接受PD-1抑製劑並同時預防病毒的高HBV-DNA和低HBV-DNA負荷患者

StephenW

Comparison of HBV reactivation between patients with high HBV-DNA and low HBV-DNA loads undergoing PD-1 inhibitor and concurrent antiviral prophylaxis
Min-Ke He #  1 , Chuan Peng #  2 , Yang Zhao #  1 , Run-Bin Liang #  1 , Zhi-Cheng Lai  1 , Anna Kan  1 , Qi-Jiong Li  1 , Wei Wei  1 , Yao-Jun Zhang  1 , Min-Shan Chen  1 , Rong-Ping Guo  1 , Ming Shi  3
Affiliations
Affiliations

    1
    Department of Hepatobiliary Oncology, 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 Ultrasonography, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.
    3
    Department of Hepatobiliary Oncology, 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. [email protected].

#
Contributed equally.

    PMID: 33813646 DOI: 10.1007/s00262-021-02911-w

Abstract

Background: Programmed cell death protein-1 (PD-1) inhibitor is recommended to treat advanced hepatocellular carcinoma (HCC). However, the safety of PD-1 inhibitor in patients with high HBV-DNA load is unknown because of the potential risk of hepatitis B virus (HBV) reactivation. This study was to compare the HBV reactivation between patients with low HBV-DNA loads and high HBV-DNA loads undergoing antiviral prophylaxis and PD-1 inhibitor.

Methods: This was a retrospective study including consecutive hepatitis B surface antigen-positive HCC patients who received PD-1 inhibitor and concurrent antiviral prophylaxis for prevention of clinical hepatitis. Patients were divided into low HBV-DNA group (low group, ≤ 500 IU/ml) and high HBV-DNA group (high group, > 500 IU/ml) according to the baseline HBV-DNA level. The incidences of HBV reactivation, HBV-associated hepatitis, and PD-1 inhibitor disruption were compared between the two groups.

Results: Two hundred two eligible patients were included: 94 in the low group and 108 in the high group. Seven patients (5 in the low group and 2 in the high group) developed HBV reactivation, and all recovered from HBV reactivation and HBV-associated hepatitis. The incidence of HBV reactivation in the two groups was low (5.3% vs 1.9%, P = 0.34). There was also no difference in the incidence of HBV-associated hepatitis (P = 0.56), or PD-1 inhibitor disruption (P = 0.82). The multivariable analysis showed PD-1 inhibitor with hepatic arterial infusion chemotherapy was the only significant risk factor for HBV reactivation (P = 0.04) and hepatitis (P = 0.002).

Conclusion: With concurrent antiviral prophylaxis, HBV-DNA load higher than 500 IU/ml should not be a contraindication for PD-1 inhibitor.

Keywords: Antiviral prophylaxis; Hepatic arterial infusion chemotherapy; Hepatitis B virus reactivation; Hepatocellular carcinoma; Programmed cell death protein-1 inhibitor.

StephenW

接受PD-1抑製劑並同時預防病毒的高HBV-DNA和低HBV-DNA負荷患者的HBV活化
何敏克＃1，川鵬＃2，楊昭＃1，梁潤斌＃1，賴志成1，安娜安娜1，李啟瓊1，魏薇1，張耀軍1，陳敏珊1郭榮平1明師3
隸屬關係
隸屬關係

    1個
    中山大學腫瘤學中心肝膽腫瘤科，華南腫瘤學國家重點實驗室，腫瘤醫學協同創新中心，中國廣州510060。
    2個
    中山大學腫瘤學中心超聲科，華南腫瘤學國家重點實驗室，腫瘤醫學協同創新中心，中國廣州。
    3
    中山大學腫瘤學中心肝膽腫瘤科，華南腫瘤學國家重點實驗室，腫瘤醫學協同創新中心，中國廣州510060。 [email protected]。

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貢獻均等。

    PMID：33813646 DOI：10.1007 / s00262-021-02911-w

抽象的

背景：推薦使用程序性細胞死亡蛋白1（PD-1）抑製劑治療晚期肝細胞癌（HCC）。然而，由於乙型肝炎病毒（HBV）再次激活的潛在風險，因此尚不清楚PD-1抑製劑在高HBV-DNA負荷患者中的安全性。這項研究旨在比較接受抗病毒預防和PD-1抑製劑的低HBV-DNA負荷和高HBV-DNA負荷患者的HBV活化。

方法：這是一項回顧性研究，包括連續接受PD-1抑製劑的乙型肝炎表面抗原陽性的HCC患者，同時進行了抗病毒藥物的預防，以預防臨床肝炎。根據基線HBV-DNA水平，將患者分為低HBV-DNA組（低組，≤500 IU / ml）和高HBV-DNA組（高組，> 500 IU / ml）。比較了兩組的HBV激活，HBV相關肝炎和PD-1抑製劑破壞的發生率。

結果：包括222名符合條件的患者：低組94例，高組108例。七名患者（低組5例，高組2例）發生了HBV激活，並且全部從HBV激活和HBV相關肝炎中康復。兩組的HBV再激活發生率較低（5.3％比1.9％，P = 0.34）。 HBV相關肝炎（P = 0.56）或PD-1抑製劑破壞（P = 0.82）的發生率也沒有差異。多變量分析顯示，PD-1抑製劑與肝動脈灌注化療是HBV激活（P = 0.04）和肝炎（P = 0.002）的唯一重要危險因素。

結論：同時進行抗病毒預防，HBV-DNA負荷高於500 IU / ml不應作為PD-1抑製劑的禁忌證。

關鍵詞：預防病毒；肝動脈灌注化療；乙型肝炎病毒重新激活；肝細胞癌；程序性細胞死亡蛋白1抑製劑。

挚友888888

现在医生都推荐靶向药和PD1，如果使用这些药以后，后面的治疗路还有吗？还有多少人起作用，有数据或文章吗？能否让我们战友们阅读，可以少走弯路，谢谢！