Objective: Recent years have seen breakthrough progress in the use of immune checkpoint inhibitors in cancer therapy, offering new hope for patients with advanced gastric cancer. However, there remains insufficient real-world evidence regarding the efficacy and safety of combining immune checkpoint inhibitors with anti-angiogenic drugs and chemotherapy in the second-line setting. There is a pressing clinical need for dedicated studies to validate its application value. The present investigation systematically evaluated the clinical efficacy and safety profile of a multimodal therapeutic strategy integrating second-line immunotherapeutic agents, cytotoxic chemotherapy, and anti-angiogenic therapy in patients with metastatic gastroesophageal junction adenocarcinoma. Methods: A retrospective analysis was conducted on 84 patients treated in the oncology department. Patients were divided into two groups: the observation group (sintilimab + apatinib + albumin-bound paclitaxel, n = 42) and the control group (apatinib + albumin-bound paclitaxel, n = 42). Outcomes included median overall survival (mOS), median progression-free survival (mPFS), objective response rate (ORR), disease control rate (DCR), and adverse event incidence. Results: Baseline characteristics (age, gender, Eastern Cooperative Oncology Group score, tumor location, histology, Lauren classification, human epidermal growth factor receptor 2 status, programmed death-ligand 1 expression, metastatic status, and prior treatment) showed no significant differences ( P > 0.05), ensuring comparability. After follow-up, there was no significant difference in ORR or DCR between the two groups ( P > 0.05): the observation group exhibited an ORR of 42.85% and DCR of 85.71%, compared to 38.09% and 75.57% in the control group, respectively. Furthermore, there was no significant difference in the overall incidence of adverse events or immune-related adverse events between the groups ( P > 0.05). The incidence of immune-related adverse events was 21.43% (observation group) vs. 23.81% (control group), with no statistical significance ( P = 0.798). The observation group had significantly longer mPFS (12.0 months vs. 9.0 months, hazard ratio (HR) = 0.455, 95% confidence interval CI: 0.217– 0.956; P = 0.028), though mOS showed no difference (HR = 0.384, 95% CI: 0.131– 1.125; P = 0.062). Kaplan-Meier analysis confirmed superior PFS in the observation group. Conclusion: The combination of an anti-PD-1 monoclonal antibody with chemotherapy and anti-angiogenic agents demonstrated preliminary efficacy and favorable safety in second-line gastric cancer patients. This study, using real-world data, validates the clinical benefit of this triple regimen, addresses the evidence gap in second-line treatment options, provides new insights for personalized combination strategies in advanced gastric cancer, and holds significant value for guiding clinical practice. Keywords: gastric cancer, second-line, immunotherapy, anti-angiogenic agents, albumin-bound paclitaxel
Hong et al. (Sun,) studied this question.