Real-world efficacy of ramucirumab plus paclitaxel with or without nivolumab in advanced gastric and gastroesophageal junction cancers

Abstract

Aim: This study primarily aimed to assess the efficacy of second-line ramucirumab (RAM) plus paclitaxel (PTX) in patients with advanced gastric and gastroesophageal junction (GEJ) cancers and to compare its outcomes with those of RAM+PTX plus immune checkpoint inhibitor (ICI) in real-world practice. The secondary objective was to assess the safety of RAM+PTX (±ICI) and to explore its efficacy in later-line settings.

Materials and Methods: This single-center study retrospectively analyzed the clinicopathologic data of patients with advanced gastric/GEJ cancer treated with RAM+PTX, with or without an ICI, in second-line or later settings between January 2018 and September 2024. Efficacy was evaluated based on the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS). We analyzed efficacy outcomes by treatment line.

Results: We identified 46 patients (female, 54.3%) who received RAM+PTX (±ICI). In the second-line setting, 27 patients (58.7%) received RAM+PTX, and 10 patients (21.7%) received RAM+PTX plus nivolumab. The ORRs were 18.5% and 30.0% (p = 0.66), and the DCRs were 55.6% and 80% (p = 0.26), respectively. The addition of nivolumab did not significantly improve survival outcomes (median PFS, 4.3 vs. 3.1 months; HR, 0.93; 95% CI, 0.44-1.98; p = 0.85; median OS, 7.8 vs. 9.6 months; HR, 0.82; 95% CI, 0.35-1.91; p = 0.64). Age ≥50 years (HR, 2.90; 95% CI, 1.24-6.78; p = 0.014) and the presence of ascites (HR, 2.86; 95% CI, 1.14-7.16; p = 0.025) were independently associated with poorer OS.

Conclusion: The real-world efficacy of RAM+PTX as second-line therapy in advanced gastric/GEJ cancers is consistent with the results of randomized trials, though grade ≥3 adverse events were more frequent. While adding nivolumab did not confer a statistically significant benefit, a numerical improvement in ORR and DCR indicates potential value that warrants further prospective evaluation.