Determination of Clinical Utility of Tumor Markers: A Tumor Marker Utility Grading System

摘要

In the last 20 years, more than 200 papers have been published in the English literature assessing either the prognostic or predictive abilities of several different putative tumor markers. In spite of this plethora of publications, very few factors have been accepted for routine use in clinical practice. In 1995, the American Society of Clinical Oncology convened an Expert Panel to develop evidence-based practice guidelines for the use of tumor markers in breast cancer (ASCO Expert Panel 1996). This panel considered several tissue-based factors, including estrogen receptor (ER), cathepsin D, p53, HER-2/c-neu/erbB-2, and flow cytometrically determined S-phase fraction. After careful deliberation, they concluded that the data were insufficient to recommend the use of any biologically based marker to determine prognosis. Furthermore, the Panel recommended that ER could be used to reliably predict response/benefit from hormone therapy, but that no other predictive factor was sufficiently well-established to be considered for routine clinical use.