OPUS

NCT00113763 📎

Regimen

Experimental
Cetuximab + FOLFOX4
Control
FOLFOX4 alone

Population

Metastatic CRC, 1L; primary analysis in all-comers, key subgroup in KRAS wild-type patients.

Key finding

1L mCRC (all-comer): primary endpoint ORR cetuximab+FOLFOX4 46% vs FOLFOX4 36% (p=0.064, not significant); KRAS-wt subgroup: ORR 61% vs 37% (p=0.011); mPFS 7.7 vs 7.2 mo (HR 0.57, p=0.0163) favoring cetuximab; KRAS-mut: ORR trend against cetuximab (33% vs 49%)

Source: PMID 19114683

Timeline

    Guideline citations

    • NCCN Colon (p.35)
    • NCCN Rectal (p.46)