程序性细胞死亡受体1抑制剂联合仑伐替尼治疗晚期原发性肝癌的效果及不良反应

目的初步探索国产程序性细胞死亡受体1(PD-1)抑制剂联合仑伐替尼在晚期原发性肝癌治疗中的临床疗效及不良反应。方法回顾性分析2019年1月1日—2020年4月2日于首都医科大学附属北京地坛医院使用国产PD-1抑制剂联合仑伐替尼治疗的24例晚期肝癌患者的临床资料,其中卡瑞利珠单抗联合仑伐替尼治疗组15例,信迪利单抗联合仑伐替尼治疗组7例,特瑞普利单抗联合仑伐替尼组2例。随访患者,肝内病灶使用mRECIST标准、肝外转移灶采用RECIST1.1标准评价疗效。Kaplan-Meier法绘制生存曲线。结果24例肝癌患者中,11例疗效评价为部分缓解,7例疗效评价为疾病稳定,6例疗效评价为疾病进展,客观缓解率为45.8%,疾病控制率为75.0%。中位疾病进展时间为8.40个月(95%CI:6.89~9.91个月)。不良反应发生率为54.17%,最常见的不良反应为疲乏(29.17%)、高血压(25.00%)。结论PD-1抑制剂联合仑伐替尼治疗晚期肝癌临床效果显著,严重不良反应发生率低,是一种安全、有效的治疗方案。

Clinical effect of programmed cell death-1 inhibitor combined with lenvatinib in treatment of advanced primary liver cancer and related adverse events

Objective To investigate the clinical effect of domestic programmed cell death-1(PD-1)inhibitor combined with lenvatinib in the treatment of advanced primary liver cancer and related adverse events.Methods A retrospective analysis was performed for the clinical data of 24 patients with advanced primary liver cancer who were treated with domestic PD-1 inhibitor combined with lenvatinib in Beijing Ditan Hospital,Capital Medical University,from January 1,2019 to April 2,2020,with 15 patients in the Camrelizumab+lenvatinib group,7 patients in the Sintilimab+lenvatinib group,and 2 patients in the Toripalimab+lenvatinib group.During follow-up,Modified Response Evaluation Criteria in Solid Tumors was used to evaluate the treatment outcome of intrahepatic lesions,and RECIST1.1 was used to evaluate extrahepatic metastatic lesions.The Kaplan-Meier method was used to evaluate survival time.Results Among the 24 treatment-experienced patients,11 achieved partial response,7 achieved a stable disease,and 6 had disease progression,resulting in an objective response rate of 45.8%and a disease control rate of 75.0%.The median time to disease progression was 8.4(95%confidence interval:6.89-9.91)months.The incidence rate of adverse events was 54.17%,and the most common adverse events were fatigue(29.17%)and hypertension(25.00%).Conclusion PD-1 inhibitor combined with lenvatinib has a marked clinical effect in the treatment of advanced primary liver cancer,with a low incidence rate of serious adverse events,and thus it is a safe and effective treatment regimen.