@entity1311 plus @entity3003 versus @entity136 plus XXXX in advanced @entity1149 : a phase III randomized trial.

@entity1 @entity137 @entity417 @entity882 @entity3003 @entity1149 @entity1311 @entity1398 @entity136 @entity7634
PURPOSE: We conducted this randomized study comparing the activity and @entity137 of @entity1311 and @entity136 (PG) and @entity1311 and @entity3003 (PC) combinations for the treatment of advanced @entity1149 ( @entity1149 ). @entity1 AND METHODS: Chemotherapy-naive @entity1 were randomized to @entity1311 200 mg/m(2) on day 1 plus either @entity3003 at an area under the concentration-time curve of 6 on day 1 (group A) or @entity136 1,000 mg/m(2) on days 1 and 8 (group B) every 3 weeks. A retrospective cost analysis was conducted using Student's t test to compare independent samples between groups. RESULTS: A total of 509 @entity1 (group A, 252 @entity1 ; group B, 257 @entity1 ) were enrolled; all characteristics were well balanced. The median survival time was 10.4 months (95% confidence interval [CI], 8.8 to 12 months) for group A and 9.8 months (95% CI, 8.0 to 11.7 months) for group B (P =.32). Respective 1-year survival rates were 41.7% and 41.4%. The response rate for group A was 28.0% (2% complete response [CR], 26% partial response [PR] [95% CI, 22% to 34%]), and the response rate for group B was 35.0% (5% CR, 30% PR) [95% CI, 29% to 41%]) (P =.12). @entity137 was mild. Grades 3/4 @entity1398 , @entity882 , and @entity417 for groups A and B were seen in 15% and 15%, 2% and 1%, and 5% and 2%, respectively. The mean total cost (outpatient clinic visits plus chemotherapy drug fee) for group A ( @entity7634 ; 7,612.64) versus group B ( @entity7634 ; 7,484.77) was not statistically significant (P <.66). CONCLUSION: The PG combination is as equally active and well tolerated as the PC combination in @entity1 with advanced @entity1149 .
