PRODIGE-23

Regimen

Experimental
Induction mFOLFIRINOX × 6 cycles → CRT (50.4 Gy + capecitabine) → surgery → adjuvant mFOLFOX6
Control
CRT (50.4 Gy + capecitabine) → surgery → adjuvant mFOLFOX6

Population

Locally advanced rectal cancer cT3–T4 M0 (N=461), neoadjuvant induction TNT approach.

Key finding

3-year DFS: induction FOLFIRINOX + CRT 75.7% vs CRT alone 68.5% (HR 0.69, P=0.034); pCR 27.5% vs 12.1% (OR 2.76, P<0.0001); 3-year metastasis-free survival 79.0% vs 71.7% (HR 0.64). Induction FOLFIRINOX before CRT improves all endpoints.

Source: PMID 33862000

Timeline

    Guideline citations

    • NCCN Colon (p.58)
    • NCCN Rectal (p.57)