信迪利单抗联合抗血管药物用于经导管动脉化疗栓塞术肝癌患者的疗效观察

Therapeutic efficacy of sintilimab combined with anti-vascular drugs in treatment of patients with advanced liver cancer receiving TACE

目的 探究信迪利单联合索拉非尼、经导管动脉化疗栓塞术(TACE)治疗进展期肝癌有效性和安全性。方法 收集2018年1月到2022年9月绍兴市上虞人民医院收治的79例不可切除进展期原发性肝细胞癌患者,按照治疗方法不同分为研究组(n=38,信迪利单抗+索拉非尼+TACE方案治疗)和对照组(n=41,索拉非尼+TACE方案治疗),比较两组患者疾病控制率(DCR)、客观缓解率(ORR)、总生存期(OS)、无进展生存期(PFS)及不良反应。结果 术后1个月研究组ORR高于对照组(60.53%vs 34.15%,χ^(2)=5.512,P=0.019);随访18个月,研究组生存率为78.95%(30/38),对照组生存率为63.41%(26/41),两组总生存率比较差异无统计学意义(P>0.05),其中研究组中位PFS、OS分别为12.0个月、14.9个月,高于对照组7.3个月、10.9个月(long-rankχ^(2)=4.075、4.380,P=0.044、0.036);研究组和对照组发生胃肠道反应(2.6%vs 4.9%)、皮疹(2.6%vs 0%)、高血压(13.2%vs 4.9%)等≥3级不良反应概率比较差异无统计学意义(均P>0.05)。结论 信迪利单抗联合索拉非尼+TACE治疗进展期肝癌可有效提高客观缓解率、延长患者生存时间,且并未明显增加严重不良反应发生率,具有良好的安全性和有效性。

Objective To investigate the efficacy and safety of sintilimab combined with sorafenib+transcatheter arterial chemoembolization(TACE)in the treatment of stageⅢhepatocellular carcinoma.Methods Seventy-nine patients with unresectable advanced primary hepatocellular carcinoma admitted to Shaoxing Shangyu People's Hospital from January 2018 to September 2022 were enrolled in this study and divided into study group(n=38,sintilimab+sorafenib+TACE regimen)and the control group(n=41,sorafenib+TACE regimen)according to the treatment method.Then the disease control rate(DCR),objective remission rate(ORR),overall survival(OS),progression-free survival(PFS)and adverse reactions were compared between the two groups.Results The ORR and DCR in the study group were higher than those in the control group at postoperative 1 month(60.53%vs 34.15%,χ^(2)=5.512,P=0.019).At 18 months of follow-up,the survival rate of the study group was 78.95%(30/38)while that of the control group was 63.41%(26/41).There was no statistically significant difference in the overall survival rate between the two groups(P>0.05).The median PFS and OS of the study group were 12.0 months and 14.9 months,respectively,which were higher than those of the control group at 7.3 months and 10.9 months(long rankχ^(2)=4.075,4.380,P=0.044,0.036).There was no statistically significant difference in the probability of grade 3 adverse reactions such as gastrointestinal reactions(2.6%vs 4.9%),rash(2.6%vs 0%)and hypertension(13.2%vs 4.9%)between the study group and the control group(all P>0.05).Conclusion The combination of sintilimab and Sorafenib+TACE in the treatment of advanced liver cancer can effectively improve the objective remission rate,prolong the survival time of patients and does not significantly increase the incidence of serious adverse reactions,demonstrating good safety and efficacy.