Section of Gastroenterology, DI.BI.M.I.S., Palermo, Italy.
Unit of Infectious Diseases and Hepatology, Teaching Hospital-University of Parma, Italy.
Liver Int. 2017 Aug;37(8):1157-1166. doi: 10.1111/liv.13357. Epub 2017 Feb 1.
BACKGROUND & AIMS: Determining risk for recurrence or survival after curative resection or ablation in patients with hepatitis C virus (HCV)-related hepatocellular carcinoma (HCC) is important for stratifying patients according to expected outcomes in future studies of adjuvant therapy in the era of direct-acting antivirals (DAAs). The aims of this meta-analysis were to estimate the recurrence and survival probabilities of HCV-related early HCC following complete response after potentially curative treatment and to identify predictors of recurrence and survival.
Studies reporting time-dependent outcomes (HCC recurrence or death) after potentially curative treatment of HCV-related early HCC were identified in MEDLINE through May 2016. Data on patient populations and outcomes were extracted from each study by three independent observers and combined using a distribution-free summary survival curve. Primary outcomes were actuarial probabilities of recurrence and survival.
Eleven studies met the inclusion criteria. Pooled estimates of actuarial recurrence rates were 7.4% at 6 months and 47.0% at 2 years. Pooled estimates of actuarial survival rates were 79.8% at 3 years and 58.6% at 5 years. Heterogeneity among studies was highly significant for all outcomes. By univariate meta-regression analyses, lower serum albumin, randomized controlled trial study design and follow-up were independently associated with higher recurrence risk, whereas tumour size and alpha-foetoprotein levels were associated with higher mortality.
This meta-analysis showed that recurrence risk and survival are extremely variable in patients with successfully treated HCV-related HCC, providing a useful benchmark for indirect comparisons of the benefits of DAAs and for a correct design of randomized controlled trials in the adjuvant setting.
在丙型肝炎病毒(HCV)相关肝细胞癌(HCC)患者中,确定根治性切除或消融后复发或生存的风险对于根据直接作用抗病毒药物(DAA)时代辅助治疗的预期结果对患者进行分层非常重要。本荟萃分析的目的是估计完全缓解后 HCV 相关早期 HCC 根治性治疗后的复发和生存概率,并确定复发和生存的预测因素。
通过 2016 年 5 月的 MEDLINE 检索,确定了报告潜在根治性治疗后 HCV 相关早期 HCC 时间依赖性结局(HCC 复发或死亡)的研究。三位独立观察者从每项研究中提取患者人群和结局的数据,并使用无分布汇总生存曲线进行组合。主要结局是复发性和生存的实际概率。
11 项研究符合纳入标准。荟萃分析的 6 个月和 2 年的实际复发率分别为 7.4%和 47.0%。荟萃分析的 3 年和 5 年的实际生存率分别为 79.8%和 58.6%。所有结局的研究间异质性均高度显著。通过单变量荟萃回归分析,血清白蛋白较低、随机对照试验设计和随访与较高的复发风险独立相关,而肿瘤大小和甲胎蛋白水平与较高的死亡率相关。
本荟萃分析显示,成功治疗的 HCV 相关 HCC 患者的复发风险和生存情况差异极大,为 DAA 的间接比较以及辅助治疗中正确设计随机对照试验提供了有用的基准。