信迪利单抗联合SOX方案在Ⅲ期胃癌辅助治疗中的疗效与安全性分析

Analysis of efficacy and safety of sintilimab combined with SOX regimen in adjuvant treatment of stage Ⅲ gastric cancer

    摘要
  • 摘要:
    目的 探讨信迪利单抗联合SOX方案在Ⅲ期胃癌D2根治术后辅助治疗中的疗效与安全性，为临床个体化治疗提供参考。
    方法 回顾性分析2019年6月至2022年5月于中国人民解放军联勤保障部队第九四〇医院行D2根治术后的245例Ⅲ期胃癌患者临床资料，其中接受单纯SOX方案辅助治疗的180例为对照组，接受信迪利单抗联合SOX方案治疗的65例为试验组。比较两组及不同亚组（HER-2阳性、dMMR、CPS≥5）的3年无病生存（disease-free survival，DFS）率、总生存（overall survival，OS）率及不良反应发生情况。
    结果 试验组3年DFS率（81.5% vs. 59.4%）和OS率（84.6% vs. 70.6%）均显著高于对照组（均P<0.05）；组间分析显示，CPS≥5患者中，试验组3年DFS率（91.5% vs. 67.0%）和OS率（95.7% vs. 71.6%）显著优于对照组（均P<0.05）；试验组组内分析表明，CPS≥5患者的3年DFS率（91.5% vs. 55.6%）和OS率（95.7% vs. 55.6%）显著优于CPS<5的患者（均P<0.05）。试验组总体以及≥3级的肝肾功损伤、甲功异常、结肠炎、肺炎和皮疹等的发生率高于对照组（均P<0.05），其余白细胞减少等不良反应的差异无统计学意义（均P>0.05）。
    结论 信迪利单抗联合SOX方案可显著提高Ⅲ期胃癌术后患者的3年DFS和OS率，尤其在CPS≥5亚组中获益显著，且安全性可控。

     

    Abstract:
    Objective To investigate the efficacy and safety of sintilimab combined with the SOX regimen for adjuvant treatment of stage Ⅲ gastric cancer after D2 radical resection and to provide a reference for individualized clinical treatment.
    Methods The clinical data of 245 patients with stage III gastric cancer who underwent D2 radical resection at the 940th Hospital of the Joint Support Force of the People's Liberation Army from June 2019 to May 2022 were retrospectively analyzed. The 180 patients who received only the SOX regimen were designated the control group, and the 65 patients who received sintilimab combined with the SOX regimen were designated the experimental group. The 3-year disease-free survival (DFS) rate, overall survival (OS) rate, and adverse reactions among the two groups and different subgroups (HER-2 positive, dMMR, CPS ≥5) were compared.
    Results The 3-year DFS (81.5% vs. 59.4%) and OS (84.6% vs. 70.6%) rates in the experimental group were significantly higher than those in the control group (both P<0.05). Group analysis showed that in patients with CPS ≥5, the 3-year DFS (91.5% vs. 67.0%) and OS (95.7% vs. 71.6%) rates within the experimental group were significantly better than those in the control group (both P<0.05). Intra-group analysis within the experimental group showed that the 3-year DFS rate (91.5% vs. 55.6%) and OS rate (95.7% vs. 55.6%) of patients with CPS ≥5 were significantly better than those of patients with CPS <5 (both P<0.05). The overall and grade ≥3 incidences of liver and kidney function damage, thyroid dysfunction, colitis, pneumonia, and rash in the experimental group were higher than those in the control group (all P<0.05), while the differences in other adverse reactions, including leukopenia were not statistically significant (all P>0.05).
    Conclusions Sintilimab combined with the SOX regimen can significantly improve 3-year DFS and OS rates in patients with stage Ⅲ gastric cancer after surgery, especially in the CPS ≥5 subgroup, with significant benefits and controllable safety.

     

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