Efficacy and safety of Nivolumab in advanced gastric and gastroesophageal junction cancer: a meta-analysis of randomized controlled trials.

[BACKGROUND] *CoNivolumab, an immune checkpoint inhibitor, has shown promise in treating advanced unresectable gastric and gastroesophageal junction cancer. This meta-analysis aims to evaluate the efficacy and safety of Nivolumab, alone and in combination with chemotherapy, in this patient population.

[METHODS] A systematic review and meta-analysis were conducted according to PRISMA guidelines, using data from PubMed, Embase, CENTRAL, Web of Science, and CNKI up to June 3, 2024. Eight randomized controlled trials (RCTs) involving 3729 patients were included. The primary outcomes were overall survival (OS) and progression-free survival (PFS), while safety was assessed through adverse events (AEs) and grade ≥ 3 AEs. Effect sizes were measured using mean differences (MD) and relative risks (RR), with 95% confidence intervals (CIs).

[RESULTS] Nivolumab significantly extended OS (MD = 2.29, 95% CI: 1.48, 3.09) and PFS (MD = 0.69, 95% CI: 0.32, 1.06) compared to controls. Subgroup analysis showed that both Nivolumab monotherapy (OS: MD = 2.52, 95% CI: 0.81, 4.23; PFS: MD = 0.16, 95% CI: 0.11, 0.22) and Nivolumab combined with chemotherapy (OS: MD = 2.06, 95% CI: 0.56, 3.57; PFS: MD = 1.53, 95% CI: 0.32, 1.06) improved OS and PFS. While the overall risk of AEs was not significantly increased, Nivolumab monotherapy significantly increased the risk of AEs (RR = 1.47, 95% CI: 1.16, 1.87), whereas Nivolumab combined with chemotherapy did not (RR = 1.03, 95% CI: 0.97, 1.09). Both treatments increased the risk of grade ≥ 3 AEs (RR = 1.24, 95% CI: 1.12, 1.36).

[CONCLUSION] Nivolumab, both alone and in combination with chemotherapy, improves OS and PFS in patients with advanced gastric and gastroesophageal junction cancer. However, careful patient monitoring is necessary due to the increased risk of severe AEs, particularly with monotherapy.