Tolerability of Adjuvant Nivolumab in Esophageal or Gastroesophageal Junction Cancer: A Real-World Study.

Authors

Michelle Koops van 't Jagt, Anniek Strijdhorst, Tamara Jessica Huizer, Esther Albertien Kleibeuker, Sarah Derks, Bianca Mostert, Hanneke van Laarhoven, Jacco Juri de Haan

Published in

International journal of cancer. Aug 09, 2026. Epub Aug 09, 2026.

Abstract

Adjuvant nivolumab is approved for esophageal or gastroesophageal junction 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%. However, real-world data on immunotherapy-related adverse events (irAEs) are limited. This study assessed the cumulative incidence of irAEs in a real-world setting. In this retrospective cohort study, all patients receiving ≥ 1 cycle of adjuvant nivolumab at three Dutch gastroesophageal cancer centers were included. Clinical data were extracted from electronic records. The primary outcome was the cumulative incidence of Grade 3-5 irAEs. Secondary outcomes included predictors, timing, and clinical outcomes of Grade 3-5 irAEs, and cumulative incidence of Grade 2 irAEs. Among 142 patients with median follow-up 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 irAE 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 any irAE occurred in 24%. In conclusion, severe irAEs (Grade 3-5) occurred more frequently than in CheckMate-577 and often required hospitalization and immunosuppression, with sequelae in a significant proportion. Discontinuation due to irAEs was higher than in CheckMate-577 (24% vs. 9%). Careful risk-benefit assessment and active monitoring during adjuvant nivolumab therapy are warranted.

PMID:
42572384
Bibliographic data and abstract were imported from PubMed on 10 Aug 2026.

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