Huang Yonghui, Chen Bin, Liu Ni, Li Nan, Dao Haitao, Chen Wei, Yang Jianyong
Int J Clin Pharmacol Ther. 2017 Jun;55(6):498-508. doi: 10.5414/CP202787.
Barcelona clinic liver cancer (BCLC) stage B hepatocellular carcinoma (HCC) is a heterogeneous disease group. Transarterial chemoembolization (TACE) is indicated for BCLC stage B HCC, while sorafenib is indicated for BCLC stage C HCC. This study aimed to evaluate the efficacy of TACE+sorafenib compared with TACE monotherapy in the treatment of BCLC stage B HCC.
Patients with BCLC stage B unresectable HCC.
This was a retrospective study in patients with BCLC stage B HCC who received TACE (n = 144) or TACE+sorafenib (n = 46) between January 2008 and January 2014. Child-Pugh classification, history of hepatitis or cirrhosis, nodule number, tumor vascularity, ECOG performance status, adverse events, and survival were evaluated. Patients were matched 1 : 1 using the propensity score approach.
Median overall survival (OS) was 18.0 months in the TACE+sorafenib group compared with 10.0 months for TACE (p = 0.002). In matched patients, multivariate analysis showed that the use of TACE+sorafenib (HR = 0.351, 95%CI: 0.215-0.574, p < 0.001) and multiple-diffuse nodules (HR = 0.497, 95% CI: 0.293 - 0.884, p = 0.010) were independently associated with a better prognosis. Subgroup analysis showed survival benefits for patients with Child-Pugh A classification (p = 0.001), cirrhosis (p = 0.001), hepatitis B (p < 0.001), hypovascular lesion (p = 0.001), and both single/multiple nodules p = 0.001). Cumulative rates of adverse events were similar between the two groups (p = 0.155), but hand-foot syndrome (58.7% vs. 12.5%, p < 0.001) and diarrhea (60.9% vs. 40.3%, p = 0.02) were more frequent in the TACE+sorafenib group.
CONCLUSIONS: The combination of TACE+sorafenib might improve the OS of patients with BCLC stage B HCC. These results also suggest that some subsets of patients could benefit more from the TACE+sorafenib combination. .
巴塞罗那临床肝癌(BCLC)分期为B期的肝细胞癌(HCC)是一组异质性疾病。经动脉化疗栓塞术(TACE)适用于BCLC分期为B期的HCC,而索拉非尼适用于BCLC分期为C期的HCC。本研究旨在评估TACE联合索拉非尼与单纯TACE治疗BCLC分期为B期HCC的疗效。
BCLC分期为B期不可切除HCC患者。
这是一项回顾性研究,研究对象为2008年1月至2014年1月期间接受TACE(n = 144)或TACE联合索拉非尼(n = 46)治疗的BCLC分期为B期的HCC患者。评估了Child-Pugh分级、肝炎或肝硬化病史、结节数量、肿瘤血管情况、美国东部肿瘤协作组(ECOG)体能状态、不良事件和生存率。采用倾向评分法对患者进行1:1匹配。
TACE联合索拉非尼组的中位总生存期(OS)为18.0个月,而TACE组为10.0个月(p = 0.002)。在匹配患者中,多因素分析显示,使用TACE联合索拉非尼(风险比[HR] = 0.351,95%置信区间[CI]:0.215 - 0.574,p < 0.001)和多发弥漫性结节(HR = 0.497,95% CI:0.293 - 0.884,p = 0.010)与较好的预后独立相关。亚组分析显示,Child-Pugh A分级(p = 0.001)、肝硬化(p = 0.001)、乙型肝炎(p < 0.001)、乏血供病变(p = 0.001)以及单发/多发结节患者(p = 0.001)从TACE联合索拉非尼治疗中均有生存获益。两组不良事件的累积发生率相似(p = 0.155),但TACE联合索拉非尼组的手足综合征(58.7% vs. 12.5%,p < 0.001)和腹泻(60.9% vs. 40.3%,p = 0.02)更为常见。
TACE联合索拉非尼可能改善BCLC分期为B期HCC患者的总生存期。这些结果还表明,部分亚组患者可能从TACE联合索拉非尼治疗中获益更多。