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

StephenW

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.

StephenW

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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