ASCO releases new guideline for breast tumor biomarker tests

February 8, 2016 – ALEXANDRIA. The American Society of Clinical Oncology (ASCO) has issued a new clinical practice guideline for women with early-stage invasive breast cancer and known hormone receptor and human epidermal growth factor 2 (HER2) receptor status. The guideline includes evidence-based recommendations on the appropriate use of breast tumor biomarker tests to guide decisions on adjuvant systemic therapy. 

“In the era of precision medicine, the role of biomarkers in guiding clinical care is greater than in the past. An extensive number of new tests have come out in the last 5-10 years, but not all have sufficient evidence of clinical utility,” said Lyndsay N. Harris, MD, co-chair of the ASCO expert panel that developed the guideline. “These latest recommendations truly inform physicians about which tests need to be performed. But this is not all that goes into patient care ? doctors need to continue discussions with patients to develop individualized treatment plans.” 

The guideline recommendations were developed by a multidisciplinary expert panel, with expertise in medical oncology, radiation oncology, community oncology, statistics, and health outcome researchers. In addition, a cancer survivor was included to provide a patient perspective. The panel conducted a systematic review of literature published from January 2006 through September 2015 and identified 50 relevant studies. 

Key guideline recommendations:

The following biomarker tests may be used to guide decisions on adjuvant systemic therapy for certain patients with breast cancer: estrogen receptor, progesterone receptor, HER2 receptor, Oncotype DX, EndoPredict, PAM50, Breast Cancer Index, and urokinase plasminogen activator and plasminogen activator inhibitor type 1. No biomarker test, except for estrogen receptor, progesterone receptor, and HER2 receptor should be used to guide choices of specific drugs or treatment regimens.  Treatment decisions should also consider disease stage, comorbidities and patient preferences.

The guideline, Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women with Early-Stage Invasive Breast Cancer: American Society of Clinical Practice Guideline, was published today in the Journal of Clinical Oncology

The guideline will be available at, along with supplementary materials.

Source: ASCO