 - Association with a significant underlying disease that may complicate response to treatment. An underlying disease is considered significant if it includes any of the following conditions that are present at the time of presentation: cancer except basal- or squamous-cell cancer of the skin, cardiac i.e., congestive heart disease, diabetes mellitus, hepatic i.e., cirrhosis or another form of chronic liver disease, immunologic, renal disease, respiratory, transplantation or vascular disease 