Eastern Hepatobiliary Surgery Hospital, National Innovation Alliance for Hepatitis and Liver Cancer, Shanghai, China.
Faculty of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong SAR, People's Republic of China.
Ann Surg. 2018 Dec;268(6):943-954. doi: 10.1097/SLA.0000000000002727.
Despite antiviral treatment has been shown to reduce hepatocellular carcinoma (HCC) recurrence after curative treatment for hepatitis B virus (HBV)-related HCC in patients with high preoperative HBV-DNA levels, it is still unclear whether antiviral therapy is useful in reducing recurrence in patients with low preoperative HBV-DNA levels.
In this randomized controlled trial, 200 patients who underwent curative resection for HCC with low baseline HBV-DNA levels were randomly assigned to receive preemptive antiviral therapy or not. The primary endpoints were recurrence-free survival. This study was censored on March 31, 2015 when all surviving patients had a minimum follow-up of 60 months. The analysis was done on an intention-to-treat basis.
The baseline clinical, laboratory, and tumor characteristics of the 2 groups were comparable. The 1-, 3-, and 5-year recurrence-free survival rates for the antiviral group and the control group were 85.9%, 55.2%, and 52.0% and 80.6%, 40.9%, and 32.3%, respectively. The corresponding overall survival rates for the 2 groups were 94.0%, 75.7%, and 64.1% and 90.0%, 62.4%, and 43.7%, respectively. The recurrence-free survival and overall survival for the antiviral group were significantly better than the control group (P = 0.016, P = 0.004, respectively). After adjusting for confounding prognostic factors in a Cox model, the relative risks of recurrence and death for antiviral treatment were 0.601 [95% confidence interval (CI), 0.409-0.884; P = 0.010] and 0.509 (95% CI, 0.333-0.778; P = 0.002), respectively. Antiviral therapy was an independent protective factor of late tumor recurrence (hazard ratio [HR] = 0.316, 95% CI 0.157-0.637; P = 0.001) but not of early tumor recurrence (HR = 0.782, 95% CI, 0.493-1.240; P = 0.296).
In patients with low preoperative HBV-DNA levels, antiviral therapy significantly reduced HCC recurrence after R0 hepatic resection.
尽管抗病毒治疗已被证明可降低术前 HBV-DNA 水平较高的乙型肝炎病毒（HBV）相关 HCC 患者根治性治疗后的肝细胞癌（HCC）复发率，但抗病毒治疗是否可降低术前 HBV-DNA 水平较低的患者的复发率仍不清楚。
在这项随机对照试验中，200 例接受 HCC 根治性切除术且基线 HBV-DNA 水平较低的患者被随机分配接受或不接受预防性抗病毒治疗。主要终点是无复发生存率。本研究于 2015 年 3 月 31 日截止，所有存活患者的随访时间均至少为 60 个月。分析基于意向治疗原则进行。
两组的基线临床、实验室和肿瘤特征相当。抗病毒组和对照组的 1 年、3 年和 5 年无复发生存率分别为 85.9%、55.2%和 52.0%和 80.6%、40.9%和 32.3%。两组的总生存率分别为 94.0%、75.7%和 64.1%和 90.0%、62.4%和 43.7%。抗病毒组的无复发生存率和总生存率明显优于对照组（P=0.016，P=0.004）。在 Cox 模型中调整混杂预后因素后，抗病毒治疗的复发和死亡风险比分别为 0.601（95%置信区间[CI]，0.409-0.884；P=0.010）和 0.509（95%CI，0.333-0.778；P=0.002）。抗病毒治疗是晚期肿瘤复发的独立保护因素（风险比[HR] = 0.316，95%CI 0.157-0.637；P=0.001），但不是早期肿瘤复发的保护因素（HR = 0.782，95%CI，0.493-1.240；P=0.296）。
在术前 HBV-DNA 水平较低的患者中，抗病毒治疗可显著降低 R0 肝切除术后 HCC 的复发率。
