Breast cancer is the most common cancer in women, and current screening approaches have resulted in earlier diagnosis. Although over half of women diagnosed with breast cancer have disease localized to the primary site [61%: Surveillance, Epidemiology, and End Results (SEER) 18 2005–2011, All Races, Females by SEER Summary Stage 2000], approximately 10–15% of patients with node-negative breast cancer will ultimately suffer recurrent or metastatic disease. One of the major scientific crusades in oncology has been to identify and validate biomarkers associated with recurrent disease to select patients for therapy that could prevent this morbidity and mortality.
Indeed, many biomarker assays have been described, initially through the multivariate biostatistical analysis of clinical and pathologic features of patients to identify cutoff values that are associated with differences in prognosis. These findings led David Page, one of the giants of breast pathology, to use the acronym YAPI for “yet another prognostic indicator.” With the exceptions of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor 2 (HER-2) status, the precision diagnostics of personalized medicine has replaced an earlier generation of biomarker candidates with multiple biomarker assays that have gained traction in the clinical arena.
The recommendations of the American Society of Clinical Oncology (ASCO) for use of biomarker assays to guide the decision-making process in the administration of adjuvant systemic (chemo)therapy in women with early-stage breast cancer were published very recently in the Journal of Clinical Oncology (L.N. Harris et al., “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,” J Clin Oncol 2016; Feb 8, pii: JCO652289. [Epub ahead of print] PMID: 26858339).
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