Zhang Kai, Sun Xiangyang, Xie Fubo, Jian Wencheng, Li Caixia
Department of Radiology, Qilu Hospital of Shandong University, Jinan, China.
J Cancer Res Ther. 2018 Jan;14(1):196-200. doi: 10.4103/jcrt.JCRT_1175_16.
The aim is to study the effectiveness and side effects of sorafenib administration after transarterial chemoembolization (TACE) in advanced hepatocellular carcinoma (HCC) patients. To evaluate the safety of the combination of sorafenib and TACE to treat HCC.
A total of 36 unresectable HCC patients were enrolled. After TACE, administration of sorafenib was carried out. Follow-up was taken for every 4 weeks. Liver and renal function and alpha-fetoprotein were tested. Modified response evaluation criteria in solid tumors (mRECIST) was used to evaluate the clinical effect. The side effects were recorded.
The median overall survival (mOS) and the median time to progress were 12.5 and 8 months with the range from 6 to 32 and 4-30 months, respectively. The mOS of patients with single tumor was 18 months while that of multiple tumors in liver was 10 months (χ = 4.1639, P = 0.0413). According to mRECIST, there were no complete response patients, 2 partial response patients, 10 stable disease patients, and 24 progressive disease patients. Response rate was 5.5% (2/36). Disease control rate (DCR) was 33% (12/36). The main adverse events were hand-foot skin reaction and diarrhea. The frequency of Grade II, III hand-foot-skin reaction was 39%. After treatment, it decreased to 5.6%. Forty-four percentage patients suffered from diarrhea of Grades I and II. After treatment, it decreased to 28%. The mean interval of TACE was 45 days before combination therapy and 120 days after combination therapy.
Administration of sorafenib after TACE could prolong overall survival of advanced HCC patients, keep the stable status longer and extend the interval between TACEs. The side effects are usually treatable, which proves the safety of this combination.
研究索拉非尼在经动脉化疗栓塞术（TACE）后应用于晚期肝细胞癌（HCC）患者的有效性及副作用。评估索拉非尼与TACE联合治疗HCC的安全性。
共纳入36例不可切除的HCC患者。TACE术后给予索拉非尼治疗。每4周进行一次随访。检测肝肾功能及甲胎蛋白。采用实体瘤改良疗效评价标准（mRECIST）评估临床疗效。记录副作用。
中位总生存期（mOS）和中位疾病进展时间分别为12.5个月和8个月，范围分别为6至32个月和4至30个月。单发病灶患者的mOS为18个月，而肝脏多发肿瘤患者的mOS为10个月（χ=4.1639，P=0.0413）。根据mRECIST标准，无完全缓解患者，2例部分缓解患者，10例病情稳定患者，24例疾病进展患者。缓解率为5.5%（2/36）。疾病控制率（DCR）为33%（12/36）。主要不良事件为手足皮肤反应和腹泻。II级、III级手足皮肤反应的发生率为39%。治疗后降至5.6%。44%的患者发生I级和II级腹泻。治疗后降至28%。联合治疗前TACE的平均间隔时间为45天，联合治疗后为120天。
TACE术后应用索拉非尼可延长晚期HCC患者的总生存期，更长时间地维持病情稳定，并延长TACE之间的间隔时间。副作用通常可治疗，这证明了这种联合治疗方法的安全性。
