dxy

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/m 2 /day plus LV 20 mg/m 2 /day for 5 days/month, followed by 45 Gy (1.8 Gy/day) and concurrent 5-FU (200 mg/m 2 /day CI throughout RT), followed by 2 cycles of 5-FU/LV; or Arm B: 1 cycle of ECF (E 50 mg/m 2 day 1, C 60 mg/m 2 day 1, and 5-FU 200 mg/m 2 /day CI days 1-21) followed by 45 Gy (1.8 Gy/day) and concurrent 5-FU (200 mg/m 2 /day CI throughout RT), followed by 2 cycles of reduced dose of ECF (E 40 mg/m 2 day 1, C 50 mg/m 2 day 1, and 5-FU 200 mg/m 2 /day CI days 1-21). Results: Between 4/03 and 5/09, 546 pts were enrolled. There were no significant differences between arms with regard to age, sex, race, performance status, T or N stage or extent of lymphadenectomy. Treatment related deaths occurred in 8 (3%) pts on Arm A (5-FU/LV) and 1 (1%) pt on Arm B (ECF). Grade 4 toxicity: 40%, Arm A v 26%, Arm B (p0.001). Major toxicities ( gr. 3) included: neutropenia (53 v 48%), diarrhea (15 v 7%), and mucositis (15 v 7%) for Arms A and B, respectively. With 242 deaths reported, median OS was 37 months in Arm A and 38 months in Arm B (HR, 1.03; 95% CI, 0.80-1.34; p0.80). 3yr-OS was 50% in Arm A and 52% in Arm B. Median disease-free survival (DFS) was 30 months in Arm A and 28 months in Arm B (HR, 1.00; 95% CI, 0.79-1.27; p0.99). 3yr-DFS was 46% in Arm A and 47% in Arm B. Conclusions: Following curative resection of gastric or GEJ adenocarcinoma, postoperative chemoRT using ECF before and after 5-FU/RT does not improve survival when compared to bolus 5-FU/LV before and after 5-FU/RT.