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


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Köylü B., Kıkılı C. İ., Kemik ., Demir N., Alan Ö., Laçin Ş., ...Daha Fazla

Annals of Medical Research, cilt.2026, sa.33, ss.91-98, 2026 (TRDizin)

Özet

Aim:This study primarily aimed to assess the efficacy of second-line ramucirumab (RAM) pluspaclitaxel (PTX) in patients with advanced gastric and gastroesophageal junction (GEJ) cancersand to compare its outcomes with those of RAM+PTX plus immune checkpoint inhibitor (ICI) inreal-world practice. The secondary objective was to assess the safety of RAM+PTX (±ICI) andto explore its efficacy in later-line settings.MaterialsandMethods:This single-center study retrospectively analyzed the clinicopathologicdata of patients with advanced gastric/GEJ cancer treated with RAM+PTX, with or without anICI, in second-line or later settings between January 2018 and September 2024. Efficacy wasevaluated 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+PTXplus 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 out-comes (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). Age50 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

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 out-

comes (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 gas-

tric/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 fur-

ther prospective evaluation.

3 adverseevents were more frequent. While adding nivolumab did not confer a statistically significantbenefit, a numerical improvement in ORR and DCR indicates potential value that warrants fur-ther prospective evaluation