Study
| Phase 3, multicenter, randomized, controlled trial (ESOPEC) |
| Esophageal or GE junction adenoCa, cT1cN+, cT2–4a cN+, or cT2–4a cN0 |
| FLOT (perioperative chemotherapy) vs. preoperative chemoradiotherapy |
Efficacy
| 3-yr OS: 57.4% vs. 50.7% (FLOT vs. preoperative chemoradiotherapy) (HR: 0.70 [0.53-0.92]) |
| 5-yr OS: 50.6% vs. 38.7% |
| mOS: 66 mos (95% CI, 36 to NE) vs. 37 mos (95% CI, 28 to 43) |
| 3-yr PFS: 51.6% vs. 35.0% (HR: 0.66 [0.51-0.85]) |
| Pathological CR (ypT0 ypN0): 16.7% vs. 10.1% |
Safety
| Grade ≥3 AEs: Neutropenia (19.8% vs. NA), diarrhea (6.8% vs. NA), leukopenia (6.3% vs. 9.7%), pneumonia (5.8% vs. 9.2%) |
| Serious AEs: 47.3% vs. 41.8% |
| Treatment-related 90-day mortality: 3.1% vs. 5.6% |
N Engl J Med 2025;392:323-335
http://doi.org/10.1056/NEJMoa2409408
Reviewed by Ulas D. Bayraktar, MD on Jan 24, 2025
