摘要
目的探讨卡瑞利珠单抗联合索拉非尼治疗中晚期肝癌的临床效果和安全性。方法 41例中晚期肝癌患者,其中卡瑞利珠单抗联合索拉非尼治疗21例为联合治疗组,索拉非尼单药治疗20例为对照组,随访2.3~18.3个月,分析比较2组患者中位生存期、疾病进展时间、疾病控制率、客观缓解率和不良反应发生情况;采用Kaplan-Meier法分析2组患者生存情况。结果截至末次随访,联合治疗组患者中位总生存期(11.6个月)和中位疾病进展时间(7.1个月)均明显长于对照组(8.2、4.2个月)(P<0.05),疾病控制率(76.2%)、客观缓解率(47.6%)均高于对照组(40.0%、15.0%)(P<0.05)。联合治疗组主要不良反应为高胆红素血症(57.1%)、高血压(52.4%)、手足皮肤反应(47.6%)和谷草转氨酶升高(38.1%),对照组主要不良反应为高胆红素血症(50.0%)、皮疹(45.0%)、腹泻(45.0%)、疲乏(45.0%)和手足皮肤反应(40.0%);联合治疗组不良反应总发生率(85.7%)、≥Ⅲ级不良反应发生率(42.9%)与对照组(75.0%、25.0%)比较差异均无统计学意义(P>0.05),2组均无Ⅳ级不良反应及相关不良反应死亡事件发生。结论与索拉非尼单药治疗相比,卡瑞利珠单抗联合索拉非尼治疗中晚期肝癌可有效延长患者生存时间,耐受性良好。
Objective To investigate the clinical efficacy and safety of camrelizumab combined with sorafenib in the treatment of advanced hepatocellular carcinoma(HCC). Methods Forty-one patients with advanced HCC were divided into 21 patients receiving camrelizumab combined with sorafenib(combined group) and 20 patients receiving sorafenib(control group). All patients were followed up for 2.3 to 18.3 months. The median overall survival, time to progression, disease control rate, objective response rate and adverse reactions were analyzed and compared between two groups. Kaplan Meier method was used to analyze the survival in two groups. Results The final follow-up showed that the overall survival time and time to progression were longer in combined group(11.6, 7.1 months) than those in control group(8.2, 4.2 months)(P<0.05). The disease control rate and objective response rate were higher in combined group(76.2%, 47.6%) than those in control group(40.0%, 15.0%)(P<0.05). The main adverse reactions were hyperbilirubinemia(57.1%), hypertension(52.4%), hand and foot skin reaction(47.6%) and elevated glutamic-oxaloacetic transaminase(38.1%) in combined group, and were hyperbilirubinemia(50.0%), rash(45.0%), diarrhoea(45.0%), fatigue(45.0%) and hand and foot skin reaction(40.0%) in control group. There were no significant differences in the total incidence of adverse reactions and incidence of grade Ⅲ adverse reactions between combined group(85.7%, 42.9%) and control group(75.0%, 25.0%)(P>0.05). There was no grade Ⅳ adverse reactions or related death in two groups.Conclusion Compared with sorafenib, carrelizumab combined with sorafenib caneffectively prolong the survival time of patients with advanced HCC,and it is well tolerated.
作者
朱帝文
杨胜利
李一帆
顾俊鹏
任伟新
张海潇
鲍应军
曹耿飞
阿斯哈尔·哈斯木
ZHU Di-wen;YANG Sheng-li;LI Yi-fan;GU Jun-peng;REN Wei-xin;ZHANG Hai-xiao;BAO Ying-jun;CAO Geng-fei;Asihaer HASIMU(Department of Interventional Radiology,the First Affiliated Hospital of Xinjiang Medical University,Urumqi,Xinjiang Uygur Autonomous Region 830054,China)
出处
《中华实用诊断与治疗杂志》
2021年第10期1063-1067,共5页
Journal of Chinese Practical Diagnosis and Therapy
基金
国家自然科学基金(82060334)。
关键词
肝细胞癌
免疫治疗
靶向治疗
hepatocellular carcinoma
immunotherapy
targeted therapy