基线HBV载量不会影响接受抗程序性细胞死亡1免疫疗法的肝细

StephenW

Baseline HBV Loads Do Not Affect the Prognosis of Patients with Hepatocellular Carcinoma Receiving Anti-Programmed Cell Death-1 Immunotherapy
Xuqi Sun #  1   2   3 , Dandan Hu #  1   2 , Zhoutian Yang  1   2 , Zheng Liu  3   4 , Juncheng Wang  1   2 , Jinbin Chen  1   2 , Li Xu  1   2 , Zhongguo Zhou  1   2 , Minshan Chen  1   2 , Yaojun Zhang  1   2
Affiliations
Affiliations

    1
    Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China; Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, People's Republic of China.
    2
    Department of Liver Surgery, Sun Yat-Sen University Cancer Center, Guangzhou 510060, People's Republic of China.
    3
    Zhongshan School of Medicine, Sun Yat-Sen University, Guangzhou 510060, People's Republic of China.
    4
    Department of Nuclear Medicine, The First Affiliated Hospital of Sun Yat-Sen University, Guangzhou 510080, People's Republic of China.

#
Contributed equally.

    PMID: 33294424 PMCID: PMC7718972 DOI: 10.2147/JHC.S278527

Free PMC article
Abstract

Background: A high hepatitis B virus (HBV) load is a common exclusion criterion in hepatocellular carcinoma (HCC) clinical trials for anti-programmed cell death (PD)-1 immunotherapy. However, the validity of this criterion is barely verified. This study aimed to evaluate the impact of baseline HBV DNA levels and antiviral therapy on the oncological outcomes and liver functions of patients with HCC receiving anti-PD-1 immunotherapy.

Methods: We reviewed HCC trials related to anti-PD-(L)1 immunotherapy and whether they ruled out patients with increased HBV loads on clinicaltrials.gov. Then, for this retrospective study, we enrolled 253 HCC patients treated with anti-PD-1 blockade in our institution. Baseline information was compared between patients with low and high HBV loads. Overall survival (OS) and progression-free survival (PFS) were compared, and univariate and multivariate analyses were applied to identify potential risk factors for oncological outcomes and hepatic impairment.

Results: Among 76 HCC clinical trials including 13,927 patients receiving anti-PD-(L)1 blockade, 41 (53.9%) excluded patients with relatively high baseline HBV loads. The PFS and OS did not differ significantly between patients with baseline HBV loads ≤ 2000 IU/mL and those with viral loads >2000 IU/mL (p=0.615 and 0.982). The incidence of hepatic impairment showed no association with the baseline HBV load (p=0.319). Patients receiving antiviral therapy had a better OS than those without antiviral therapy in the high baseline HBV load group (p= 0.001).

Conclusion: High HBV loads did not compromise the clinical outcomes of HCC patients receiving anti-PD-1 blockade. Antiviral therapy could improve the OS of HCC patients with high HBV loads.

Keywords: hepatitis B virus; hepatocellular carcinoma; immunotherapy; viral load.

© 2020 Sun et al.

StephenW

基线HBV载量不会影响接受抗程序性细胞死亡1免疫疗法的肝细胞癌患者的预后。
孙旭奇1 2 3，胡丹丹1 2，杨周天1 2，刘正3 4，王俊成1 2，陈金彬1 2，李旭1 2，周国国1 2，陈Min山1 2，张耀军1 2
隶属关系
隶属关系

    1个
    中山大学肿瘤防治中心，华南肿瘤学国家重点实验室；癌症医学协同创新中心，广州510060。
    2
    中山大学肿瘤防治中心肝外科，广东广州510060。
    3
    中山大学中山医学院，中国广州510060。
    4
    中山大学附属第一医院核医学科，广东广州510080。

＃
贡献均等。

    PMID：33294424 PMCID：PMC7718972 DOI：10.2147 / JHC.S278527

免费PMC文章
抽象

背景：乙肝病毒（HBV）高负荷是肝细胞癌（HCC）抗程序性细胞死亡（PD）-1免疫疗法临床试验中的常见排除标准。但是，该标准的有效性几乎未得到验证。这项研究旨在评估基线HBV DNA水平和抗病毒治疗对接受抗PD-1免疫治疗的HCC患者的肿瘤学结局和肝功能的影响。

方法：我们审查了与抗PD-（L）1免疫疗法有关的HCC试验，以及是否在Clinicaltrials.gov上排除了HBV负荷增加的患者。然后，在这项回顾性研究中，我们纳入了253例接受抗PD-1阻断治疗的HCC患者。在低和高HBV负荷患者之间比较了基线信息。比较了总生存期（OS）和无进展生存期（PFS），并应用了单因素和多因素分析来确定肿瘤结局和肝功能损害的潜在危险因素。

结果：在76项HCC临床试验中，包括接受抗PD-（L）1阻滞的13,927例患者中，有41例（53.9％）排除了基线HBV负荷较高的患者。基线HBV负荷≤2000 IU / mL的患者与病毒负荷> 2000 IU / mL的患者之间的PFS和OS没有显着差异（p = 0.615和0.982）。肝功能不全的发生与基线HBV负荷无关（p = 0.319）。在高基线HBV负荷组中，接受抗病毒治疗的患者的OS优于未接受抗病毒治疗的患者（p = 0.001）。

结论：高乙肝病毒载量不会影响接受抗PD-1阻断的HCC患者的临床结局。抗病毒治疗可以改善高HBV负荷的HCC患者的OS。

关键词：乙型肝炎病毒；肝细胞癌；免疫疗法病毒载量。

©2020 Sun等。

StephenW

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