N9741

Regimen

Experimental
FOLFOX4 (oxaliplatin + infusional 5-FU/LV)
Control
IFL (bolus irinotecan + 5-FU/LV); IROX (irinotecan + oxaliplatin) as third arm

Population

Metastatic CRC, 1L, previously untreated; three-arm comparison establishing FOLFOX superiority over IFL.

Key finding

1L mCRC: FOLFOX vs IFL: mTTP 8.7 vs 6.9 mo (p=0.0014); ORR 45% vs 31% (p=0.002); mOS 19.5 vs 15.0 mo (p=0.0001); IROX: mTTP 6.5 mo, mOS 17.4 mo; FOLFOX significantly superior to IFL on all endpoints

Source: PMID 14665611

Timeline

    Guideline citations

    • NCCN Colon (p.114)
    • NCCN Rectal (p.133)