Abstract
5115 Background: DMXAA (AS1404) is a small-molecule agent that disrupts tumor vasculature. Combination of DMXAA with taxanes produces synergistic inhibition of tumor growth in animal models. A randomized phase II study in non-small cell lung cancer reported a substantial survival benefit when DMXAA was added to paclitaxel-based chemotherapy. This randomized phase II study examined the effect of adding DMXAA to docetaxel in HRMPC. Methods: Patients had progressive metastatic, androgen-independent, histologically confirmed prostate adenocarcinoma previously untreated with cytotoxics. Patients were randomized 1:1 to receive docetaxel (75 mg/m2) ± DMXAA (1,200 mg/m2) every 21 days for up to 10 cycles. Efficacy endpoints were prostate-specific antigen (PSA) response rate, objective response rate, time to tumor progression, duration of response and disease stabilization, time to PSA progression, and median and 1-year survival. Results: 74 patients were randomized: 34 to DMXAA plus docetaxel (DMXAA arm) and 40 to docetaxel alone (control arm). Median baseline PSA values were 83 ng/ml (range 6–3574 ng/ml) in the DMXAA arm and 87 ng/ml (range 1–570 ng/ml) in the control arm. PSA response data are available from 64 patients (see table ). Latest safety data show a similar number of serious adverse events reported across the treatment groups with 15 and 19 in the DMXAA and control arms, respectively. Conclusions: Addition of DMXAA to standard-dose docetaxel was well tolerated and the combination produced a substantially higher PSA response rate than docetaxel alone. DMXAA demonstrates promising activity in this patient population. [Table: see text] [Table: see text]
Published Version
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