Postoperative adjuvant chemoradiation for gastric or gastroesophageal junction (GEJ) adenocarcinoma using epirubicin, cisplatin, and infusional (CI) 5-FU (ECF) before and after CI 5-FU and radiotherapy (CRT) compared with bolus 5-FU/LV before and after CRT: Intergroup trial CALGB 80101.

4003 Background: Following curative resection of gastric or GEJ adenocarcinoma, INT-0116 demonstrated superior survival for pts who received postoperative bolus 5-FU and leucovorin (LV) before and after concomitant 5-FU and RT compared to surgery alone. We assessed whether a postoperative chemoRT regimen that replaces 5-FU/LV with a potentially more active systemic therapy (ECF) improves overall survival (OS). Methods: Patients with resected gastric or GEJ adenocarcinoma were randomly assigned to either: Arm A: 1 cycle of 5-FU 425 mg/m2/day plus LV20 mg/m2/day for 5 days/month, followed by 45 Gy (1.8 Gy/day) and concurrent 5-FU (200 mg/m2/day CI throughout RT), followed by 2 cyclesof 5-FU/LV; or Arm B: 1 cycle of ECF (E 50 mg/m2 day 1, C 60 mg/m2 day 1, and 5-FU 200 mg/m2/day CI days 1-21) followed by 45 Gy (1.8 Gy/day) and concurrent 5-FU (200 mg/m2/day CI throughout RT), followed by 2 cycles of reduced dose of ECF (E 40 mg/m2 day 1, C 50 mg/m2 day 1, and 5-FU 200 mg/m2/day CI days 1-21). Results: Betwee...