卡瑞利珠联合靶向治疗原发性肝癌患者疗效及安全性分析

Efficacy and safety of camrelizumab and sorafenib combination therapy in the treatment of patients with advanced hepatocellular carcinoma

目的观察卡瑞利珠单抗联合索拉非尼治疗晚期原发性肝癌(PLC)患者的临床疗效和安全性。方法2021年1月~2023年1月我科收治的62例晚期肝细胞癌(HCC)患者,其中31例观察组接受卡瑞利珠单抗联合索拉非尼治疗,另31例对照组仅接受索拉非尼治疗,观察两组近期疗效和不良反应。结果观察组客观缓解率(ORR)为41.9%,疾病控制率(DCR)为87.1%,均显著高于对照组的16.1%和64.5%(P<0.05);截止到2023年9月30日,观察组9例(29.0%)生存,对照组8例(25.8%,P>0.05)生存;观察组中位无进展生存期(PFS)为7.3个月【95%置信区间(CI):5.66~8.94),中位总体生存期(OS)为15.6个月(95%CI:11.84~19.34)】,对照组分别为4.9个月(95%CI:3.92~5.88)和10.1个月(95%CI:8.59~11.71),差异均有统计学意义(P<0.05);观察组免疫性甲状腺炎、反应性皮肤毛细血管增生症和疲乏发生率分别为25.8%、32.2%和64.5%,均显著高于对照组的0.0%、0.0%和35.5%(P<0.05)。结论应用卡瑞利珠单抗联合索拉非尼治疗晚期HCC患者能获得较好的近期疗效,延长患者生存期,不良反应可控,值得临床进一步验证。

Objective This study was aimed at investigating clinical efficacy and safety of camrelizumab and sorafenibcombination therapy in the treatment of patients with advanced hepatocellular carcinoma(aHCC).Method 62 consecutive patients with aHCC were encountered in our hospital between January 2021 to January 2023,and we assigned them to receive camrelizumab and sorafenib combination or to receive sorafenib alone treatment.All patients were followed-up to September 30,2023.Results Objective response rate was 41.9%,and disease control rate was 87.1%,both much higher than 16.1%and 64.5%(P<0.05)in the control;up to September 30,9 patients(29.0%)in the combination group and 8 patients(25.8%,P>0.05)in sorafenib-treated group survived;in combination group,median progression free survival was 7.3 mon(95%CI:5.66-8.94),and overall survival was 15.6 mon(95%CI:11.84-19.34),while in the control,they were 4.9 mon(95%CI:3.92-5.88)and 10.1 mon(95%CI:8.59-11.71),both significantly different between the two groups(P<0.05);the incidence of immune thyroiditis was 25.8%,reactive cutaneous capillary hyperplasia was 32.2%and fatigue was 64.5%in the combination group,much higher than 0.0%,0.0%and 35.5%(P<0.05)in the control.Conclusion Combination of camrelizumab and sorafenib in the treatment of patients with aHCC is encouraging,which might prolong survival and the adverse effect is under control.