli
authors.affiliation: 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.
authors.forename: Matthew P
authors.initials: MP
authors.lastname: Goetz
authors.affiliation: 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.
authors.forename: Ana M
authors.initials: AM
authors.lastname: Gonzalez-Angulo
authors.affiliation: 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.
authors.forename: David G
authors.initials: DG
authors.lastname: Hicks
authors.affiliation: 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.
authors.forename: Elizabeth G
authors.initials: EG
authors.lastname: Hill
authors.affiliation: 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.
authors.forename: Minetta C
authors.initials: MC
authors.lastname: Liu
authors.affiliation: 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.
authors.forename: Wanda
authors.initials: W
authors.lastname: Lucas
authors.affiliation: 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.
authors.forename: Ingrid A
authors.initials: IA
authors.lastname: Mayer
authors.affiliation: 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.
authors.forename: Robert G
authors.initials: RG
authors.lastname: Mennel
authors.affiliation: 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.
authors.forename: William F
authors.initials: WF
authors.lastname: Symmans
authors.affiliation: 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.
authors.forename: Daniel F
authors.initials: DF
authors.lastname: Hayes
authors.affiliation: 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.
authors.forename: Lyndsay N
authors.initials: LN
authors.lastname: Harris
mesh_terms: D014408:Biomarkers, Tumor / Q000032:analysis* / Q000378:metabolism; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000378:metabolism / Q000473:pathology / Q000628:therapy*; D005260:Female; D006801:Humans; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D014481:United States
chemical_list: D014408:Biomarkers, Tumor