Abstract
3555 Background: BV (Avastin™) is a monoclonal antibody to VEGF; in the pivotal trial in mCRC, addition of BV to first-line irinotecan, 5-fluorouracil and leucovorin (IFL) significantly prolonged progression-free survival (PFS) and overall survival (OS). pl-VEGF has been shown to be prognostic in mCRC. We developed a highly sensitive pl-VEGF enzyme-linked immunosorbent assay (ELISA) to correlate pretreatment pl-VEGF concentration with PFS and OS for both overall prognosis and prediction of response to BV. Methods: In the pivotal trial, pretreatment pl-VEGF samples were collected in the first 398 pts randomized to IFL plus either BV or placebo; 384 pts (193 BV, 191 placebo) consented for non-pharmacokinetic studies of these samples. Citrated pl-VEGF was measured by an indirect ELISA with upper and lower limits of quantitation of 889 and 12.5 pg/mL, respectively, and treated as a continuous variable in these analyses. Median OS and PFS were estimated from Kaplan-Meier curves and hazard ratios (HRs) by Cox r...
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