N0147

Regimen

Experimental
mFOLFOX6 + cetuximab
Control
mFOLFOX6 alone

Population

Stage III colon cancer after curative resection (N=2,686); KRAS status determined; primary analysis in KRAS wild-type patients (n=1,863), adjuvant anti-EGFR plus chemotherapy.

Key finding

NEGATIVE: 3-year DFS KRAS-WT: mFOLFOX6 74.6% vs mFOLFOX6+cetuximab 71.5% (HR 1.21, P=.08); numerically worse with cetuximab. Grade ≥3 AEs 52.3% vs 72.5% (P<.001). No benefit even in KRAS wild-type. Anti-EGFR adjuvant strategy abandoned.

Source: PMID 22474202

Timeline

    Guideline citations

    • NCCN Colon (p.103)
    • NCCN Rectal (p.159)