替雷利珠单抗联合索拉非尼治疗不可切除肝细胞性肝癌的疗效和安全性

Efficacy and safety of tislelizumab combined with sorafenib in the treatment for unresectable hepatocellular carcinoma

目的分析替雷利珠单抗(TIS)联合索拉非尼(SRF)一线治疗方案对不可切除肝细胞性肝癌(HCC)的临床疗效和安全性。方法回顾性分析2020年1月至2023年1月浙江大学医学院附属金华医院及树兰(杭州)医院诊治的不可切除HCC患者的临床资料。根据诊疗方案分为联合组(TIS联合SRF)和对照组(SRF)。研究主要观察指标为客观反应率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)和总生存期(OS)。此外,关注治疗过程中不良反应发生情况评估安全性。结果研究共纳入患者61例,联合组31例、对照组30例。两组ORR差异无统计学意义(P>0.05),而联合组DCR显著高于对照组(P<0.05)。生存分析表明联合组中位PFS、中位OS显著高于对照组(P<0.05)。安全性方面,两组手足综合症、转氨酶升高、食欲减退、蛋白尿、皮疹、腹泻、血小板减少和乏力发生率差异无统计学意义(P>0.05);而联合组发生甲状腺功能减退8例(25.81%),毛细血管增生4例(12.90%),对照组未发生甲状腺功能减退和毛细血管增生。此外,无患者因不良反应死亡或中止治疗。结论较单药SRF比较,TIS联合SRF一线方案治疗不可切除HCC可提高DCR,延长中位PFS和OS,且安全性良好。

Objective To Analyze tislelizumab(TIS)combined with sorafenib(SRF)as the first-line treatment regimen for unresectable hepatocellular carcinoma(HCC).Methods Clinical data of patients with unresectable HCC treated in Jinhua Hospital and Shulan(Hangzhou)Hospital affiliated to Zhejiang University School of Medicine from January 2020 to January 2023 were retrospectively analyzed.They were divided into a combined group(TIS combined with SRF)and a control group(SRF)according to the diagnosis and treatment protocol.The main observational indexes of the study were objective response rate(ORR),disease control rate(DCR),progression-free survival(PFS)and overall survival(OS).In addition,attention was paid to the occurrence of adverse reactions during the treatment to assess safety.Results A total of 61 patients were included in the study,with 31 in the combined group and 30 in the control group.The difference in ORR between the two groups was not statistically significant(P>0.05),while DCR was significantly higher in the combined group than in the control group(P<0.05).Survival analysis showed that the median PFS and median OS of the combined group were significantly higher than those of the control group(P<0.05).In terms of safety,there was no statistically significant difference in the incidence of hand-foot syndrome,transaminase elevation,loss of appetite,proteinuria,rash,diarrhea,thrombocytopenia,and malaise between the two groups(P>0.05);whereas 8 cases of hypothyroidism(25.81%)and 4 cases of capillary hyperplasia(12.90%)occurred in the combined group,and no hypothyroidism or capillary hyperplasia occurred in the control group.In addition,no patients died or discontinued treatment due to adverse effects.Conclusion Compared to single drug SRF,the combination of TIS and SRF first-line treatment for unresectable HCC can improve DCR,prolong median PFS and OS,and the safety is controllable.