Chan Kun-Ming, Wu Tsung-Han, Cheng Chih-Hsien, Lee Chen-Fang, Wu Ting-Jung, Chou Hong-Shiue, Lee Wei-Chen
Department of General Surgery and Department of Organs Transplantation Institute, Chang G Memorial Hospital at Linkou, Chang Gung University College of Medicine, Taoyuan, Taiwan,
Cancer Manag Res. 2019 Jan 22;11:1013-1021. doi: 10.2147/CMAR.S186678. eCollection 2019.
Sorafenib is the first regimen listed in the treatment algorithm for hepatocellular carcinoma (HCC) worldwide. This study aimed to assess the efficacy of sorafenib treatment for advanced HCC in a clinical practice using a nationwide population study.
All patients registered with a diagnosis of primary HCC and identified as having been prescribed sorafenib between August 2012 and December 2015 were selected from a national database and retrospectively reviewed. Outcomes related to prescription of sorafenib for these patients were further assessed.
A total of 9,738 patients were enrolled and analyzed. As a result, 32.33% of patients had an initial treatment response and were eligible for the prescribed second term (240 tablets/ term) of sorafenib and 8.91% of patients received more than three terms of sorafenib. Meanwhile, the duration of sorafenib usage beyond 6 months was noted in 15.49% of patients, including 10.59% of patients with a period of usage between 6 and 12 months and 4.9% of patients with more than 12 months usage. Survival analysis showed that patients who received locoregional therapy plus sorafenib had significantly better survival rates than those who underwent only sorafenib treatment. Certain patients who underwent hepatectomy (n=12) or liver transplantation (n=13) were subsequently free of HCC.
The disease control rate of sorafenib in advanced HCC patients in this study seemed similarly poorer as what has been previously reported by clinical trials. The combination of sorafenib and additional treatments could perhaps provide survival benefits and possibly cure disease in combination with surgical management.
索拉非尼是全球肝细胞癌（HCC）治疗方案中首个被列入的药物。本研究旨在通过一项全国性人群研究，评估索拉非尼在临床实践中治疗晚期HCC的疗效。
从国家数据库中选取2012年8月至2015年12月期间登记诊断为原发性HCC并被确定已开具索拉非尼处方的所有患者，并进行回顾性分析。进一步评估这些患者使用索拉非尼处方的相关结果。
共纳入并分析了9738例患者。结果显示，32.33%的患者有初始治疗反应，符合规定的索拉非尼第二疗程（240片/疗程）用药标准，8.91%的患者接受了超过三个疗程的索拉非尼治疗。同时，15.49%的患者索拉非尼使用时间超过6个月，其中10.59%的患者使用时间在6至12个月之间，4.9%的患者使用时间超过12个月。生存分析表明，接受局部区域治疗联合索拉非尼的患者生存率明显高于仅接受索拉非尼治疗的患者。部分接受肝切除术（n = 12）或肝移植（n = 13）的患者随后无HCC复发。
本研究中晚期HCC患者的索拉非尼疾病控制率似乎与先前临床试验报道的情况同样较差。索拉非尼与其他治疗方法联合使用可能会带来生存益处，并可能与手术治疗相结合治愈疾病。
