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多纳非尼联合PD-1抑制剂及血管介入治疗在不可切除肝细胞癌中的临床效果观察
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| 篇名： | 多纳非尼联合PD-1抑制剂及血管介入治疗在不可切除肝细胞癌中的临床效果观察 |
| TITLE： | Clinical efficacy of donafenib combined with PD-1 inhibitor and vascular intervention therapy in the treatment of unresectable hepatocellular carcinoma |
| 摘要： | 目的 观察多纳非尼联合程序性死亡受体1（PD-1）抑制剂及血管介入治疗在不可切除肝细胞癌（HCC）中的临床效果。方法回顾性选取2022年6月至2023年3月苏州大学附属第四医院和苏州大学附属第一医院接受PD-1抑制剂（替雷利珠单抗或者信迪利单抗，下同）联合血管介入治疗（对照组，89例）和多纳非尼联合PD-1抑制剂及血管介入治疗（观察组，76例）共计165例不可切除HCC患者的临床资料。比较两组患者的近期疗效（治疗后3个月）、远期疗效（治疗后2年），治疗前和治疗3个月后的肝功能指标（血清丙氨酸氨基转移酶、天冬氨酸氨基转移酶、总胆红素）和肿瘤标志物（血清甲胎蛋白、癌胚抗原、糖类抗原19-9、异常凝血酶原）水平，以及治疗期间的药物不良反应（ADR）发生情况；并对总有效率（ORR）进行基于PD-1抑制剂种类的亚组分析。结果治疗后，观察组患者的ORR显著高于对照组（P＜0.05），疾病控制率虽然高于对照组但差异无统计学意义（P＞0.05）。观察组患者的中位总生存期为16.9个月[95%置信区间（CI）为14.2～19.1个月]，显著长于对照组（12.4个月，95%CI为10.1～15.3个月）（P＜0.05）。亚组分析结果显示，该疗效优势在信迪利单抗亚组与替雷利珠单抗亚组中的趋势一致，且亚组间无显著异质性（P＞0.1，I2＜0.001%）。治疗前，两组患者的上述肝功能指标和肿瘤标志物水平比较，差异均无统计学意义（P＞0.05）；治疗后，两组患者的肝功能指标和肿瘤标志物水平均较治疗前显著降低（P＜0.05），且观察组降低得更明显（P＜0.05）。两组患者的ADR总发生率和3级及以上ADR的发生率比较，差异均无统计学意义（P＞0.05）。结论对于不可切除的HCC患者，多纳非尼联合PD-1抑制剂及血管介入治疗有望能获得较好的临床疗效，且不增加治疗相关的ADR风险。 |
| ABSTRACT： | OBJECTIVE To observe the clinical efficacy of donafenib combined with programmed death-1 （PD-1） inhibitors and vascular intervention therapy in the treatment of unresectable hepatocellular carcinoma （HCC）. METHODS This retrospective study included 165 patients with unresectable HCC who were treated at the Fourth and First Affiliated Hospitals of Soochow University between June 2022 and March 2023. Among them， 89 patients received PD-1 inhibitors （tislelizumab or sintilimab， similarly hereinafter） plus vascular intervention （control group） and 76 patients received donafenib in combination with PD-1 inhibitors and vascular intervention （observation group）. Short-term efficacy （3 months after treatment）， long-term efficacy （2 years after treatment）， the levels of liver function indexes [serum alanine amino-transferase （ALT）， aspartate transferase （AST）， and total bilirubin （TBil）] and tumor biomarkers [alpha fetoprotein （AFP）， carcinoembryonic antigen （CEA）， carbohydrate antigen 19-9 （CA19-9）， and des-gamma-carboxy prothrombin （DCP）] before treatment and after 3 months of treatment， as well as the occurrence of adverse drug reaction （ADR） during treatment， were compared between the two groups. In addition， overall response rate （ORR） stratified by PD-1 inhibitor type was analyzed. RESULTS After treatment， the ORR was significantly higher in the observation group than in the control group （P＜0.05）； although the disease control rate was higher in the observation group compared to the control group， the difference was not statistically significant （P＞0.05）. The median overall survival of patients in the observation group was 16.9 months [95% confidence interval （CI）： 14.2 to 19.1 months]， which was significantly longer than that in the control group （12.4 months， 95%CI： 10.1 to 15.3 months） （P＜0.05）. Subgroup analysis result indicated that therapeutic advantage was consistent across both sintilimab and tislelizumab subgroups， with no significant heterogeneity （P＞0.1， I 2＜0.001%）. Before treatment， there were no significant differences in liver function indexes or tumor marker levels between 2 groups （P＞0.05）. After treatment， both groups showed significant declines in these indicators compared with baseline （P＜0.05）， with greater reductions observed in the observation group （P＜0.05）. There were no statistically significant differences in overall incidence of ADR and grade ≥3 ADRs between the two groups （P＞0.05）. CONCLUSIONS For patients with unresectable HCC， the combination of donafenib， PD-1 inhibitors and vascular intervention therapy may achieve superior clinical outcomes without increasing the risk of treatment-related ADR. |
| 期刊： | 2025年第36卷第21期 |
| 作者： | 苏兰；朱婧菡；刘明明；杨雅蓉；张育；陈祖涛 |
| AUTHORS： | SU Lan，ZHU Jinghan，LIU Mingming，YANG Yarong，ZHANG Yu，CHEN Zutao |
| 关键字： | 多纳非尼；程序性死亡受体1抑制剂；血管介入治疗；肝细胞癌；替雷利珠单抗；信迪利单抗；临床疗效 |
| KEYWORDS： | donafenib； programmed death-1 inhibitor； vascular intervention； hepatocellular carcinoma； tislelizumab； |
| 阅读数： | 4 次 |
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