Phase II trial of @entity1206 and XXXX in the treatment of metastatic @entity263 .

@entity1 @entity12749 @entity137 @entity263 @entity417 @entity882 @entity16 @entity1295 @entity344 @entity1206 @entity1150 @entity299 @entity3028 @entity204 @entity1486
The purpose of this study was to investigate the efficacy and safety of combination chemotherapy using @entity12749 and @entity1206 in chemotherapy-na  ve @entity1 with @entity263 ( @entity263 ). The @entity1 (n = 54) received oral @entity12749 840 mg/day on Days 1 to 14 and IV @entity1206 25 mg/m(2) on Days 1 and 8 of every 3 wk cycle. The median number of cycles per @entity1 was 9 (range, 1 to 27). Fifty-three @entity1 were evaluable for @entity137 and survival and 52 for @entity1486 (PSA) response. Median age was 68 (range, 46-80). PSA sustained decrease >50% was seen in 52% of @entity1 (95% CI: 38-66%). A complete response was seen in 3 and a partial response in 12 of 25 @entity1 with measurable disease, for an overall objective response of 60% (95% CI: 41-79%). Improvement in performance status was observed in 30 out of 43 evaluable for clinical benefit response. The median duration of response was 7 mo and median time to progression was 6 mo. The median survival time was 15 mo. The most common adverse event was mild @entity344 . In general, @entity137 G3-4 was low: @entity3028 Grade 3-4 (8%), @entity882 Grade 3 (6%), and @entity417 Grade 3 (13%). Other Grade 3 @entity137 included @entity1150 (4%), hepatic (2%), @entity299 (2%), @entity1295 (6%), and @entity16 (2%). There were 2 treatment-related @entity204 (4%). We conclude that @entity1206 and @entity12749 as used in this trial is an efficacious and well-tolerated therapeutic regimen in the management of @entity263 .
