Study
Randomized, open-label, phase II/III trial [GENERATE, JCOG1611] |
Metastatic or recurrent pancreatic cancer |
mFOLFIRINOX (n=175) vs S-IROX (n=176) vs nab-paclitaxel gemcitabine (n=176) |
Efficacy
ORR: 35.4% vs 32.4% vs 42.4% |
mOS: 17.1 mos vs 14.0 mos (HR 1.31 [0.97-1.77]) vs 13.6 mos (HR 1.35 [1.00-1.82]) |
mPFS: 6.7 mos vs 5.8 mos (HR 1.15 [0.91-1.45]) vs 6.7 mos (HR 1.07 [0.84-1.35]) |
Safety
Grade >=3 AE: neutropenia (60.3% vs 51.5% vs 38.7%), anorexia (5.2% vs 22.8% vs 27.6%), diarrhea (1.1% vs 8.8% vs 23.0%) |
Treatment-related death: 0.2% (S-IROX) |
J Clin Oncol 2025;00(0):1-10
http://doi.org/10.1200/JCO.24.00936
Reviewed by Elvin Chalabiyev, MD on Sep 3, 2025