Study
Phase 3, open-label, multicenter randomized trial (PRODIGE 51- FFCD-GASTFOX) |
Pts with previously untreated advanced HER2-negative gastric/GEJ adenocarcinoma |
TFOX (docetaxel + oxaliplatin + leucovorin + 5-FU) vs. FOLFOX |
Efficacy
ORR: 62.3% vs. 53.4% (TFOX vs. FOLFOX) |
CR: 6% vs. 6% |
mPFS: 7.6 mos vs. 6.0 mos (p = 0.007) |
mOS: 15.1 mos vs. 12.7 mos |
Safety
Grade ≥3 AEs: neutropenia (27% vs. 18%), diarrhea (15% vs. 7%), neuropathy (32% vs. 20%) |
Lancet Oncol 2025; published online Apr 23
http://doi.org/10.1016/S1470-2045(24)00545-1
Reviewed by Ulas D. Bayraktar, MD on May 5, 2025