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- W1815529086 abstract "A229 The rapid growth of molecularly targeted therapy for many types of cancer has sparked a revolution in the management of patients with advanced cancer. As the dissemination of new compounds with activity in different cancers continues to provide new tools for use in the clinic, we find ourselves in the unique position of having too many drugs to choose from and no rational biological way to choose agents or combinations or to define the activity of new compounds. Renal cell carcinoma is a classic example, with 4 FDA approved compounds (interleukin-2, sorafenib, sunitinib, and temsirolimus), available agents with evidence of activity (interferon and bevacizumab), and a deep pipeline of agents in clinical development. Conventional phase II clinical trials to evaluate superior activity of one drug over another or combinations of agents are difficult to interpret, and unfortunately the development of mouse models which accurately represent the human disease do not exist at this time for directly extrapolating activity from in vivo models. At our institution we have embarked on a program to develop targeted agent evaluation through the use of neoadjuvant studies. The introduction of agents prior to definitive surgical resection provides several advantages over phase I or II studies in patients with often heavily pretreated metastatic disease. First, serum, urine, and tissue biomarker studies are untainted by the influences of prior therapy or the effects of widespread disease and declining performance status. Second, tissue availability is consistently a problem in studies performed in the setting of metastatic disease, whereas the tissue from a definitive surgical procedure is plentiful and accessible. Third, and finally, this approach permits rapid assessment of activity, evaluated by radiographic and histologic changes in the tumor over a relatively short period of time. We will present our preliminary results from a neoadjuvant study evaluating the activity of sorafenib in renal cell carcinoma." @default.
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- W1815529086 date "2007-11-01" @default.
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- W1815529086 title "Neoadjuvant clinical trials for biomarker discovery: An old idea to solve a new problem" @default.
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