奥沙利铂联合氟尿嘧啶/亚叶酸肝动脉灌注化疗对比索拉非尼治疗晚期肝细胞癌

Hepatic arterial infusion of oxaliplatin plus fluorouracil/leucovorin vs. sorafenib for advanced hepatocellular carcinoma.

机构信息

Minimally Invasive Interventional Division, Department of Medical Imaging and Interventional Radiology, Sun Yat-sen University Cancer Center, Guangzhou, China.

State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, China.

出版信息

J Hepatol. 2018 Jul;69(1):60-69. doi: 10.1016/j.jhep.2018.02.008. Epub 2018 Feb 20.

DOI:10.1016/j.jhep.2018.02.008

PMID:29471013

Abstract

BACKGROUND & AIMS: To compare the overall survival (OS) and disease progression free survival (PFS) in patients with advanced hepatocellular carcinoma (Ad-HCC) who are undergoing hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment vs. sorafenib.

METHODS

This retrospective study was approved by the ethical review committee, and informed consent was obtained from all patients before treatment. HAI of FOLFOX (HAIF) was recommended as an alternative treatment option for patients who refused sorafenib. Of the 412 patients with Ad-HCC (376 men and 36 women) between Jan 2012 to Dec 2015, 232 patients were treated with sorafenib; 180 patients were given HAIF therapy. The median age was 51 years (range, 16-82 years). Propensity-score matched estimates were used to reduce bias when evaluating survival. Survival curves were calculated by performing the Kaplan-Meier method and compared by using the log-rank test and Cox regression models.

RESULTS

The median PFS and OS in the HAIF group were significantly longer than those in the sorafenib group (PFS 7.1 vs. 3.3 months [RECIST]/7.4 vs. 3.6 months [mRECIST], respectively; OS 14.5 vs. 7.0 months; p <0.001 for each). In the propensity-score matched cohorts (147 pairs), both PFS and OS in the HAIF group were longer than those in the sorafenib group (p <0.001). At multivariate analysis, HAIF treatment was an independent factor for PFS (hazard ratio [HR] 0.389 [RECIST]/0.402 [mRECIST]; p <0.001 for each) and OS (HR 0.129; p <0.001).

CONCLUSION

HAIF therapy may improve survival compared to sorafenib in patients with Ad-HCC. A prospective randomized trial is ongoing to confirm this finding.

LAY SUMMARY

We compared the hepatic arterial infusion of FOLFOX (a combination chemotherapy) with sorafenib (a tyrosine kinase inhibitor) in patients with advanced hepatocellular carcinoma, retrospectively. It was found that hepatic arterial infusion of FOLFOX therapy may improve both progression free and overall survival in patients with advanced hepatocellular carcinoma.

摘要

背景与目的

比较接受奥沙利铂氟尿嘧啶/亚叶酸（FOLFOX）肝动脉灌注（HAI）治疗与索拉非尼治疗的晚期肝细胞癌（Ad-HCC）患者的总生存期（OS）和无疾病进展生存期（PFS）。

方法

本回顾性研究获得了伦理审查委员会的批准，并在治疗前获得了所有患者的知情同意。对于拒绝索拉非尼的患者，建议将 FOLFOX 的 HAI（HAIF）作为替代治疗选择。在 2012 年 1 月至 2015 年 12 月期间，共有 412 例 Ad-HCC 患者（376 名男性和 36 名女性），其中 232 例接受索拉非尼治疗，180 例接受 HAIF 治疗。中位年龄为 51 岁（范围 16-82 岁）。使用倾向评分匹配估计来减少评估生存时的偏差。通过Kaplan-Meier 方法计算生存曲线，并通过对数秩检验和 Cox 回归模型进行比较。

结果

HAIF 组的中位 PFS 和 OS 明显长于索拉非尼组（RECIST 标准下的 PFS 为 7.1 个月 vs. 3.3 个月，mRECIST 标准下的 PFS 为 7.4 个月 vs. 3.6 个月；OS 为 14.5 个月 vs. 7.0 个月；每个标准均 p<0.001）。在倾向评分匹配的队列中（147 对），HAIF 组的 PFS 和 OS 均长于索拉非尼组（p<0.001）。多变量分析显示，HAIF 治疗是 PFS（风险比 [HR] 0.389 [RECIST] / 0.402 [mRECIST]；每个标准均 p<0.001）和 OS（HR 0.129；p<0.001）的独立因素。