Adjuvant immunotherapy in patients with resected gastric and oesophagogastric junction cancer following preoperative chemotherapy with high risk for recurrence (ypN+ and/or R1): European Organisation of Research and Treatment of Cancer (EORTC) 1707 VESTIGE study

作者：Florian Lordick, M. Mauer, Gertraud Stocker, C.A. Cella, Irit Ben‐Aharon, Guillaume Piessen, L. Wyrwicz, Ghazwan Al-Haidari, Tania Fleitas, Valérie Boige, Radka Obermannová, Ute Martens, Carlos Gómez-Martín, Peter Thuss‐Patience, Virginia Arrazubi, Antonio Avallone, Kai‐Keen Shiu, P Artru, Baruch Brenner, C. Bugés Sánchez, Ian Chau, Sylvie Lorenzen, S Daum, Marianne Sinn, Barbara Merelli, Nicole C.T. van Grieken, Magnus Nilsson, Maike Collienne, A. Giraut, Elizabeth Smyth · 发表于：Annals of Oncology · 年份：2024 · DOI：10.1016/j.annonc.2024.10.829 · 被引用次数：58 · 研究领域：Esophageal Cancer Research and Treatment、Cancer Immunotherapy and Biomarkers、Gastric Cancer Management and Outcomes

BACKGROUND: Patients with gastro-oesophageal adenocarcinoma with tumour-positive lymph nodes (ypN+) or positive surgical margins (R1) following neoadjuvant chemotherapy and resection are at high risk of recurrence. Adjuvant nivolumab is effective in oesophageal/oesophagogastric junction cancer and residual pathological disease following chemoradiation and surgery. Immune checkpoint inhibition has shown efficacy in advanced gastro-oesophageal cancer. We hypothesised that nivolumab/ipilimumab would be more effective than adjuvant chemotherapy in high-risk (ypN+ and/or R1) patients with gastro-oesophageal adenocarcinoma following neoadjuvant chemotherapy and resection. PATIENTS AND METHODS: VESTIGE was an academic international, multicentre, open-label, randomised phase II trial evaluating the efficacy of adjuvant nivolumab/ipilimumab versus chemotherapy in gastro-oesophageal adenocarcinoma at high risk of recurrence. Patients were randomised 1 : 1 to receive standard adjuvant chemotherapy (same regimen as neoadjuvant) or nivolumab 3 mg/kg intravenously (i.v.) every 2 weeks plus ipilimumab 1 mg/kg i.v. every 6 weeks for 1 year. Key inclusion criteria included ypN+ and/or R1 status after neoadjuvant chemotherapy plus surgery. The primary endpoint was disease-free survival in the intent-to-treat population. Secondary endpoints included overall survival, locoregional and distant failure rates, and safety according to National Cancer Institute Common Terminology Criteria for Adverse...