Patent ID: 8691231

Claim:
A method for determining whether a patient having a tumor is predicted to have an unfavorable outcome as a result of treatment #1 with a monoclonal anti-EGFR antibody preparation comprising a single species of monoclonal antibody, and a favorable outcome as a result of treatment #2 with an oligoclonal anti-EGFR antibody preparation comprising a plurality of species of monoclonal anti-EGFR antibodies, one against each of at least two extracellular epitopes of EGFR, or, whether the patient is predicted to have the favorable outcome as a result of treatment #2 and as a result of treatment #1; the method comprising: obtaining a biopsy sample of the tumor and: a) measuring levels of protein of, or of RNAs coding for, at least two low affinity EGFR ligands selected from amphiregulin, epigen, or epiregulin in the biopsy sample, b) measuring levels of protein of, or of RNAs coding for, at least two high affinity EGFR ligands selected from betacellulin, EGF, HB-EGF or TGFα in the biopsy sample, wherein all of the levels measured in a) and b) are protein levels or all of the levels measured in a) and b) are RNA levels, and c) comparing the average level of protein of, or of RNAs coding for, each of the high affinity EGFR ligands measured in a) to the average level of protein of, or of RNAs coding for, each of the low affinity EGFR ligands measured in b); and wherein, if the average level of protein of, or of RNAs coding for, low affinity EGFR ligands measured in a) is greater than the average level of protein of, or of RNAs coding for, high affinity EGFR ligands measured in b), the patient is predicted to have the favorable outcome as a result of treatment #1 and the patient is also predicted to have the favorable outcome as a result of treatment #2, and if the average level of protein of, or of RNAs coding for, low affinity EGFR ligands measured in a) is less than or equal to the average level of protein of, or of RNAs coding for, high affinity EGFR ligands measured in b), the patient is predicted to have an unfavorable outcome from treatment #1 and is predicted to have a favorable outcome from treatment #2.