assays for monitoring of cancer patients based on the levels of the analytes in the extracellular domain (ecd) of the epidermal growth factor receptor (egfr)alone or in combination with other analytes in samples of body fluids

摘要

The present invention describes clinically and medically important methods of monitoring the outcome of a cancer patient who is suffering from disease or who is undergoing treatment or therapy for his or her disease. More specifically, the invention provides a method of monitoring the progression of disease or cancer treatment effectiveness in a cancer patient by measuring the level of the extracellular domain (ECD) of the epidermal growth factor receptor (EGFR) in a sample taken from the cancer patient, preferably, before treatment, at the start of treatment, and at various time intervals during treatment, wherein a decrease in the level of the ECD of the EGFR in the cancer patient compared with the level of the ECD of the EGFR in normal control individuals serves as an indicator of cancer advancement or progression and/or a lack of treatment effectiveness for the patient. As another aspect of determining disease outcome and survival, the invention further provides assessing both EGFR and HER-2/neu levels, in combination, in a patient sample. A finding of decreased levels of EGFR concomitantly with elevated or increased levels of HER-2/neu relative to control levels indicates poor outcome and short time to progression.