一线索拉非尼单药治疗失败的晚期肝细胞癌二线阿昔替尼的

StephenW

Oncologist. 2020 Apr 9. doi: 10.1634/theoncologist.2020-0143. [Epub ahead of print]
A Multicenter Phase II Study of Second-Line Axitinib for Patients with Advanced Hepatocellular Carcinoma Failing First-Line Sorafenib Monotherapy.
Lin ZZ1,2,3, Chen BB4, Hung YP5, Huang PH2, Shen YC1,2,6, Shao YY2,6, Hsu CH1,2,6, Cheng AL1,2,3,6, Lee RC7, Chao Y5,8, Hsu C1,2,6.
Author information

1
    Department of Medical Oncology, National Taiwan University Cancer Center, Taipei, Taiwan.
2
    Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.
3
    Department of Internal Medicine, National Taiwan University College of Medicine, Taipei, Taiwan.
4
    Department of Radiology, National Taiwan University Hospital, Taipei, Taiwan.
5
    Department of Oncology, Taipei Veterans General Hospital, Taipei, Taiwan.
6
    Graduate Institute of Oncology, National Taiwan University College of Medicine, Taipei, Taiwan.
7
    Department of Radiology, Taipei Veterans General Hospital, Taipei, Taiwan.
8
    School of Medicine, National Yang-Ming University, Taipei, Taiwan.

Abstract
LESSONS LEARNED:

For patients with advanced hepatocellular carcinoma after failure of first-line sorafenib monotherapy, second-line axitinib provides modest efficacy with tolerable toxicity. The discrepant tumor responses and survival outcomes in trials using axitinib as salvage therapy highlight the importance of optimal patient selection with the aid of clinical biomarkers.
BACKGROUND:

Multikinase inhibitors have been effective treatment for hepatocellular carcinoma (HCC). This multicenter phase II study explored the efficacy and safety of second-line axitinib for advanced HCC.
METHODS:

Patients with advanced HCC and Child-Pugh A liver function, experiencing progression on first-line sorafenib monotherapy, were eligible. Axitinib 5 mg twice daily was given continuously with allowed dose escalation. Tumor assessment was performed according to RECIST version 1.1. The primary endpoint was rate of disease control.
RESULTS:

From April 2011 to March 2016, 45 patients were enrolled. Thirty-seven patients (82%) tested positive for hepatitis B surface antigen. The disease control rate was 62.2%, and the response rate was 6.7%, according to RECIST criteria. Median progression-free survival (PFS) and overall survival (OS) were 2.2 months and 10.1 months, respectively. Treatment-related adverse events were compatible with previous reports of axitinib.
CONCLUSION:

Second-line axitinib has moderate activity and acceptable toxicity for patients with advanced HCC after failing the first-line sorafenib monotherapy.

© AlphaMed Press 2020.

PMID:
    32271494
DOI:
    10.1634/theoncologist.2020-0143

StephenW

肿瘤科医生。 2020 Apr 9. doi：10.1634 / theoncologist.2020-0143。 [Epub提前发行]
一线索拉非尼单药治疗失败的晚期肝细胞癌二线阿昔替尼的多中心II期研究。
林ZZ1,2,3，陈BB4，洪YP5，黄PH2，沉YC1,2,6，邵YY2,6，许CH1,2,6，程AL1,2,3,6，李RC7，朝Y5， 8，徐C1,2,6。
作者信息

1个
国立台湾大学癌症中心，肿瘤内科，台湾台北。
2
国立台湾大学附属医院肿瘤科，台湾台北。
3
国立台湾大学医学院内科，台湾台北。
4
国立台湾大学医院放射科，台湾台北。
5
台湾台北市台北荣民总医院肿瘤科。
6
国立台湾大学医学院肿瘤研究所，台湾台北。
7
台湾台北市台北荣民总医院放射科。
8
国立阳明大学医学院，台湾台北。

抽象
得到教训：

对于一线索拉非尼单药治疗失败后的晚期肝细胞癌患者，二线阿西替尼可提供中等疗效并具有可耐受的毒性。在使用阿昔替尼作为挽救疗法的试验中，不同的肿瘤反应和生存结果突出了借助临床生物标记物进行最佳患者选择的重要性。
背景：

多激酶抑制剂已有效治疗肝细胞癌（HCC）。这项多中心II期研究探索了二线阿昔替尼治疗晚期HCC的疗效和安全性。
方法：

患有晚期HCC和Child-Pugh A肝功能且在一线索拉非尼单药治疗中进展的患者符合条件。每天两次给予Axitinib 5 mg，并逐步增加剂量。根据RECIST 1.1版进行肿瘤评估。主要终点是疾病控制率。
结果：

从2011年4月到2016年3月，招募了45位患者。三十七名患者（82％）的乙肝表面抗原检测阳性。根据RECIST标准，疾病控制率为62.2％，缓解率为6.7％。中位无进展生存期（PFS）和总体生存期（OS）分别为2.2个月和10.1个月。与治疗相关的不良事件与阿西替尼的先前报道相符。
结论：

一线索拉非尼单药治疗失败后，二线阿昔替尼对中度肝癌患者具有中等活性和可接受的毒性。

©AlphaMed Press 2020。

PMID：
32271494
DOI：
10.1634 /肿瘤科医生.2020-0143