Department of Gastroenterology and Hepatology, AKH & Medizinische Universität Wien, Austria.
Aliment Pharmacol Ther. 2011 Oct;34(8):949-59. doi: 10.1111/j.1365-2036.2011.04823.x. Epub 2011 Aug 24.
Sorafenib is the new reference standard for patients with advanced hepatocellular carcinoma (HCC).
To identify prognostic factors in sorafenib-treated HCC patients and to evaluate outcomes with respect to liver function.
In this retrospective study, 148 HCC patients received sorafenib 400 mg b.d. across 11 Austrian institutions. Seventy-eight HCC patients who received best supportive care (BSC) in the pre-sorafenib era served as a control.
In sorafenib-treated patients, low baseline α-fetoprotein, low Child-Pugh (CP) score, compensated cirrhosis, and low baseline aspartate aminotransferase (AST) were associated with significantly longer overall survival (OS) on univariate analysis. CP score and baseline AST remained independent prognostic factors on multivariate analysis. In patients with Barcelona Clinic liver Cancer (BCLC) stage B or C HCC (sorafenib: n = 139; BSC: n = 39), CP-A patients had a median OS of 11.3 (sorafenib [n = 76]) vs. 6.4 (BSC [n = 17]) months (P = 0.010), and CP-B patients had a median OS of 5.5 (sorafenib [n = 55]) vs. 1.9 (BSC [n = 22]) months (P = 0.021). In the sorafenib group, median OS according to baseline AST was 11.8 (<100 U/L [n = 58]) vs. 3.9 (≥100 U/L [n = 15]) months for CP-A patients (P = 0.127), and 6.5 (<100 U/L [n = 33]) vs. 2.1 (≥100 U/L [n = 21]) months for CP-B patients (P = 0.011). There was no survival difference between sorafenib and BSC in patients with BCLC stage D HCC (1.5 vs. 1.4 months; P = 0.116).
Sorafenib was associated with improved survival in both CP-A and CP-B patients. In CP-B patients, baseline AST may be helpful in determining which patients are most likely to benefit from sorafenib.
索拉非尼是晚期肝细胞癌(HCC)患者的新标准治疗药物。
确定接受索拉非尼治疗的 HCC 患者的预后因素,并评估肝功能相关的治疗结果。
本回顾性研究纳入了 148 例在奥地利 11 家机构接受索拉非尼 400mg 每日两次治疗的 HCC 患者。78 例在索拉非尼治疗前接受最佳支持治疗(BSC)的 HCC 患者作为对照。
在接受索拉非尼治疗的患者中,较低的基线甲胎蛋白(AFP)、较低的 Child-Pugh(CP)评分、代偿性肝硬化和较低的基线天冬氨酸氨基转移酶(AST)与单因素分析中总生存期(OS)显著延长相关。CP 评分和基线 AST 在多因素分析中仍然是独立的预后因素。在巴塞罗那临床肝癌(BCLC)分期 B 或 C 的 HCC 患者(索拉非尼:n = 139;BSC:n = 39)中,CP-A 患者的中位 OS 为 11.3 个月(索拉非尼 [n = 76]) vs. 6.4 个月(BSC [n = 17])(P = 0.010),CP-B 患者的中位 OS 为 5.5 个月(索拉非尼 [n = 55]) vs. 1.9 个月(BSC [n = 22])(P = 0.021)。在索拉非尼组中,根据基线 AST 的中位 OS 为:CP-A 患者中,AST<100U/L(n = 58)为 11.8 个月 vs. AST≥100U/L(n = 15)为 3.9 个月(P = 0.127);CP-B 患者中,AST<100U/L(n = 33)为 6.5 个月 vs. AST≥100U/L(n = 21)为 2.1 个月(P = 0.011)。在 BCLC 分期 D 的 HCC 患者中,索拉非尼与 BSC 之间的生存无差异(1.5 个月 vs. 1.4 个月;P = 0.116)。
索拉非尼治疗可改善 CP-A 和 CP-B 患者的生存。在 CP-B 患者中,基线 AST 可能有助于确定哪些患者最有可能从索拉非尼治疗中获益。