title: Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.
abstract: OBJECTIVE
  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, meta-analyses, 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 prospective-retrospective 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.
  
  
  CONCLUSIONS
  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.
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.
authors: Lyndsay N
authors: LN
authors: Harris
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI. guidelines@asco.org.
authors: Nofisat
authors: N
authors: Ismaila
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.
authors: Lisa M
authors: LM
authors: McShane
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.
authors: Fabrice
authors: F
authors: Andre
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.
authors: Deborah E
authors: DE
authors: Collyar
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.
authors: Ana M
authors: AM
authors: Gonzalez-Angulo
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.
authors: Elizabeth H
authors: EH
authors: Hammond
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.
authors: Nicole M
authors: NM
authors: Kuderer
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.
authors: Minetta C
authors: MC
authors: Liu
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.
authors: Robert G
authors: RG
authors: Mennel
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.
authors: Catherine
authors: C
authors: Van Poznak
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.
authors: Robert C
authors: RC
authors: Bast
authors: Lyndsay N. Harris, Case Western Reserve University, Cleveland, OH; Nofisat Ismaila, American Society of Clinical Oncology, Alexandria, VA; Lisa M. McShane, National Cancer Institute, Bethesda, MD; Fabrice Andre, Institute Gustave Roussy, Paris, France; Deborah E. Collyar, Patient Advocates in Research; Elizabeth H. Hammond, University of Utah and Intermountain Health Care, Salt Lake City, UT; Ana M. Gonzalez-Angulo and Robert C. Bast, The University of Texas MD Anderson Cancer Center, Houston; Robert G.Mennel, Baylor University Medical Center and Texas Oncology PA, Dallas, TX; Nicole M. Kuderer, University of Washington Medical Center, Seattle, WA; Minetta C. Liu, Mayo Clinic College of Medicine, Rochester, MN; and Catherine Van Poznak and Daniel F. Hayes, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI.
authors: Daniel F
authors: DF
authors: Hayes
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D014408:Biomarkers, Tumor / Q000032:analysis*; D001943:Breast Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018270:Carcinoma, Ductal, Breast / Q000737:chemistry / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D000066491:Clinical Decision-Making / Q000379:methods*; D015897:Comorbidity; D018572:Disease-Free Survival; D019317:Evidence-Based Medicine; D005260:Female; D006801:Humans; D009367:Neoplasm Staging; D017395:Plasminogen Activator Inhibitor 1 / Q000032:analysis; D011237:Predictive Value of Tests; D016032:Randomized Controlled Trials as Topic; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis*; D011960:Receptors, Estrogen / Q000032:analysis*; D011980:Receptors, Progesterone / Q000032:analysis*; D015203:Reproducibility of Results; D016019:Survival Analysis; D014568:Urokinase-Type Plasminogen Activator / Q000032:analysis
chemical_list: D000970:Antineoplastic Agents; D018931:Antineoplastic Agents, Hormonal; D014408:Biomarkers, Tumor; D017395:Plasminogen Activator Inhibitor 1; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D014568:Urokinase-Type Plasminogen Activator; C051321:SERPINE1 protein, human; C508053:ERBB2 protein, human