Abstract
5104 Background: The increasing use of targeted therapies in metastatic renal cell carcinoma (mRCC) has raised questions about the timing of cytoreductive nephrectomy. We initiated a phase II trial to evaluate the safety and efficacy of presurgical bevacizumab (bev) in newly diagnosed patients (pts) with mRCC, with the hope of improving clinical outcomes and to obtain tissue for correlative studies. Methods: Pts with conventional-type mRCC with PS 0/1, resectable primary tumor and no brain metastasis received bev 10 mg/kg iv q2wks (plus erlotinib 150 mg daily for the first 25 pts) for 8 wks, followed 4 weeks later by cytoreductive nephrectomy. Primary endpoints: progression free survival (PFS) and safety. Secondary endpoints: response rate (RR), overall survival (OS) and correlative studies. Responding or stable pts resumed bev 4 weeks postoperatively. Response was defined by RECIST. PFS was measured from registration to date of progressive disease (PD) or death from any cause. Overall survival (OS) was m...
Published Version
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