信迪利单抗联合白紫+替吉奥二线治疗Her-2阴性胃癌的近远期疗效和安全性研究

Short-term and Long-term Efficacy and Safety of Xindili Monoclonal Antibody Combined with Baizi+Tegafur in the Second-line Treatment of Her-2 Negative Gastric Cancer

目的:分析信迪利单抗联合白紫+替吉奥(S-1)二线在人表皮生长因子受体2(Her-2)阴性胃癌治疗中的近远期疗效及其安全性。方法:根据随机数字表法将2018年1月~2021年1月在本院接受治疗的76例Her-2阴性胃癌患者分为对照组与观察组,每组各38例,对照组给予白紫+替吉奥二线治疗,观察组给予白紫+替吉奥二线+信迪利单抗治疗;观察两组患者的近期疗效和不良反应发生率,并在随访24个月后记录两组患者的远期疗效,Logistic多因素分析影响患者达到中位OS、PFS的独立危险因素。结果:与对照组比较,观察组ORR、DCR率较高(P<0.05);与对照组比较,观察组中位OS、PFS较高(P<0.05);Logistic多因素分析结果显示,治疗方法(白紫+替吉奥二线)是影响HER-2阴性胃癌达到中位PFS和OS的独立危险因素(P<0.05);两组不良反应发生率比较无差异(P>0.05)。结论:白紫、替吉奥二线与信迪利单抗联合治疗不仅能保障Her-2阴性胃癌治疗的安全性,还能进一步提升患者的临床治疗效果,并延长其生存期。

Objective:To analyze the short-term and long-term efficacy and safety of Xindilimab combined with S-1 in the treatment of human epidermal growth factor receptor 2(Her-2)negative gastric cancer.Methods:According to the random number table method,76 patients with Her-2 negative gastric cancer who were treated in our hospital from January 2018 to January 2021 were divided into control group and observation group,38 cases in each group.The control group was given white violet+tegafur second-line treatment,and the observation group was given white violet+tegafur second-line+sintilizumab treatment;the short-term efficacy and incidence of adverse reactions of the two groups were observed,and the long-term efficacy of the two groups was recorded after 24 months of follow-up.Logistic multivariate analysis was used to analyze the independent risk factors affecting the median OS and PFS of patients.Results:Compared with the control group,the ORR and DCR rates of the observation group were higher,and the difference was statistically significant(P<0.05).Compared with the control group,the median OS and PFS of the observation group were higher,and the difference was statistically significant(P<0.05).Logistic multivariate analysis showed that the treatment method(white purple+S-1 second-line)was an independent risk factor affecting the median PFS and OS of HER-2 negative gastric cancer(P<0.05).There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05).Conclusion:The combination of white purple,tegio second-line and sintilimab can not only ensure the safety of Her-2 negative gastric cancer treatment,but also further improve the clinical treatment effect of patients and prolong their survival.