仑伐替尼、替雷利珠单抗及其联合治疗BCLC B/C期肝癌患者的疗效及安全性观察OA
Efficacy and safety of lenvatinib,tislelizumab and their combination in treatment of patients with BCLC stage B/C liver cancer
目的 探讨仑伐替尼、替雷利珠单抗及其联合治疗巴塞罗那临床肝癌分期(BCLC)B/C期肝癌患者的疗效及安全性.方法 选取郑州市第六人民医院2020年4月至2022年4月B/C期肝癌120例患者作为研究对象.采用随机数余数法进行分组,根据余数分配组别:余数为1者分至仑伐替尼组,余数为2者分至替雷利珠单抗组,余数为0者分至联合组,每组40例.比较三组患者的肿瘤缓解情况、不良事件及随访2年生存预后[无进展生存期(PFS)、总生存期(OS)].结果 随访期间出现病例脱落,最终仑伐替尼组纳入37例,替雷利珠单抗组纳入38例,联合组纳入37例进行统计分析.联合组的部分缓解率(PR)、客观缓解率(ORR)和疾病控制率(DCR)均高于替雷利珠单抗组,其疾病进展率(PD)低于替雷利珠单抗组;同时,联合组的PD低于仑伐替尼组,DCR高于仑伐替尼组(P<0.05).三组间不良事件发生率比较,差异无统计学意义(P>0.05).随访24个月,仑伐替尼组的中位PFS为13.4个月(95%CI:5.8～21.0),替雷利珠单抗组的中位PFS为9.3个月(95%CI:6.2～12.4),联合组的中位PFS为21.3个月(95%CI:18.7～23.8),均高于另外两组(log-rank χ2=8.646,P=0.013),仑伐替尼组与替雷利珠单抗组的中位PFS比较,差异无统计学意义(P>0.05).仑伐替尼组中位OS为19.4个月(95%CI:15.2～23.6),替雷利珠单抗组的中位OS为17.5个月(95%CI:12.4～22.6),联合组在随访结束时未达到中位OS,其生存预后优于另外两组(log-rank χ2=9.887,P=0.007),仑伐替尼组与替雷利珠单抗组的中位OS比较,差异无统计学意义(P>0.05).结论 仑伐替尼联合替雷利珠单抗治疗BCLC B/C期肝癌的疗效优于单药治疗,能提升ORR、DCR,延长PFS和OS.
[Objective]To investigate the efficacy and safety of lenvatinib,tislelizumab and their combination in the treatment of patients with Barcelona Clinic Liver Cancer(BCLC)stage B/C liver cancer.[Methods]A total of 120 patients with stage B/C liver cancer in the Sixth People's Hospital of Zhengzhou from April 2020 to April 2022 were selected and divided into three groups according to the random number remainder method,with 40 cases in each group.The patients were assigned to lenvatinib group with a remainder of 1 point,tislelizumab group with a remainder of 2 points,and combined group with a remainder of 0 points.The tumor remission status,adverse events and 2-year survival prognosis[progression-free survival(PFS),overall survival(OS)]were compared among the three groups of patients.[Results]During follow-up of this study,there were cases of shedding.Finally,37 cases in lenvatinib group,38 cases in tirelizumab group and 37 cases in combined group were included for statistical analysis.Compared with the tislelizumab group,the combined group had significantly higher partial remission rate,objective remission rate(ORR),and disease control rate(DCR),and a lower progressive disease(PD)rate(P<0.05).Compared with the lenvatinib group,the combined group also showed a lower PD rate and a higher DCR(P<0.05).There were no statistical differences in the incidence rates of adverse events among the three groups(P>0.05).After 24 months of follow-up,the median PFS in lenvatinib group was 13.4 months(95%CI:5.8-21.0),and that in tislelizumab group was 9.3 months(95%CI:6.2-12.4),and that in combined group was 21.3 months(95%CI:18.7-23.8),which was higher than the other two groups(log-rank χ2=8.646,P=0.013).There was no statistical significance in the median PFS between lenvatinib group and tislelizumab group(P>0.05).The median OS was 19.4 months(95%CI:15.2-23.6)in lenvatinib group and 17.5 months(95%CI:12.4-22.6)in tislelizumab group.The combined group did not reach the median OS at the end of follow-up.The survival prognosis in combined group was better than that in the other two groups(log-rank χ2=9.887,P=0.007),and no statistical difference was observed in the median OS between lenvatinib group and tislelizumab group(P>0.05).[Conclusion]The efficacy of lenvatinib combined with tislelizumab in the treatment of BCLC stage B/C liver cancer is better than that of monotherapy,which can improve ORR and DCR,and prolong PFS and OS.
孟雪;李广明;胡善雷;张敏敏
郑州市第六人民医院 肝硬化科,河南 郑州 450000郑州市第六人民医院 肝硬化科,河南 郑州 450000郑州市第六人民医院 肝硬化科,河南 郑州 450000郑州市第六人民医院 肝硬化科,河南 郑州 450000
医药卫生
肝细胞癌仑伐替尼替雷利珠单抗疗效安全性
hepatocellular carcinomalenvatinibtislelizumabefficacysafety
《中国医学工程》 2026 (3)
34-39,6
河南省2024年科技发展计划(242102310388)
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