临床肿瘤学杂志

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索拉非尼治疗43例中晚期肝细胞癌的临床观察

王楠娅,赵恒军,何华,苗凤华,崔国振,李薇   

  1. WANG Nanya, ZHAO Hengjun, HE Hua, MIAO Fenghua, CUI Guozhen, LI Wei.
  • 收稿日期:2013-02-08 修回日期:2013-04-26 出版日期:2013-08-31 发布日期:2013-08-31
  • 通讯作者: 赵恒军

Clinical observation of forty-three advanced hepatocellular carcinoma patients treated with sorafenib

WANG Nanya, ZHAO Hengjun, HE Hua, MIAO Fenghua, CUI Guozhen, LI Wei.   

  1. Cancer Center, the First Hospital of Jilin University
  • Received:2013-02-08 Revised:2013-04-26 Online:2013-08-31 Published:2013-08-31
  • Contact: ZHAO Hengjun

摘要: 目的 探讨索拉非尼治疗中晚期肝细胞癌(HCC)的疗效和安全性。方法 回顾性分析吉林大学第一医院肿瘤中心2008年6月至2011年12月持续应用索拉非尼(400mg/次,2次/日)治疗3个月以上的43例中晚期HCC患者,其中22例患者口服索拉非尼单药治疗,另21例患者口服索拉非尼联合局部治疗。评价客观疗效、不良反应及总生存期。结果 全组43例患者获CR 2例,PR 15例,13例持续6个月以上SD,疾病控制率(DCR)为69.8%。其中索拉非尼单药组获PR 2例,SD(持续6个月以上)10例,DCR为54.5%(12/22);索拉非尼联合组获CR 2例,PR 13例,SD(持续6个月以上)3例,DCR为85.7%(18/21)。两组DCR比较,差异有统计学意义(P=0.03)。 43例患者的中位生存期(OS)为22个月(4~39个月)。亚组分析显示,巴塞罗那分期(BCLC)A期患者的中位OS为未达到,B期为12个月,C期为9个月,三者比较差异有统计学意义(P=0.038);肝功能Child-Pugh A级患者的中位OS优于Child-Pugh B级患者(24.0个月vs.4.9个月,P=0.002);索拉非尼联合治疗组的中位OS优于索拉非尼单药组(25.0个月vs.8.7个月,P=0.043)。43例患者的主要不良反应为手足综合征、高血压、腹泻等。除3例出现3级不良反应外,其他均为2级及以下,经对症治疗好转。结论 索拉非尼治疗中晚期HCC安全有效,不良反应多数患者可以耐受。

Abstract: Objective To investigate the efficacy and safety of sorafenib in treatment of advanced hepatocellular carcinoma (HCC). Methods Forty-three mid-advanced patients with HCC who were treated with sorafenib for more than 3 months from June 2008 to December 2011 in Cancer Center of First Hospital of Jilin University were reviewed retrospectively. Twentytwo patients took oral sorafenib alone at a dose of 400mg twice daily. Twentyone patients were treated with sorafenib(400mg po, bid) combined with other regional therapies. The efficacy was evaluated by CT or MRI every 3 months according to the modified response evaluation criteria in solid tumors(mRECIST) and the median overall survival (mOS) time were observed during follow-up. The side effects were evaluated according to NCICTC 3.0 criteria. Results The efficacy of 43 patients could be evaluated. Two patients achieved complete response (CR), 15 patients achieved partial response(PR),13 patients achieved stable disease(SD) lasting for more than 6 months. The disease control rate(DCR) was 69.8%. In sorafenib monotherapy group, none of them achieved CR, 2 patitents attained PR, 10 patients achieved SD lasting for more than 6 months. In combination therapy group, 2 patients achieved CR, 13 patients attained PR, and 3 patients were SD for more than 6 months duration. The disease control rate(DCR) of the combination therapy group was higher than that of sorafenib monotherapy group(85.7% vs.54.5%,P=0.03). The mOS of 43 patients was 22 months (4-39 months). Subgroup analysis according to the BCLC stage suggested patients of stage A had not reached the mOS, while the mOS of patients with stage B was 12 months,and the patients with stage C was 9 months. the mOS of patients with ChildPugh grades A was longer than that of the patients with ChildPugh grades B(24.0 months vs.4.9 months,P=0.002).Furthermore, the patiens treated with sorafenib and other regional treatments had longer mOS than the patients treated with sorafanib monotherapy(25.0 months vs.8.7 months,P=0.043). The most common adverse effects were handfoot skin reaction, hypertension, diarrhea and so on. Only 3 patients got adverse effects in grade 3 and the other 40 patients were less than grade 2. Conclusion Sorafenib is safe and effective for advanced HCC and the side effects were tolerable.

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