The risk of treatment-related adverse events (TRAEs) in advanced gastric or gastroesophageal junction cancer (AG/GEJC) with immunotherapy has not adequately assessed, and it remains uncertain whether there is an increased risk of TRAEs owing to immune checkpoint inhibitors (ICIs).
Immunotherapy did not have a significantly increased risk experiencing any type of TRAEs.
ICIs had a more manageable safety profile than chemotherapy.
CTLA-4 inhibitors were associated with higher risk of TRAEs compared PD-1/PD-L1 inhibitors.
Immune checkpoint inhibitors (ICIs) have been recognized as an effective treatment for advanced gastric or gastroesophageal junction cancer (AG/GEJC). However, the safety of ICIs in patients has not been established. We aimed to systematically assess the risk of all common treatment-related adverse events (TRAEs) in immunotherapy of AG/GEJC.
A systematic search of randomized controlled trials (RCTs) published until May 2022 was performed using PubMed, Embase, Web of Science, and the Cochrane Central Register of Controlled Trials. And a meta‐analysis was performed according to the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses (PRISMA) statement.
A total of nine RCTs, including 2918 patients, met the eligibility criteria. The pooled overall incidences of all grade TRAEs, grade 3 or higher TRAEs and treatment-related death were 54.5% (95% confidence interval [CI]: 48.7%–60.2%, I2=75.55%), 12.8% (95% CI: 10.2%–15.7%, I2=51.61%) and 0.11% (95% CI: 0.00%–0.51%, I2=1.63%). Subgroup analyses showed that CTLA-4 inhibitors had a higher risk of any type of TRAEs, when compared with PD-1 and PD-L1 inhibitors. Meta-regression showed significant correlation between all grade TRAEs and proportion of female. Fatigue and diarrhoea were involved in common TRAEs.
Our study provides a comprehensive overview of ICIs-associated AEs in AG/GEJC. Immunotherapy did not have a significantly increased risk experiencing any type of TRAEs, and ICIs had a more manageable safety profile than chemotherapy. These findings provide important guidance to clinicians in counseling and management of patients with AG/GEJC.Le texte complet de cet article est disponible en PDF.
Keywords : Immune checkpoint inhibitors, Immunotherapy, Adverse events, Advanced gastric or gastroesophageal junction cancer, Meta-analysis
Abbreviations : AE, AG/GEJC, AST, ALT, BSC, CTLA-4, CTCAE, ECOG, G/GEJC, ICIs, NA, 95% CI, PD‐L1, PD‐1, RCTs, RR, TRAEs