在真实世界的乙型肝炎病毒相关性肝细胞癌患者队列中，托

StephenW

Effectiveness and safety of toripalimab, camrelizumab, and sintilimab in a real-world cohort of hepatitis B virus associated hepatocellular carcinoma patients
Jinzhang Chen  1   2 , Xiaoyun Hu  1 , Qi Li  1   2 , Wencong Dai  1 , Xiao Cheng  1 , Wei Huang  3 , Wenxuan Yu  1 , Mian Chen  4 , Yabing Guo  1 , Guosheng Yuan  1
Affiliations
Affiliations

    1
    Department of Infectious Diseases and Hepatology Unitl, Southern Medical University, Guangzhou, China.
    2
    Department of Oncology, Nanfang Hospital, Southern Medical University, Guangzhou, China.
    3
    Department of Oncology, ShunDe Hospital, Southern Medical University, Guangzhou, China.
    4
    Transplant Immunology Laboratory, Churchill Hospital, Oxford University Hospitals NHS Foundation Trust, Old Road, Headington, Oxford, UK.

    PMID: 33241036 PMCID: PMC7576044 DOI: 10.21037/atm-20-6063

Abstract

Background: The clinical significance of programmed cell death protein-1 (PD-1)-targeted immunotherapy in Chinese patients is understudied. We thus aimed to evaluate the 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 analysed hepatitis B virus (HBV)-associated HCC patients treated with toripalimab, camrelizumab, or sintilimab in a retrospective single-center cohort from November 2018 to June 2020. 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 patients were finally included in the analysis: 23 were treated with toripalimab, 33 with camrelizumab, and 14 with sintilimab. The mean duration of follow-up was 44.7 (95% CI: 39.9-49.6) weeks and the mean cycles of PD-1 at cutoff were 8.3±8.0 for all patients. The ORR and DCR for the whole cohort were 30% and 72.9%, respectively. Overall, 25 (35.7%) patients had radiological disease progression and 10 (14.3%) patients died during follow-up. Median PFS, median TTP, and median OS had not yet been reached. Most frequent drug-related adverse events (AEs) were rash (27.1%), hypertension (18.6%), fatigue (17.1%), diarrhea (17.1%), paresthesia (15.7%), and nausea (15.7%).

Conclusions: Our findings suggest that (I) PD-1 targeted immunotherapy with toripalimab, camrelizumab, or sintilimab yielded a promising outcome in Chinese HBV patients with HCC and that (II) immunotherapy was well tolerated generally and had manageable side effects. This approach thus warrants further popularization and application in clinical practice.

Keywords: Hepatocellular carcinoma (HCC); anti-programmed cell death protein-1 antibody (anti-PD-1 antibody); camrelizumab; programmed death receptor-1; sintilimab; toripalimab.

2020 Annals of Translational Medicine. All rights reserved.

StephenW

在真实世界的乙型肝炎病毒相关性肝细胞癌患者队列中，托曲单抗，卡瑞珠单抗和西替利单抗的有效性和安全性
陈锦章1 2，胡小云1，齐立1 2，戴文聪1，肖成1，黄伟3，闻文轩1，陈棉4，郭亚兵1，郭胜元1
隶属关系
隶属关系

    1个
    南方医科大学传染病与肝病学教研室，广州
    2
    南方医科大学附属南方医院肿瘤科，广州
    3
    南方医科大学附属顺德医院肿瘤科，广州
    4
    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，旧路，海丁顿，英国牛津。

    PMID：33241036 PMCID：PMC7576044 DOI：10.21037 / atm-20-6063

抽象

背景：对中国患者中以程序性细胞死亡蛋白-1（PD-1）为靶标的免疫疗法的临床意义进行了研究。因此，我们旨在评估真实队列中的托普利单抗，卡雷珠单抗或西替利单抗的PD-1抑制剂对中国肝细胞癌（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2020年6月在托马利单抗，卡雷珠单抗或西非单抗治疗的乙肝病毒（HBV）相关的HCC患者。以客观缓解率（ORR），疾病控制率评估疗效（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：最终纳入分析的70例患者：23例接受托利帕单抗治疗，33例接受卡雷珠单抗治疗，14例接受西妥昔单抗治疗。所有患者的平均随访时间为44.7周（95％CI：39.9-49.6）周，PD-1截止时的平均周期为8.3±8.0。整个队列的ORR和DCR分别为30％和72.9％。总体而言，有25名（35.7％）的患者发生了放射疾病进展，有10名（14.3％）的患者在随访期间死亡。 PFS中位数，TTP中位数和OS中位数尚未达到。最常见的药物相关不良事件（AEs）为皮疹（27.1％），高血压（18.6％），疲劳（17.1％），腹泻（17.1％），感觉异常（15.7％）和恶心（15.7％）。

结论：我们的研究结果表明：（I）托曲单抗，卡雷珠单抗或西替利单抗的PD-1靶向免疫疗法在中国HBV肝癌患者中产生了可喜的结局，并且（II）免疫疗法普遍耐受性良好且副作用可控。因此，该方法保证了在临床实践中的进一步普及和应用。

关键字：肝细胞癌；抗程序性细胞死亡蛋白1抗体（anti-PD-1抗体）;卡米单抗程序性死亡受体-1；西替利单抗托利帕单抗。

2020年《转化医学年鉴》。版权所有。

StephenW

http://atm.amegroups.com/article/view/52206/html