Methods for predicting clinical outcome for inhibitors of epidermal growth factor receptor for cancer patients

摘要

A process for obtaining a score of expression correlated with an increased copy number of the EGFR gene predicts response of a person to therapy EGFR inhibitor, a tissue specimen obtained from a person who has or is suspected of having cancer comprising: a) determining by immunohistochemistry score fraction, where the score fraction is the percentage of cells in the tissue specimen which have positive staining for a score of EGFR protein and is expressed as a number between 0 and 100 corresponding to the percentage of cells in the sample of tumor cells having positive staining for protein between 0% and 100%; b) determining an intensity score corresponding to the intensity of staining of the biomarker in the sample of tumor cells and expressed in a number of at least 1 and no more than 4 corresponding to the staining intensity of the protein in the sample tumor cells; c) calculating a score that is the expression product fraction score and intensity score and expressed as an integer between 0 and 400; d) select the individual as predestined to respond to the therapeutic administration of an EGFR inhibitor, if the expression score is equal to or greater than 200; e) select the person as not predestined to respond to the therapeutic administration of an EGFR inhibitor, if the score is less than 200 expression.