Neo-AEGIS (Neoadjuvant Trial in Adenocarcinoma of the Esophagus and Esophago-Gastric Junction International Study): Final primary outcome analysis.

• DOI: 10.1200/jco.2023.41.4_suppl.295
• Publication Date: 2023-01-24T21:05:07Z
• Authors: John V. Reynolds; Shaun R. Preston; Brian O'Neill; Maeve Aine Lowery; Lene Baeksgaard; Thomas Crosby; Moya Cunningham; Sinead Cuffe; Gareth Owen Griff...; Rajarshi Roy; Stephen Falk; George Hanna; Frederick R. Bart...; Imelda Parker; Alberto Alvarez-I...; Magnus Nilsson; Guillaume Piessen; Signe Risum; Narayanasamy Ravi; Raymond S. McDermott
• Keywords: Epirubicin; Regimen; Carboplatin; Chemoradiotherapy; Chemotherapy regimen

295 Background: The optimum combination curative approach to locally advanced adenocarcinoma of the esophagus and esophago-gastric junction (AEG) remains controversial, specifically whether multimodal therapy or perioperative chemotherapy is superior. Neo-AEGIS was designed as first randomized clinical trial (RCT) directly compare CROSS regimen (carboplatin/paclitaxel, 41.4Gy radiation therapy) with a modified MAGIC (epirubicin, cisplatin (oxaliplatin), 5-FU (capecitabine)) (pre-2018) more latterly FLOT (docetaxel, 5-FU, leucovorin, oxaliplatin) regimen. Methods: 377 patients cT 2-3 N 0-3 M 0 AEG were randomly assigned peri-operative (ECF/ECX/EOF/EOX pre-2018, option 2019/20) at 24 sites (Ireland, UK, Denmark, France, Sweden). primary outcome overall survival. initial power calculation based on superiority 10%. This after futility analysis (70 events) non-inferiority margin 5% for chemotherapy. Secondary end points included toxicity, pathologic measures response, postoperative complications per Esophageal Complications Consensus Group (ECCG) definitions Clavien-Dindo severity grade. Results: Of 362 evaluable patients, 178 CROSS, 184 MAGIC/FLOT (157/27), 90% male, median (range) age 64 (35-83), 84% cT3, 58% cN1. At follow up 34.2 (0.43-111.8) months, there 186 deaths, 91 95 arm, 3-year estimated survival probability 57% (95% CI 49,64) 55% 47,62), respectively [(HR 1.03 (95%CI. 0.77-1.38))]. Conclusions: RCT reveals no evidence that unacceptably inferior in survival, notwithstanding greater proxy markers local tumor response arm. Oncologic operative outcomes consistent modern benchmarks. These data strongly suggest support equipoise decision making practice. Clinical information: NCT01726452 . [Table: see text]