肝动脉化疗栓塞联合靶向及免疫检查点抑制剂治疗对中晚期肝癌患者的疗效及安全性研究

Effect and safety of TACE combined with targeted therapy and immune checkpoint inhibitors in patients with intermediate and advanced hepatocellular carcinoma

  • 摘要:
      背景  免疫检查点抑制剂目前已在多种实体肿瘤治疗中取得了初步成果,但其联合靶向及局部介入治疗对中晚期肝癌患者的疗效有待进一步研究。
      目的  探讨肝动脉化疗栓塞(trans arterial chemoembolization,TACE)联合靶向药物及免疫检查点抑制剂对中晚期肝癌患者的治疗疗效及安全性。
      方法  收集2016年1月 - 2021年1月就诊于解放军总医院第一医学中心经病理学或临床诊断为中晚期肝细胞肝癌患者的临床资料,根据不同治疗方案分为两组,观察组患者采用TACE + 靶向药物 + 免疫检查点抑制剂治疗,对照组患者应用TACE联合靶向药物治疗,分析两组的客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)、总生存期(overall survival,OS)及不良反应。
      结果  观察组98例,男性83例,女性15例,平均年龄为 55.5岁;对照组52例,男性43例,女性9例,平均年龄为53.7岁。两组年龄和性别差异无统计学意义(P>0.05)。观察组和对照组患者的ORR分别为56.1%和38.5%,DCR分别为81.6%和69.2%,中位总生存期分别为23.1个月和16.27个月,以上差异均有统计学意义(P均<0.05)。观察组最常见的不良反应为高血压(22.4%),其次为腹泻(21.4%)、手足反应(20.4%),而对照组最常见的不良反应为手足反应(32.7%),其次为腹泻(19.2%)、高血压(15.4%),两组各不良反应发生率差异无统计学意义(P>0.05)。
      结论  TACE联合靶向药物及免疫检查点抑制剂为延长中晚期肝癌患者的生存时间带来了希望,有望推动局部介入与药物联合治疗的新局面。

     

    Abstract:
      Background  Immune checkpoint inhibitors have achieved preliminary results in the treatment of a variety of solid tumors, but the efficacy of their combined targeting and local intervention in patients with intermediate and advanced hepatocellular carcinoma needs to be further studied.
      Objective  To investigate the efficacy and safety of trans arterial chemoembolization (TACE) combined with targeted drugs and immune checkpoint inhibitors in patients with intermediate and advanced hepatocellular carcinoma.
      Methods  Clinical data about patients with hepatocellular carcinoma diagnosed pathologically or clinically in the First Medical Center of Chinese PLA General Hospital from January 2016 to January 2021 were retrospectively collected. A total of 150 patients with intermediate and advanced hepatocellular carcinoma were enrolled according to different treatment regimens, 98 patients in the observation group were treated with TACE combined with targeted drugs and immune checkpoint inhibitors, 52 patients in the control group were treated with TACE combined with targeted drugs. The objective response rate (ORR), disease control rate (DCR), overall survival (OS) and adverse reactions of the two groups were analyzed.
      Results   There were 98 cases in the observation group, including 83 males and 15 females, with an average age of 55.5 years. Fifty-two cases were in the control group, including 43 males and 9 females, with an average age of 53.7 years. There was no statistically significant difference in age and gender between the two groups (P>0.05). The ORR of the observation group and the control group was 56.1% and 38.5%, respectively, and the DCR was 81.6% and 69.2%, respectively. The median overall survival (mOS) was 23.1 months and 16.27 months, respectively (all P<0.05). The most common adverse events were hypertension (22.4%), diarrhea (21.4%), hand-foot syndrome (20.4%) in the observation group, and hand-foot syndrome(32.7%), diarrhea (19.2%), hypertension (15.4%) in the control group, showing no significant differences between the two groups (P>0.05).
      Conclusion  TACE combined with targeted drugs and immune checkpoint inhibitors brings hope to prolong the survival time of patients with intermediate and advanced hepatocellular carcinoma, which is expected to promote the new situation of local intervention and drug combination therapy.

     

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