肝动脉灌注化疗与索拉非尼单药治疗晚期肝细胞癌患者的比较。

Comparison of hepatic arterial infusion chemotherapy versus sorafenib monotherapy in patients with advanced hepatocellular carcinoma.

作者信息

Kawaoka Tomokazu, Aikata Hiroshi, Hyogo Hideyuki, Morio Reona, Morio Kei, Hatooka Masahiro, Fukuhara Takayuki, Kobayashi Tomoki, Naeshiro Noriaki, Miyaki Daisuke, Hiramatsu Akira, Imamura Michio, Kawakami Yoshiiku, Takahashi Shoichi, Waki Koji, Tsuji Keiji, Kohno Hirotaka, Kohno Hiroshi, Moriya Takashi, Chayama Kazuaki

机构信息

Department of Medicine and Molecular Science, Division of Frontier Medical Science, Hiroshima University, Hiroshima, Japan.

Hiroshima City Asa Hospital, Hiroshima, Japan.

出版信息

J Dig Dis. 2015 Sep;16(9):505-12. doi: 10.1111/1751-2980.12267.

DOI:10.1111/1751-2980.12267

PMID:26121102

Abstract

OBJECTIVES

Sorafenib is the standard treatment for advanced hepatocellular carcinoma (HCC) with distant metastasis, unresectable HCC, and those refractory to transcatheter arterial chemoembolization (TACE) or with macroscopic vascular invasion (MVI). The application of sorafenib has been approved by the Japanese Government-sponsored Medicare for unresectable HCC. In this retrospective cohort study we aimed to compare various aspects of HAIC with sorafenib in the treatment of Child-Pugh A patients with advanced HCC who were otherwise free of extrahepatic metastasis.

METHODS

Altogether 177 patients with advanced HCC at Child-Pugh class A who were free of extrahepatic metastasis were retrospectively enrolled. The patients were divided into the HAIC group (n = 136) and the sorafenib group (n = 41), and were followed up until their death or withdrawal of therapy. Responses to treatment and overall survival were determined and compared between the two groups.

RESULTS

The proportion of patients with complete response, partial response, stable disease and progressive disease were 5.9%, 25.0%, 40.4% and 21.3% in the HAIC and 2.4%, 2.4%, 43.9% and 41.5% in the sorafenib group, respectively. The response rate was higher in the HAIC group than in the sorafenib group (30.9% vs 4.8%). The median survival time was 10 months in both HAIC and sorafenib groups. In patients with macroscopic vascular invasion (MVI) by the case-control method, the response rate was higher in the HAIC group than in the sorafenib group. Overall survival was longer in the HAIC group than in the sorafenib group (14 months vs 7 months, P = 0.005). Multivariate analysis identified MVI (hazard ratio 2.4, P = 0.018) as an independent prognostic factor of survival in the sorafenib group.

CONCLUSIONS

Response rate to HAIC was higher than that to sorafenib monotherapy. Prognosis was favorable in HAIC responders despite MVI. HAIC might be a potential treatment option for advanced HCC without extrahepatic metastasis.

摘要

目的

索拉非尼是晚期肝细胞癌（HCC）伴远处转移、不可切除的HCC以及对经动脉化疗栓塞术（TACE）难治或伴有肉眼可见血管侵犯（MVI）患者的标准治疗药物。索拉非尼的应用已获日本政府资助的医保批准用于不可切除的HCC。在这项回顾性队列研究中，我们旨在比较肝动脉灌注化疗（HAIC）与索拉非尼在治疗无肝外转移的Child-Pugh A级晚期HCC患者方面的各个方面。

方法

回顾性纳入177例Child-Pugh A级、无肝外转移的晚期HCC患者。将患者分为HAIC组（n = 136）和索拉非尼组（n = 41），并随访至患者死亡或停止治疗。确定并比较两组的治疗反应和总生存期。

结果

HAIC组完全缓解、部分缓解、病情稳定和病情进展的患者比例分别为5.9%、25.0%、40.4%和21.3%，索拉非尼组分别为2.4%、2.4%、43.9%和41.5%。HAIC组的缓解率高于索拉非尼组（30.9%对4.8%）。HAIC组和索拉非尼组的中位生存时间均为10个月。在采用病例对照法的肉眼可见血管侵犯（MVI）患者中，HAIC组的缓解率高于索拉非尼组。HAIC组的总生存期长于索拉非尼组（14个月对7个月，P = 0.005）。多因素分析确定MVI（风险比2.4，P = 0.018）是索拉非尼组生存的独立预后因素。