Huang Gang, Lau Wan Yee, Wang Zhen-Guang, Pan Ze-Ya, Yuan Sheng-Xian, Shen Feng, Zhou Wei-Ping, Wu Meng-Chao
*Eastern Hepatobiliary Surgery Hospital, National Innovation Alliance for Hepatitis & Liver Cancer, Shanghai, China; and †Faculty of Medicine, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong SAR, People's Republic of China.
Ann Surg. 2015 Jan;261(1):56-66. doi: 10.1097/SLA.0000000000000858.
A randomized controlled trial was conducted to find out whether antiviral therapy in patients with hepatitis B-related hepatocellular carcinoma (HCC) improves long-term survival after hepatic resection.
Despite advances in surgery and in multidisciplinary treatment, there is still no effective adjuvant treatment to prevent HCC recurrence after R0 resection for HCC. Whether antiviral therapy is useful in reducing postoperative HCC recurrence is unclear.
Between May 2007 and April 2008, patients who received R0 hepatic resection for HBV-related HCC were randomly assigned to receive no treatment (the control group, n = 100) or antiviral therapy (adefovir 10 mg/d, the antiviral group, n = 100).
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 85.0%, 50.3%, 46.1% and 84.0%, 37.9%, 27.1%, respectively. The corresponding overall survival rates for the 2 groups were 96.0%, 77.6%, 63.1% and 94.0%, 67.4%, 41.5%, respectively. The recurrence-free survival and overall survival for the antiviral group were significantly better than the control group (P = 0.026, P = 0.001). After adjusting for the confounding prognostic factors in a Cox model, the relative risks of recurrence and death for antiviral treatment were 0.651 [95% confidence interval (CI): 0.451-0.938; P = 0.021] and 0.420 (95% CI: 0.271-0.651; P < 0.001). Antiviral therapy was an independent protective factor of late tumor recurrence (HR = 0.348, 95% CI: 0.177-0.687; P = 0.002) but not of early tumor recurrence [hazard ratio (HR) = 0.949, 95% CI: 0.617-1.459; P = 0.810].
In patients with hepatitis B-related HCC, adefovir antiviral therapy reduced late HCC recurrence and significantly improved overall survival after R0 hepatic resection.
开展一项随机对照试验，以确定乙型肝炎相关肝细胞癌（HCC）患者接受抗病毒治疗是否能改善肝切除术后的长期生存率。
尽管手术和多学科治疗取得了进展，但对于HCC行R0切除术后，仍没有有效的辅助治疗来预防HCC复发。抗病毒治疗是否有助于降低术后HCC复发尚不清楚。
2007年5月至2008年4月期间，因HBV相关HCC接受R0肝切除的患者被随机分为不接受治疗组（对照组，n = 100）或抗病毒治疗组（阿德福韦10 mg/d，抗病毒组，n = 100）。
两组的基线临床、实验室和肿瘤特征具有可比性。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85.0%、50.3%、46.1%和84.0%、37.9%、27.1%。两组相应的总生存率分别为96.0%、77.6%、63.1%和94.0%、67.4%、41.5%。抗病毒组的无复发生存率和总生存率显著优于对照组（P = 0.026，P = 0.001）。在Cox模型中对混杂的预后因素进行校正后，抗病毒治疗的复发相对风险和死亡相对风险分别为0.651 [95%置信区间（CI）：0.451 - 0.938；P = 0.021]和0.420（95% CI：0.271 - 0.651；P < 0.001）。抗病毒治疗是晚期肿瘤复发的独立保护因素（HR = 0.348，95% CI：0.177 - 0.687；P = 0.002），但不是早期肿瘤复发的独立保护因素[风险比（HR） = 0.949，95% CI：0.617 - 1.459；P = 0.810]。
在乙型肝炎相关HCC患者中，阿德福韦抗病毒治疗降低了晚期HCC复发，并显著改善了R0肝切除术后的总生存率。
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