UNASSIGNED: 13 Background: @entity1205 / @entity229 is standard first-line chemotherapy for mCRPC. Aflibercept (known as ziv-aflibercept in the US) is a recombinant @entity1 fusion protein that binds @entity7 , @entity23877 and @entity7309 ( @entity7309 ), thereby inhibiting angiogenesis. METHODS: VENICE was a double-blind, randomized phase III study with @entity1349 ( @entity1349 ) as primary endpoint. @entity1 with mCRPC, ECOG PS 0-2, adequate organ function and no prior cytotoxic therapy were treated with @entity1205 (75 mg/m   iv q3w) and oral @entity229 (5mg bid) and randomized double blind 1:1 to receive aflibercept (A) 6 mg/kg or placebo (Pbo), IV every 3 weeks. Pts were stratified by ECOG PS (0-1 vs 2). For final @entity1349 analysis, 873 @entity204 were required to detect a hazard ratio (HR) of 0.8 with 90% power (overall 2-sided a = 0.05). RESULTS: From Aug 2007 to Feb 2010, 1224 @entity1 (median age 68 yr, PS 0-1 96%) were randomized. Baseline characteristics were well balanced between arms. Median number of cycles was 8 (A) and 9 (Pbo). Median relative dose intensity was >0.93 for A, Pbo and @entity1205 . At final cut-off, median follow-up was 35.4 mos and 873 pts had died. Results for primary and key secondary endpoints with confidence intervals are in the table. Higher incidence of all grade @entity101 , @entity3136 , @entity1277 , @entity294 , @entity2700 , @entity1415 , @entity7364 , cough, @entity10 and @entity281 was observed in the aflibercept arm. CONCLUSIONS: Aflibercept in combination with @entity1205 / @entity229 given as first line chemotherapy for mCRPC did not lead to a statistically significant improvement in @entity1349 and added @entity137 . (NCT00519285 sponsored by Sanofi and Regeneron Pharmaceuticals, Inc.) Clinical trial information: NCT00519285. [Table: see text].

Aflibercept versus placebo in combination with @entity1205 / @entity229 for first-line treatment of XXXX with metastatic castration-resistant prostate cancer (mCRPC): Results from the multinational phase III trial (VENICE).

@entity1 :: ('9606', 'Species') :: ['human', 'patients', 'Men'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity7309 :: ('5228', 'Gene') :: ['Placental Growth Factor', 'PlGF'] @entity101 :: ('MESH:D006973', 'Disease') :: ['hypertension'] @entity3136 :: ('MESH:D013280', 'Disease') :: ['stomatitis'] @entity7 :: ('7422', 'Gene') :: ['VEGF-A'] @entity2700 :: ('MESH:D003681', 'Disease') :: ['dehydration'] @entity229 :: ('MESH:D011241', 'Chemical') :: ['prednisone'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhea'] @entity1415 :: ('MESH:D004844', 'Disease') :: ['epistaxis'] @entity7364 :: ('MESH:D055154', 'Disease') :: ['dysphonia'] @entity281 :: ('MESH:D007239', 'Disease') :: ['infections'] @entity1277 :: ('MESH:D001068', 'Disease') :: ['appetite disorders'] @entity10 :: ('MESH:D006261', 'Disease') :: ['headache'] @entity23877 :: ('7423', 'Gene') :: ['VEGF-B'] @entity1205 :: ('MESH:C067311', 'Chemical') :: ['Docetaxel', 'docetaxel'] @entity204 :: ('MESH:D003643', 'Disease') :: ['deaths'] @entity1349 :: ('MESH:D011475', 'Disease') :: ['OS', 'overall survival']
@entity1 :: (9606,Species) :: ['men']
