ESOPEC

Is perioperative FLOT superior to CROSS chemoradiotherapy for resectable esophageal adenocarcinoma?

Population and treatment

438 randomized: 221 FLOT, 217 CROSS.

Intervention vs comparator: Perioperative FLOT vs preoperative carboplatin/paclitaxel with 41.4 Gy RT then surgery.

Registry: https://pubmed.ncbi.nlm.nih.gov/?term=ESOPEC+FLOT+CROSS+NEJM

Results

3-year OS 57.4% vs 50.7%; HR 0.70 (95% CI 0.53–0.92; p=0.01). 3-year PFS 51.6% vs 35.0%; HR 0.66 (95% CI 0.51–0.85). Grade ≥3 AEs 58% vs 50%; 90-day postoperative mortality 3.1% vs 5.6%.

Overall survival · 3 years

NNT: NCT02509286

NNH not calculated without a defensible fixed-time excess-harm risk. Never derive NNT from median survival or HR alone.

Toxicity and treatment burden

50.7

Full grade 3–5 toxicity, discontinuation, QoL and treatment exposure require primary-report/supplement extraction before full clinical signoff. Missing rates are not imputed.

Interpretation and limitations

Direct randomized comparison against CROSS. Approximate NNT 15 at 3 years; balance OS against grade ≥3 toxicity and treatment completion.

Distinguish prespecified from exploratory subgroups, mature from immature endpoints, and superiority from non-inferiority. Verify current guidelines and eligibility.

Primary source

Primary publication / authoritative source ↗

Source-level QoL, discontinuation, full toxicity and guideline currency audit remains a QC requirement.