Sintilimab Plus Nanoparticle Polymeric Micellar Paclitaxel and S-1 as First-Line Treatment in HER2-Negative Advanced Gastric Cancer: A Real-World Study.

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.