ICIs联合TKIs治疗HBV相关肝细胞癌患者疗效研究*

doi:10.3969/j.issn.1672-5069.2023.06.031

实用肝脏病杂志 ›› 2023, Vol. 26 ›› Issue (6): 891-894.doi: 10.3969/j.issn.1672-5069.2023.06.031

ICIs联合TKIs治疗HBV相关肝细胞癌患者疗效研究^*

于双杰, 李元元, 毕京峰, 福军亮, 宓余强

301617 天津市天津中医药大学研究生院(于双杰);解放军总医院第五医学中心I期临床试验病房(于双杰,李元元,毕京峰);解放军总医院第五医学中心感染病科五病区(福军亮); 天津市第二人民医院(宓余强)

收稿日期:2023-07-20 出版日期:2023-11-10 发布日期:2023-11-20
通讯作者: 宓余强,E-mail:yuqiangmi68@163.com
作者简介:于双杰,女,50岁,副主任医师。研究方向:中西医结合治疗肝病研究。E-mail:yusj302@163.com
基金资助:
^* 首都临床诊疗技术研究及转化应用项目(编号:Z201100005520046)

Should the patients with advanced hepatocellular carcinoma get benefits from immunocheckpoint inhibitors and tyrosine kinase inhibitor combination therapy?

Yu Shuangjie, Li Yuanyuan, Bi Jingfeng, et al

Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin 301617,China

Received:2023-07-20 Online:2023-11-10 Published:2023-11-20

摘要/Abstract

摘要： 目的观察应用程序性死亡-1(PD-1)免疫检查点抑制剂(ICIs)和酪氨酸激酶抑制剂(TKIs)联合治疗不能手术切除的乙型肝炎病毒(HBV)相关性肝细胞癌(HCC)患者的疗效。方法 2019年9月～2022年1月我院诊治的无法手术切除的HBV相关性HCC患者44例,其中血清AFP水平正常者16例和升高者28例,均接受信迪利单抗、卡瑞利珠单抗、替雷利珠单抗和仑伐替尼抗肿瘤治疗。本组44例HCC患者治疗2～24个月,中位治疗时间为8(6,26)个月。随访24(10,36)个月。结果本组血清AFP正常和升高组各失访2例;血清AFP正常组客观缓解率(ORR)和疾病控制率(DCR)分别为21.4%和28.6%,与血清AFP升高组的11.5%和23.1%比,无显著性差异(P>0.05);14例血清AFP正常组死亡4例,中位生存时间(mOS)为17.1(14.0,24.0)个月,血清AFP升高组死亡18例,中位生存时间为8.6(4.8,18.1)个月(P=0.01)。结论对于晚期不能手术切除的HCC患者,应用ICIs和TKIs联合治疗,能获得临床效果,延长患者生存期,但血清AFP水平大幅升高的患者是否也可以接受治疗,值得继续研究。

关键词: 肝细胞癌, 程序性死亡-1免疫检查点抑制剂, 酪氨酸激酶抑制剂, 甲胎蛋白, 治疗

Abstract: Objective The aim of this study was to investigate the efficacy of programmed death 1(PD-1) immunocheckpoint inhibitors (ICIs) and tyrosine kinase inhibitor (TKIs) combination in patients with hepatitis B virus (HBV)-associated advanced hepatocellular carcinoma (aHCC). Methods 44 patients with HBV-related unresectable HCC (normal serum AFP level in 16 cases and elevated in 28 cases) were enrolled in Fifth Medical Center, General Hospital of People's Liberation Army between September 2019 and January 2022, and all received sintilimab, camrelizumab, tirelizhu and lenvatinib combination therapy for 2 to 24 months, with median of 8(6, 26) months. All patients were followed-up for 24(10,36) months. Results Both two patients in groups of normal serum AFP and elevated levels lost in our series; the objective remission rate and disease control rate in patients with normal serum AFP level were 21.4% and 28.6%, both not significantly different as compared to 11.5% and 23.1% in patients with elevated serum AFP level (P>0.05); out of the 14 patients with normal serum AFP level, 4 died, with the median overall survival (mOS)of 17.1(14.0, 24.0)mon, while in those with elevated serum AFP level, 18 died, with the mOS of 8.6(4.8, 18.1)mon(P=0.01). Conclusion The patients with unresectable HBV-related HCC might get benefits from the combination of ICIs and TKIs therapy, and the emphasis should put on those with elevated serum AFP levels.

Key words: Hepatoma, Immunocheckpoint inhibitors, Tyrosine kinase inhibitor, Alpha-fetoprotein, Therapy

于双杰, 李元元, 毕京峰, 福军亮, 宓余强. ICIs联合TKIs治疗HBV相关肝细胞癌患者疗效研究^*[J]. 实用肝脏病杂志, 2023, 26(6): 891-894.

Yu Shuangjie, Li Yuanyuan, Bi Jingfeng, et al. Should the patients with advanced hepatocellular carcinoma get benefits from immunocheckpoint inhibitors and tyrosine kinase inhibitor combination therapy?[J]. Journal of Practical Hepatology, 2023, 26(6): 891-894.

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ICIs联合TKIs治疗HBV相关肝细胞癌患者疗效研究^*

Should the patients with advanced hepatocellular carcinoma get benefits from immunocheckpoint inhibitors and tyrosine kinase inhibitor combination therapy?

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