甲胎蛋白应答评价索拉非尼联合卡瑞利珠单抗治疗晚期肝细胞癌的效果分析

Value of alpha-fetoprotein response in evaluating the efficacy of sorafenib combined with camrelizumab in treatment of advanced hepatocellular carcinoma

目的探讨甲胎蛋白(AFP)应答在索拉非尼联合卡瑞利珠单抗治疗晚期肝细胞癌中的临床疗效及安全性。方法选取2020年9月—2022年2月于新疆医科大学第一附属医院接受索拉非尼联合卡瑞利珠单抗治疗的48例晚期肝细胞癌患者的临床资料,按照治疗后AFP应答水平进行分组:应答组(治疗6~8个月时,与基础AFP比较,AFP下降率>20%,n=32);无应答组(治疗6~8个月时,与基础AFP比较,AFP下降率≤20%,n=16)。计量资料组间比较采用Mann-Whitney U检验;计数资料组间比较采用χ^(2)检验。绘制生存曲线,行Cox单因素/多因素回归分析得到与OS相关的独立危险因素。比较两组患者无进展生存时间、总生存期与治疗效果。结果两组患者中均未观察到达到临床缓解的病例。AFP应答组的客观有效率(21.88%vs 0)和疾病控制率(84.38%vs 43.75%)均高于无应答组(χ^(2)值分别为2.530、6.668,P值分别为0.112、0.010)。应答组无进展生存期(9.9个月)、总生存期(13.8个月)均高于无应答组(6.8个月、11.1个月)。AFP早期无应答(HR=2.624,95%CI:1.097~6.277,P=0.030)及肝外转移(HR=0.392,95%CI:0.157~0.978,P=0.045)与较短的无进展生存期独立相关。未出现因不良反应导致停药事件的发生。结论AFP早期应答在预测索拉非尼联合卡瑞利珠单抗治疗晚期肝细胞癌患者疗效及预后方面具有较高的临床价值。

Objective To investigate the value of alpha-fetoprotein(AFP)response in evaluating the clinical efficacy and safety of sorafenib combined with camrelizumab in the treatment of advanced hepatocellular carcinoma(HCC).Methods Clinical data were collected from 48 patients with advanced HCC who were treated with sorafenib combined with camrelizumab in The First Affiliated Hospital of Xinjiang Medical University from September 2020 to February 2022,and according to the level of AFP response after treatment,they were divided into response group with 32 patients(AFP after 6-8 months of treatment was reduced by more than 20%compared with baseline AFP)and non-response group with 16 patients(AFP after 6-8 months of treatment was reduced by less than 20%compared with baseline AFP).The Mann-Whitney U test was used for comparison of continuous data between groups,and the chi-square test was used for comparison of categorical data between groups.Survival curves were plotted,and univariate and multivariate Cox regression analyses were used to investigate the independent risk factors for overall survival(OS).Progression free survival(PFS)time,OS time,and treatment outcome were compared between the two groups.Results No patient achieved clinical remission in either group.Compared with the non-response group,the response group had significantly higher objective response rate(21.88%vs 0,χ^(2)=2.530,P=0.112)and disease control rate(84.38%vs 43.75%,χ^(2)=6.668,P=0.010).Compared with the non-response group,the response group had longer PFS time(9.9 months vs 6.8 months)and OS time(13.8 months vs 11.1 months).Early non-response of AFP(hazard ratio[HR]=2.624,95%confidence interval[CI]:1.097-6.277,P=0.030)and extrahepatic metastasis(HR=0.392,95%CI:0.157-0.978,P=0.045)were independently associated with a shorter PFS time.No adverse event leading to drug withdrawal was observed in the study.Conclusion Early AFP response has a high clinical value in predicting the efficacy of sorafenib combined with camrelizumab in the treatment of advanced HCC and the prognosis of such patients.