A multinational, randomized phase III study of bevacizumab (Bev) with FOLFOX4 or XELOX versus FOLFOX4 alone as adjuvant treatment for colon cancer (CC): Subgroup analyses from the AVANT trial.

Abstract

3509 Background: The therapeutic impact of Bev plus either FOLFOX4 or XELOX in the adjuvant setting was evaluated in the AVANT trial. First efficacy findings were presented at ASCO GI 2011. Here we present results of subgroup analyses. Methods: Eligible pts underwent resection for resected high-risk stage II or stage III CC. Pts were randomly assigned to 1 of 3 treatment groups and stratified by geographic region and tumor stage: Arm A: FOLFOX4 w1–24; Arm B: FOLFOX4 + Bev w1–24, then Bev alone w25–48; Arm C: XELOX + Bev w1–24, then Bev alone w25–48. The primary endpoint was disease-free survival (DFS) for stage III CC; secondary endpoints included overall survival (OS) and safety. DFS/OS follow-up assessments were performed every 6m after randomization for 4y, then annually until recurrence/death. Results: 3,451 (2,867 stage III CC) pts were enrolled between Dec 2004 and Jun 2007; median age was 58–59y. Median duration of follow-up was 48m (range 0–66). Adding Bev did not prolong DFS with FOLFOX4 (HR 1.17; 95% CI 0.98–1.39) or XELOX (HR 1.07; 95% CI 0.90–1.28); the chemotherapy alone arm was favored numerically. Key subgroup findings for DFS in stage III pts are presented below (Table). Conclusions: Subgroup analysis results for DFS were consistent with those seen in the overall stage III CC population. Follow-up is ongoing for OS analysis. Subgroups FOLFOX4 n=955 FOLFOX4 + Bev n=960 XELOX + Bev n=952 n n HR (95% CI) n HR (95% CI) Gender Male Female 530 425 487 1.07 (0.85–1.35) 473 1.32 (1.01–1.71) 520 1.04 (0.83–1.31) 432 1.11 (0.84–1.47) Age, y <65 ≥65 <70 ≥70 680 275 833 122 699 1.14 (0.93–1.40) 261 1.26 (0.92–1.73) 848 1.17 (0.97–1.41) 112 1.19 (0.72–1.96) 656 1.00 (0.80–1.24) 296 1.24 (0.91–1.69) 819 1.04 (0.86–1.26) 133 1.28 (0.80–2.06) Race Asian Black White Other 139 6 791 18 115 2.18 (1.29–3.67) 13 0.48 (0.08–2.89) 813 1.09 (0.90–1.32) 18 0.97 (0.31–3.02) 123 1.52 (0.88–2.63) 14 0.27 (0.04–1.97) 795 1.04 (0.86–1.26) 20 1.24 (0.40–3.84) No. of lymph nodes analyzed <12 ≥12 269 684 261 1.26 (0.91–1.75) 695 1.13 (0.92–1.39) 275 1.06 (0.76–1.49) 675 1.08 (0.88–1.34) N stage N1 N2 585 370 590 1.37 (1.07–1.76) 370 0.99 (0.78–1.26) 572 1.14 (0.87–1.48) 380 0.99 (0.78–1.26)