Abstract
BACKGROUND: This study evaluated the efficacy and safety of a regimen consisting of sintilimab, nanoparticle polymeric micellar paclitaxel (NPMP) and S-1 in HER2-negative advanced gastric cancer (AGC). METHOD: In this real-world study, patients with HER2-negative AGC received first-line sintilimab plus NPMP and S-1. The primary endpoint was overall survival (OS) and progression free survival (PFS), while objective response rate (ORR), disease control rate (DCR), and safety were evaluated as secondary endpoints. RESULTS: Among 33 enrolled patients, 14 patients (42.4%) achieved partial response (PR), 17 (51.5%) maintained stable disease (SD), 2 (6.1%) showed progressive disease (PD). ORR and DCR were 42.4% and 93.9%. Median OS reached 15.4 months (95%CI: 13.0-17.6), median PFS was 7.8 months (95%CI: 5.8-9.3). Subgroup analysis revealed significant differences in OS and PFS according to PD-L1 expression and cycles of treatment. Observed adverse events (AEs) were fatigue (60.6%), leukopenia (54.5%),anemia (51.5%),thrombocytopenia (36.4%),nausea (30.3%) and vomiting (15.1%). Most toxicities were manageable and predominantly grade 1-2. CONCLUSIONS: The combination of sintilimab, NPMP and S-1 demonstrates promising antitumor effects and controllable toxicity as first-line treatment in patients with HER2-negative with AGC.