Study
Multicenter, randomized, noncomparative phase 2 trial (PANACHE01 FRENCH08 PRODIGE48) |
Resectable pancreatic adenocarcinoma patients |
Neoadjuvant mFOLFIRINOX (4 cycles) vs. neoadjuvant FOLFOX (4 cycles) vs. up-front surgery |
Efficacy
1-yr OS: 84.3% vs. 71.4% vs. 82.1% (mFOLFIRINOX vs. FOLFOX vs. up-front surgery) |
mOS: 31.3 mos vs. 31.8 mos vs. NR (95% CI: 21.5–NE vs. 23.8–NE vs. 18.5–NE) |
mEFS: 12.4 mos vs. 11.0 mos vs. 6.8 mos (95% CI: 9.1–15.6 vs. 4.0–20.0 vs. 1.6–16.1) |
1-yr EFS: 51.4% vs. 43.1% vs. 38.7% |
Safety
Grade ≥3 AEs: Hematologic toxicity (25.8% vs. 13.3%), fatigue (6% vs. 4.4%), peripheral neuropathy (4% vs. 0%) |
Febrile neutropenia: 4.5% vs. 0% |
Postoperative complications: 74.8% of patients, with 20.4% severe complications, including 1 death |
J Clin Oncol. Accepted Feb 12, 2025
http://doi.org/10.1200/JCO-24-01378
Reviewed by Ulas D. Bayraktar, MD on Apr 7, 2025