Safety and efficacy of everolimus (E), bevacizumab (B), and docetaxel (D) for castration resistant prostate cancer (CRPC).

Abstract

5066 Safety and efficacy of Everolimus (E), bevacizumab (B), and docetaxel (D) for castration resistant prostate cancer (CRPC) Background: Based on studies suggesting co-targeting mTOR and angiogenic pathways potentiates chemotherapy, we studied combining mTOR (E, formerly RAD001) and VEGF (B) inhibition with D in CRPC. Methods: Eligible patients (pts) had progressive, metastatic, chemo-naive CRPC. D+B was given IV day 1 with E PO daily on a 21 d cycle at level 1 (D 75 mg/m2, E 2.5 mg), level 2 (D 75 mg/m2, E 5 mg), or level 3 (D 65 mg/m2, E 5 mg). B 15 mg/kg was given at all levels. B/E without D (B/E-D) was allowed after ≥ 6 cycles. Prophylactic growth factor support was allowed only after cycle 1, if required The primary endpoint was response, defined as maximal confirmed PSA decline and RECIST criteria. Results: Dose level 1 was identified as the recommended phase 2 dose (Gross et al, 2009) thus 37 of 43 patients received level 1 dosing. Median age was 65 (50-79) years, PSA 76.6 (0-1847) ng/mL, alkali...