信迪利单抗联合贝伐珠单抗对晚期肝细胞癌的真实世界研究

Real-world study of sintilimab combined with bevacizumab in patients with advanced hepatocellular carcinoma

目的探究信迪利单抗联合贝伐珠单抗对晚期肝细胞癌(HCC)的临床疗效和安全性。方法回顾性选取2021年1月至2023年1月徐州市肿瘤医院诊治的晚期HCC患者为研究对象。根据治疗方案,将晚期HCC患者分为索拉非尼组(索拉非尼治疗)和单抗组(信迪利单抗+贝伐珠单抗治疗)。主要研究终点为无进展生存期(PFS)和总生存期(OS),次要研究终点为客观反应率(ORR)和疾病控制率(DCR)。根据不良事件通用术语标准(CTCAE 4.03)评估不良反应发生情况。结果共纳入108例晚期HCC患者,索拉非尼组36例,单抗组72例。单抗组中位PFS和OS显著高于索拉非尼组(P<0.05)。单抗组ORR显著高于索拉非尼组(P<0.05),但两组DCR差异无统计学意义(P>0.05)。不良反应方面,两组均未发生致命不良反应,不良反应发生情况相似。结论与索拉非尼相比,信迪利单抗联合贝伐珠单抗在晚期HCC中可获得更好的OS和PFS,且安全性良好。

Objective To explore the clinical efficacy and safety of sintilimab combined with bevacizumab in the treatment of advanced hepatocellular carcinoma(HCC).Methods Patients with advanced HCC diagnosed and treated in Xuzhou Cancer Hospital from January 2021 to January 2023 were retrospectively selected as study subjects.According to the treatment regimen,patients with advanced HCC were categorized into the sorafenib group(sorafenib treatment)and the monoclonal antibody group(sindilizumab+bevacizumab treatment).The primary study endpoints were progression-free survival(PFS)and overall survival(OS),and the secondary study endpoints were objective response rate(ORR)and disease control rate(DCR).The occurrence of adverse reactions was assessed according https://zgys.whuznhmedj.com to the Common Terminology Criteria for Adverse Events(CTCAE 4.03).Results A total of 108 patients with advanced HCC were enrolled,36 in the sorafenib group and 72 in the monoclonal antibody group.The median PFS and OS were significantly higher in the monoclonal antibody group than in the sorafenib group(P<0.05).The ORR in the monoclonal antibody group was significantly higher than that in the sorafenib group(P<0.05),but the difference in DCR between the two groups was not statistically significant(P>0.05).Regarding adverse reactions,no fatal adverse reactions occurred in both groups,and the occurrence of adverse reactions was similar.Conclusion Compared with sorafenib,sindilizumab combined with bevacizumab resulted in better OS and PFS in advanced HCC with a favorable safety profile.