Medline ® Abstract for Reference 3
of 'Adjuvant chemotherapy for HER2-negative breast cancer'
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.
Harris LN, Ismaila N, McShane LM, Andre F, Collyar DE, Gonzalez-Angulo AM, Hammond EH, Kuderer NM, Liu MC, Mennel RG, Van Poznak C, Bast RC, Hayes DF, American Society of Clinical Oncology
J Clin Oncol. 2016;34(10):1134. Epub 2016 Feb 8.
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, 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.
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.
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.