Efficacy findings from a randomized phase III trial of capecitabine plus oxaliplatin versus bolus 5-FU/LV for stage III colon cancer (NO16968): Impact of age on disease-free survival (DFS).

3521 Background: Adjuvant capecitabine is at least equivalent to bolus i.v. 5-FU/LV for DFS and overall survival (OS) in stage III colon cancer. NO16968 compared XELOX with bolus i.v. 5-FU/LV (standard regimen at study start) for stage III colon cancer. In a planned safety analysis, XELOX had an acceptable safety profile (Schmoll et al. JCO 2007). In a recent analysis of the ACCENT database, investigators concluded that newer adjuvant regimens are not associated with significant efficacy benefits vs. 5-FU/LV in patients (pts) ≥70 years (McCleary et al. ASCO 2009). We examined DFS across age groups in NO16968 to determine XELOX efficacy in pts ≥70 years. Methods: Pts were randomized to either XELOX (capecitabine 1,000 mg/m2 bid d1–14 + oxaliplatin 130 mg/m2 i.v. d1, q3w ×8) or bolus i.v. 5-FU/LV regimens: Mayo Clinic (LV 20 mg/m2 + 5-FU 425 mg/m2 d1–5, q4w ×6) or Roswell Park (LV 500 mg/m2 + 5-FU 500 mg/m2 d1, w1–6 in 8w cycles × 4). Results: 1,886 pts were randomized between April 2003 and October 2004. 1...