Efficacy and Safety of Tislelizumab in Combination with Chemotherapy versus Placebo Plus Chemotherapy in Patients with Advanced Gastric Cancer or Gastroesophageal Junction Cancer: A Systematic Review of Randomized Controlled Trials

Abstract

Introduction: Advanced gastric cancer or gastroesophageal junction cancer (GC/GEJC) is an aggressive malignancy often having a poor prognosis. Despite current systemic therapies, GC/GEJC remains the third most common cause of cancer-related deaths worldwide. Tislelizumab, an anti-PD1 antibody, has shown promising results in treating various cancers. Therefore, this systematic review investigated the efficacy and safety of tislelizumab plus chemotherapy for patients with GC/GEJC. Methods: Five databases were systematically searched until July 10, 2024. Articles identified in the screening process included two RCTs based on predefined inclusion criteria. We performed data extraction sheets and quality assessments using the Cochrane ROB2 tool. Results: Out of the two randomized controlled trials (RCTs), 1646 patients were included in our systematic review. In Rational-306, efficacy outcomes improved, overall survival (OS) significantly improved from 10.6 months (95\% CI 9.3–12.1) to 17.2 months (95\% CI 15.8–20.1), and progression-free survival (PFS) from 5.6 months (4.9–6.0) to 7.3 months (6.9–8.3). Rational-305 also notably significantly improved. Outcomes: Improved OS from 12.9 months (12.1-14.1) to 15 months (13.6-16.5), and PFS from 6.2 months (5.6 to 6.9) to 6.9 months (5.7 to 7.2). The proportion of patients with any grade 3 or worse treatment-related adverse events was similar between treatment groups. Conclusion: Compared with chemotherapy and placebo, Tislelizumab plus chemotherapy demonstrates superior efficacy with a similar safety profile in the two groups, encouraging the use of the tislelizumab group in patients with GC/GEJC