Departments of *Hepatobiliary Surgery †Pharmacy, The First Affiliated Hospital of Chongqing Medical University ‡Department of Hepatobiliary Surgery, Peoples' Hospital of Changshou District, Chongqing, China.
J Clin Gastroenterol. 2013 Nov-Dec;47(10):871-80. doi: 10.1097/MCG.0b013e3182a87cfd.
Several studies have demonstrated that sorafenib is effective in the treatment of unresectable hepatocellular carcinoma (HCC). We performed a systematic review of the efficacy and safety of sorafenib in Child-Pugh A patients with unresectable HCC. The value of sorafenib treatment in different subgroups was examined.
A search of the literature published up to July 2012 was conducted. Pubmed, Embase, and the Cochrane library were searched and only randomized controlled trials were included.
Five randomized controlled trials consisting of 1462 patients with unresectable HCC were included. Meta-analyses demonstrated that sorafenib improved the control rate of the disease [relative risk, 1.85; 95% confidence interval (CI), 1.55, 2.20; P<0.001], decreased the risk for tumor progression (hazard ratios, 0.61; 95% CI, 0.51, 0.73; P<0.001), and decreased mortality (hazard ratios, 0.71; 95% CI, 0.56, 0.89; P<0.001), relative to placebo. Subgroup analyses indicated that sorafenib-based treatments were effective in unresectable HCC regardless of the etiology, performance status, Barcelona Clinic Liver Cancer-stage, alanine transaminase/asparate transaminase, bilirubin, and α-feto protein level, except in the subgroup of prior local therapy. Sorafenib was associated with a higher risk of adverse effects than placebo. The risk for grade 3-4 hand-foot skin reactions, rash or desquamation, diarrhea, and hypertension was much higher in the sorafenib treatment group. These side effects could often be mitigated with appropriate treatment.
Sorafenib was a moderately effective and safe oral drug for use in Child-Pugh A patients with unresectable HCC. Sorafenib monotherapy is not recommended for treating intermediate-stage HCC. More research is needed on the efficacy of sorafenib treatment in patients with prior local therapy.
几项研究表明索拉非尼对不可切除的肝细胞癌（HCC）的治疗有效。我们对索拉非尼在不可切除 HCC 的 Child-Pugh A 患者中的疗效和安全性进行了系统评价。检查了索拉非尼治疗不同亚组的价值。
对截至 2012 年 7 月发表的文献进行了检索。检索了 Pubmed、Embase 和 Cochrane 图书馆，仅纳入随机对照试验。
纳入了 5 项包含 1462 例不可切除 HCC 患者的随机对照试验。Meta 分析表明，索拉非尼提高了疾病控制率[相对风险，1.85；95%置信区间（CI），1.55，2.20；P<0.001]，降低了肿瘤进展风险（风险比，0.61；95%CI，0.51，0.73；P<0.001），并降低了死亡率（风险比，0.71；95%CI，0.56，0.89；P<0.001），与安慰剂相比。亚组分析表明，索拉非尼治疗对不可切除的 HCC 有效，无论病因、表现状态、巴塞罗那临床肝癌分期、丙氨酸转氨酶/天冬氨酸转氨酶、胆红素和α-胎蛋白水平如何，除了既往局部治疗亚组。索拉非尼的不良反应风险高于安慰剂。索拉非尼治疗组的手足皮肤反应、皮疹或脱屑、腹泻和高血压的 3-4 级发生率明显更高。这些副作用通常可以通过适当的治疗来减轻。
索拉非尼是一种对不可切除的 Child-Pugh A 型 HCC 患者具有中等疗效和安全性的口服药物。索拉非尼单药治疗不推荐用于治疗中晚期 HCC。需要进一步研究索拉非尼治疗既往局部治疗患者的疗效。
