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The following is a summary of “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,” published in the November 2024 issue of Oncology by Lordick et al.  

Patients with gastroesophageal adenocarcinoma who have tumor-positive lymph nodes (ypN+) or positive surgical margins (R1) after neoadjuvant chemotherapy and surgery are at high risk for recurrence. Researchers conducted a prospective study to evaluate whether nivolumab/ipilimumab improves disease-free survival in patients with high-risk gastroesophageal adenocarcinoma following neoadjuvant chemotherapy and surgery.  

They conducted the VESTIGE trial (EORTC 1707), which randomized patients in a 1:1 ratio to receive either standard chemotherapy or nivolumab at a dose of 3 mg/kg intravenously every 2 weeks, along with ipilimumab at a dose of 1 mg/kg every 6 weeks for 1 year. The primary endpoint of the trial was disease-free survival, while secondary endpoints included OS, failure rates, and safety, as assessed by the National Cancer Institute-Common Terminology Criteria for AEs version 5.0.  

The results showed that the independent Data Monitoring Committee reviewed data from 189 planned 240 patients (June 2022) and recommended stopping recruitment due to futility. At the time of final analysis, the median follow-up was 25.3 months for 195 patients (98 nivolumab/ipilimumab and 97 chemotherapy). Median disease-free survival for the nivolumab/ipilimumab group was 11.4 months (95% CI, 8.4-16.8 months) vs. 20.8 months (95% CI, 15.0-29.9 months) for the chemotherapy group, with a HR of 1.55 (95% CI, 1.07-2.25, 1-sided P=0.99). The 12-month disease-free survival rates were 47.1% and 64.0%, respectively, with no toxicity concerns or excess early discontinuations.  

They concluded that nivolumab/ipilimumab did not improve disease-free survival compared to chemotherapy in patients with high-risk gastroesophageal adenocarcinoma following neoadjuvant chemotherapy and surgery.  

Source: annalsofoncology.org/article/S0923-7534(24)04906-8/fulltext