Tolerability of adjuvant nivolumab in esophageal or gastroesophageal junction cancer in the real world

Adjuvant nivolumab is approved for esophageal or gastroesophageal junction (E/GEJ) cancer after neoadjuvant chemoradiotherapy and resection. In the CheckMate-577 trial, grade 3-5 nivolumab-related adverse events (AEs) occurred in 5% of patients, with early discontinuation due to toxicity in 9%. Real-world data on immunotherapy-related adverse events (irAEs) are limited. A retrospective cohort study at three centers in The Netherlands assessed the cumulative incidence of irAEs with nivolumab for E/GEJ cancer in the real world. Among 142 patients who received at least one cycle of adjuvant nivolumab, with a median follow-up of 27.9 months, grade 3-5 irAEs occurred in 15%. Hepatitis (3%), pneumonitis (2%), and myocarditis (2%) were most common. Two fatal irAEs occurred (1%). Median time to first grade 3-5 irAEs was 2.0 months (IQR 0.7-6.4). Grade 3-5 irAEs led to hospitalization in 9%, required systemic corticosteroids in 11%, and resulted in clinical sequelae in 8%. No predictors for grade 3-5 irAEs were identified. Early discontinuation due to irAEs occurred in 24%. The authors conclude that severe irAEs occurred more frequently than in CheckMate -577, often required hospitalization and immunosuppression, and resulted more often in discontinuation (graphical abstract).