Nakano Masahito, Niizeki Takashi, Nagamatsu Hiroaki, Tanaka Masatoshi, Kuromatsu Ryoko, Satani Manabu, Okamura Shusuke, Iwamoto Hideki, Shimose Shigeo, Shirono Tomotake, Noda Yu, Koga Hironori, Torimura Takuji
Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Fukuoka 830-0011, Japan.
Division of Gastroenterology, Department of Medicine, Yame General Hospital, Yame, Fukuoka 834-0034, Japan.
Mol Clin Oncol. 2017 Dec;7(6):1013-1020. doi: 10.3892/mco.2017.1442. Epub 2017 Oct 4.
Although sorafenib and hepatic arterial infusion chemotherapy (HAIC) have been proven to improve prognosis in hepatocellular carcinoma (HCC) patients with macroscopic vascular invasion (MVI), the most appropriate approach remains unclear. The present multicenter, non-randomized, prospective cohort study aimed to compare the efficacy and safety of HAIC and sorafenib in patients with advanced HCC and MVI, without extra-hepatic spread (EHS) and Child-Pugh class A disease. The present study was performed between April 2008 and March 2014, and 64 HCC patients with MVI, without EHS and Child-Pugh class A disease were registered. Of these patients, 44 were treated with HAIC and 20 with sorafenib. HAIC involved cisplatin (50 mg fine powder in 5-10 ml lipiodol) and a continuous infusion of 5-fluorouracil (FU) (1,500 mg/5 days), which is referred to as new 5-FU and cisplatin therapy (NFP). The primary outcome was progression-free survival, and the secondary outcome was overall survival (OS). Clinical factors influencing OS and the therapeutic effect were identified using univariate and multivariate analyses. There were no differences in clinical factors between the two groups. The median progression-free survival was 5.1 and 9.5 months in the sorafenib and NFP groups, respectively (P=0.001). The complete response (CR) or partial response (PR) rates were 10 and 71% in the sorafenib and NFP groups, respectively (P<0.001). The median OS in the sorafenib and NFP groups was 13.2 and 30.4 months, respectively (P=0.013). Multivariate analysis revealed that the independent predictors of survival were Child-Pugh score (5, P=0.022, 95% CI, 0.191-0.892), grade of portal vein invasion (brunch, P=0.009, 95% CI, 0.220-0.752), and therapeutic effect (CR or PR, P<0.001, 95% CI, 0.220-0.752), and the independent predictor of therapeutic effect was therapeutic regimen (NFP, P<0.001, 95% CI, 0.006-0.199). NFP should be the first choice for patients with advanced HCC and MVI, without EHS and Child-Pugh A disease.
尽管索拉非尼和肝动脉灌注化疗（HAIC）已被证明可改善伴有肉眼可见血管侵犯（MVI）的肝细胞癌（HCC）患者的预后，但最合适的治疗方法仍不明确。本多中心、非随机、前瞻性队列研究旨在比较HAIC与索拉非尼在无肝外转移（EHS）且Child-Pugh A级的晚期HCC合并MVI患者中的疗效和安全性。本研究于2008年4月至2014年3月进行，登记了64例无EHS且Child-Pugh A级的HCC合并MVI患者。其中，44例接受HAIC治疗，20例接受索拉非尼治疗。HAIC采用顺铂（50mg细粉溶于5 - 10ml碘油）及持续输注5-氟尿嘧啶（FU）（1500mg/5天），即新5-FU和顺铂疗法（NFP）。主要结局为无进展生存期，次要结局为总生存期（OS）。采用单因素和多因素分析确定影响OS和治疗效果的临床因素。两组临床因素无差异。索拉非尼组和NFP组的中位无进展生存期分别为5.1个月和9.5个月（P = 0.001）。索拉非尼组和NFP组的完全缓解（CR）或部分缓解（PR）率分别为10%和71%（P < 0.001）。索拉非尼组和NFP组的中位OS分别为13.2个月和30.4个月（P = 0.013）。多因素分析显示，生存的独立预测因素为Child-Pugh评分（5，P = 0.022，95%CI，0.191 - 0.892）、门静脉侵犯程度（分支，P = 0.009，95%CI，0.220 - 0.752）和治疗效果（CR或PR，P < 0.001，95%CI，0.220 - 0.752），治疗效果的独立预测因素为治疗方案（NFP，P < 0.001，95%CI，0.006 - 0.199）。对于无EHS且Child-Pugh A级的晚期HCC合并MVI患者，NFP应作为首选治疗方案。
