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标题: 在真实世界的乙型肝炎病毒相关肝细胞癌患者队列中,托里 [打印本页]

作者: StephenW    时间: 2020-7-7 12:28     标题: 在真实世界的乙型肝炎病毒相关肝细胞癌患者队列中,托里

Effectiveness and Safety of Toripalimab, Camrelizumab and Sintilimab in a Real-World Cohort of Hepatitis B Virus Associated Hepatocellular Carcinoma Patients
Guosheng Yuan  1 , Xiaoyun Hu  1 , Qi Li  1 , Wencong Dai  1 , Xiao Cheng  1 , Pengfei Ying  1 , Wenxuan Yu  1 , Yabing Guo  1 , Mian Chen  2 , Jinzhang Chen  1
Affiliations
Affiliations

    1
    Department of Infectious Diseases and Hepatology Unit, Nanfang Hospital, Southern Medical University, Guangzhou, China.
    2
    Transplant Immunology Laboratory, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Old Road, Headington, Oxford, United Kingdom.

    PMID: 32627214 DOI: 10.1111/bcp.14452

Abstract

Aims: The investigation regarding the clinical significance of programmed cell death protein-1 (PD-1)-targeted immunotherapy in Chinese patients is rare. This study evaluated safety and efficacy of PD-1 inhibitors with Toripalimab, Camrelizumab or Sintilimab for Chinese Hepatocellular carcinoma (HCC) patients in a real-life cohort.

Methods: We analyzed HBV associated HCC patients treated with Toripalimab, Camrelizumab or Sintilimab in a retrospective single-center cohort from Nov 2018 to Dec 2019. Efficacy was evaluated with objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), time to tumor progression (TTP) and overall survival (OS). Safety data were also recorded.

Results: Seventy five patients were finally included in the analysis: 26 for Toripalimab, 33 for Camrelizumab, and 16 for Sintilimab. Mean duration of follow-up was 22.7 ± 12.6 weeks and the mean Cycles of PD-1 at cut-off were 4.8 ± 2.7 for all patients. The ORR and DCR for the whole cohort were 17.3% and 73.0%, respectively. Overall, 21 (28.0%) patients had radiological disease progression and 6 (8.0%) patients died during follow-up. Median PFS was 40.7 (95% CI, 34.7-46.7) weeks, median TTP was 45.7 (95% CI, 40.5-60.0) weeks, and median OS was 51.1 (95% CI, 46.4-55.9) weeks. Most frequent drug-related AEs were Rash (20.0%), Hypertension (16.0%), Fatigue (13.3%), Paraesthesia (13.3%), and Diarrhoea (10.7%).

Conclusions: Our findings suggest that: 1. PD-1-targeted immunotherapy with Toripalimab, Camrelizumab or Sintilimab yielded a promising outcome in Chinese HBV patients with HCC; 2. Immunotherapy was well tolerated generally and had manageable side effects, which is worth of popularization and application in clinical practice.

Keywords: anti-PD-1 antibody; camrelizumab; hepatocellular carcinoma; programmed death receptor-1; sintilimab; toripalimab.

This article is protected by copyright. All rights reserved.
作者: StephenW    时间: 2020-7-7 12:28

在真实世界的乙型肝炎病毒相关肝细胞癌患者队列中,托里帕单抗,卡雷珠单抗和辛替利单抗的有效性和安全性
袁国胜1,胡晓云1,齐立1,戴文聪1,肖成1,彭飞英1,于文轩1,郭亚兵1,陈勉2,陈锦章1
隶属关系
隶属关系

    1个
    南方医科大学南方医院传染病与肝病科,广东广州
    2
    牛津大学医院,丘吉尔医院,移植免疫学实验室,NHS基金会信托基金,老路,海德顿,英国牛津。

    PMID:32627214 DOI:10.1111 / bcp.14452

抽象

目的:关于针对中国患者的程序性细胞死亡蛋白-1(PD-1)靶向免疫疗法的临床意义的研究很少。这项研究评估了在现实生活中,帕妥拉单抗,托莫单抗或卡尼单抗或辛替利单抗对中国肝细胞癌(HCC)患者的安全性和疗效。

方法:我们回顾性分析了自2018年11月至2019年12月在托马利单抗,卡瑞珠单抗或辛替利单抗治疗的HBV相关肝癌患者的疗效,并评估了客观缓解率(ORR),疾病控制率(DCR),无进展生存期(PFS),肿瘤进展时间(TTP)和总体生存期(OS)。还记录了安全数据。

结果:最终有75名患者被纳入分析:托利帕单抗26例,卡雷珠单抗33例和辛替利单抗16例。所有患者的平均随访时间为22.7±12.6周,PD-1截止时的平均周期为4.8±2.7。整个队列的ORR和DCR分别为17.3%和73.0%。总体而言,有21例(28.0%)的患者有放射疾病进展,而6例(8.0%)的患者在随访期间死亡。 PFS中位数为40.7(95%CI,34.7-46.7)周,中位数TTP为45.7(95%CI,40.5-60.0)周,OS中位数为51.1(95%CI,46.4-55.9)周。最常见的药物相关不良事件是皮疹(20.0%),高血压(16.0%),疲劳(13.3%),感觉异常(13.3%)和腹泻(10.7%)。

结论:我们的发现表明:1.在中国的HCC HBV患者中,以托列单抗,卡瑞珠单抗或辛替利单抗进行PD-1靶向免疫治疗取得了可喜的结果; 2.免疫疗法总体耐受性好,副作用可控,值得在临床实践中推广应用。

关键词:抗PD-1抗体;卡米单抗肝细胞癌;程序性死亡受体-1;西替利单抗托利帕单抗。

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