免疫治疗联合放射性^(125)I粒子植入治疗晚期肺癌患者的临床疗效

Clinical efficacy of immunotherapy combined with radioactive ^(125)I seed I implantation in the treatment of advanced lung cancer patients

目的探讨免疫治疗联合放射性^(125)I粒子植入治疗晚期肺癌患者的临床疗效。方法采用区组随机法将50例局部晚期肺癌患者分为对照组和研究组,每组25例,对照组患者给予放射性^(125)I粒子植入治疗,研究组患者给予放射性^(125)I粒子植入联合卡瑞利珠单抗治疗。比较两组患者的主要观察终点(肿瘤直径、随访1年的无进展生存期)、次要终点[不良事件、客观缓解率(ORR)、疾病控制率(DCR)]。结果研究组患者的ORR、DCR为80.00%、96.00%,与对照组患者的88.00%、100%比较,差异均无统计学意义(P﹥0.05)。接受^(125)I粒子植入治疗的25例对照组患者,均未发生不良事件。接受^(125)I粒子植入联合免疫治疗的25例研究组患者中,任意级别免疫相关不良事件(irAE)的发生率为88.00%,其中1~2级irAE发生率为84.00%,3~5级irAE发生率为4.00%,所有级别最常见irAE为乏力,发生率为44.00%。截至随访结束,对照组患者的中位无进展生存期为3.00个月(95%CI:2.543~3.457),明显短于研究组患者的8.00个月(95%CI:5.552~10.448),差异有统计学意义(P﹤0.01)。治疗后,研究组患者的肿瘤直径小于本组治疗前和对照组,差异均有统计学意义(P﹤0.05)。结论卡瑞利珠单抗联合放射性^(125)I粒子植入治疗,可以延长晚期肺癌患者的中位无进展生存期,减小肿瘤直径。

Objective To investigate the clinical efficacy of immunotherapy combined with radioactive ^(125)I seed im-plantation in the treatment of advanced lung cancer patients.Method A total of 50 patients with locally advanced lung cancer were divided into control group and study group by the block randomization method,with 25 cases in each group.Patients in the control group were treated with radioactive ^(125)I seed implantation,and patients in the study group were treated with camrelizumab combined with radioactive ^(125)I seed implantation.The primary endpoints(tumor diameter,one year follow-up progression-free survival),secondary endpoints[adverse events,objective response rate(ORR),disease control rate(DCR)]were compared between the two groups.Result The ORR and DCR of the study group patients were 80.00% and 96.00%,and there were no statistically significant differences compared to the 88.00%and 100%of the control group patients(P>0.05).No adverse events occurred in the 25 patients in the control group who received ^(125)I seed implantation.Among the 25 patients in the study group who received immunotherapy combined with ^(125)I seed implanta-tion,the incidence of immune-related adverse events(irAE)of any grade was 88.00%,among which the incidence of grade 1-2 irAE was 84.00%,and the incidence of grade 3-5 irAE was 4.00%.The most common irAE of all grades was fa-tigue,with an incidence rate of 44.00%.As of the end of follow-up,the median progression-free survival of the control group was 3.00 months(95%CI:2.543-3.457),which was significantly shorter than the 8.00 months(95%CI:5.552-10.448)of the study group,and the difference was statistically significant(P<0.01).After treatment,the tumor diameter of the study group was smaller than that before the treatment and control group,and the differences were statistically sig-nificant(P<0.05).Conclusion Camrelizumab combined with radioactive ^(125)I seeds implantation can prolong the median progression-free survival period of patients with advanced lung cancer and reduce the tumor diameter.