@entity416 plus @entity901 compared with XXXX and @entity4181 as adjuvant therapy for @entity5 .

@entity901 @entity1 @entity4181 @entity416 @entity5 @entity694 @entity1487
PURPOSE: This multicenter, randomized trial compared @entity416 plus @entity901 (XELOX) with bolus @entity1487 (FU) and @entity4181 (FA) as adjuvant therapy for @entity1 with @entity5 . @entity1 AND METHODS: @entity1 who had undergone curative resection were randomly assigned to XELOX ( @entity901 130 mg/m(2) on day 1 plus @entity416 1,000 mg/m(2) twice daily on days 1 to 14 every 3 weeks for 24 weeks) or a standard bolus FU/FA adjuvant regimen (Mayo Clinic for 24 weeks or Roswell Park for 32 weeks). The primary study end point was disease-free survival (DFS). RESULTS: The intention-to-treat population comprised 1,886 @entity1 ; 944 @entity1 were randomly assigned to XELOX and 942 to FU/FA (Mayo Clinic, n = 664; Roswell Park, n = 278). After 57 months of follow-up for the primary analysis, 295 @entity1 (31.3%) in the XELOX group had relapsed, developed a new primary @entity694 , or died compared with 353 @entity1 (37.5%) in the FU/FA group (hazard ratio [HR] for DFS, 0.80; 95% CI, 0.69 to 0.93; P = .0045). The 3-year DFS rate was 70.9% with XELOX and 66.5% with FU/FA. The HR for overall survival (OS) for XELOX compared to FU/FA was 0.87 (95% CI, 0.72 to 1.05; P = .1486). The 5-year OS for XELOX and FU/FA were 77.6% and 74.2%, respectively. Follow-up is ongoing. Preplanned multivariate and subgroup analyses supported the robustness of these findings. CONCLUSION: The addition of @entity901 to @entity416 improves DFS in @entity1 with @entity5 . XELOX is an additional adjuvant treatment option for these @entity1 .
