Monoclonal and oligoclonal anti-egfr antibodies for use in the treatment of tumors expressing predominantly high affinity egfr ligands or tumors expressing predominantly low affinity egfr ligands

Abstract

Disclosed are pharmaceutical preparations for, and methods for determining, appropriate and effective treatment with therapeutic agents comprising a single species of anti-EGFR monoclonal antibody or therapeutic agents comprising a plurality of species of such antibodies, as well as kits useful for making such determinations.

What is claimed is: 
     
         1 . A method for determining whether or not matuzumab should be used to treat a malignant tumor, the method comprising: obtaining a biopsy sample of the tumor and: a) measuring levels of at least two of amphiregulin, epigen, or epiregulin in the biopsy sample, b) measuring levels of at least two of betacellulin, EGF, HB-EGF or TGFα in the biopsy sample, and c) comparing the average level measured in a) to the average level measured in b); wherein, if the average level measured in a) is greater than the average level measured in b), matuzumab should be used to treat the tumor, and if the average level measured in a) is less than or equal to the average level measured in b), matuzumab should not be used to treat the tumor. 
     
     
         2 . A method for determining whether or not matuzumab should be used to treat a malignant tumor, the method comprising: obtaining a biopsy sample of the tumor and: a) measuring levels of RNAs coding for at least two of amphiregulin, epigen, or epiregulin in the biopsy sample, b) measuring levels of RNAs coding for at least two of betacellulin, EGF, HB-EGF or TGFα in the biopsy sample, and c) comparing the average level measured in a) to the average level measured in b); wherein, if the average level measured in a) is greater than the average level measured in b), matuzumab should be used to treat the tumor, and if the average level measured in a) is less than or equal to the average level measured in b), matuzumab should not be used to treat the tumor. 
     
     
         3 . The method of  claim 1 , wherein the tumor is a tumor of the skin, central nervous system, head, neck, esophagus, stomach, colon, rectum, anus, liver, pancreas, bile duct, gallbladder, lung, breast, ovary, uterus, cervix, vagina, testis, germ cells, prostate, kidney, ureter, urinary bladder, adrenal, pituitary, thyroid, bone, muscle or connective tissue. 
     
     
         4 . The method of  claim 2 , wherein the tumor is a tumor of the skin, central nervous system, head, neck, esophagus, stomach, colon, rectum, anus, liver, pancreas, bile duct, gallbladder, lung, breast, ovary, uterus, cervix, vagina, testis, germ cells, prostate, kidney, ureter, urinary bladder, adrenal, pituitary, thyroid, bone, muscle or connective tissue.