Evidence for Xeloda comes from two phase III trials: X-ACT and XELOXA (n=3 848) 1° endpoint: DFS Stage III, resection 8 weeks Xeloda (n=1 004) Bolus 5
{"Image DocumentName": "Bolus 5-FU/LV (Mayo Clinic or Roswell Park)", "Image ImageDescription": "Evidence for Xeloda comes from two phase III trials: X-ACT and XELOXA (n=3 848) 1\u00b0 endpoint: DFS. Xeloda. (n=1 004) X-ACT. Stage III, resection \u00a38 weeks. 24 weeks. Bolus 5-FU/LV. (n=983) 1\u00b0 endpoint: DFS. XELOX (n=937) 24 weeks. Xeloda is firmly established as first-line treatment for metastatic colorectal cancer (MCRC). In MCRC two randomized, phase III trials have demonstrated superior response rates and similar time to progression and overall survival with favorable safety for Xeloda versus bolus 5-FU/LV [1,2]. An open-label, multinational, randomized phase III trial, the Xeloda Adjuvant Chemotherapy Trial (X-ACT), evaluated Xeloda versus bolus 5-FU/LV as adjuvant treatment for stage III colon cancer [3,4]. Primary endpoint: at least equivalence with Xeloda in DFS. Secondary objectives: equivalence in relapse-free survival (RFS) and overall survival; predefined superiority and confirmatory analyses (subgroups, multivariate); safety; pharmacoeconomics. Multivariate analyses were prospectively planned to assess the robustness of the analyses for DFS, RFS and overall survival, subgroup analysis of DFS was also planned. A second phase III trial, XELOXA, is evaluating Xeloda in combination with oxaliplatin versus two bolus regimens of 5-FU/LV, the Mayo Clinic regimen and the Roswell Park regimen [5]. A total of 1886 patients with surgically resected, chemotherapy-na\u00efve, stage III colon cancer have been randomized 1:1. Patients received eight cycles of standard XELOX versus four cycles of 5-FU/LV (Roswell Park regimen; 32 weeks) or six cycles of 5-FU/LV (Mayo Clinic regimen; 24 weeks); choice of comparator regimen was preselected by each center prior to study start. The primary objective is to show that DFS is superior with XELOX versus bolus 5-FU/LV. Secondary endpoints include overall survival, tolerability, convenience and pharmacoeconomic outcomes; pharmacogenetic and tumor marker studies are also being performed. 1. Van Cutsem E et al. Br J Cancer 2004;90:1190\u20137. 2. Cassidy J et al. Ann Oncol 2002;13:566\u2013 Scheithauer W et al. Ann Oncol 2003;14:1735\u2013 Cassidy J et al. J Clin Oncol 2004;22:247s (Abstract 3509). 5. Schmoll H-J et al. J Clin Oncol Proc ASCO 2005 (Abstract 3523). Stage III colon cancer. XELOXA. Bolus 5-FU/LV (Mayo Clinic or Roswell Park) (n=924) 24 or 32 weeks.", "Image XResolution": "37", "Image YResolution": "37", "Image ResolutionUnit": "Pixels/Centimeter", "Image Software": "SlidePlayer", "Image YCbCrPositioning": "Centered"}