Single institution experience of sorafenib for advanced HCC in a US tertiary care hospital.
Single institution experience of sorafenib for advanced HCC in a US tertiary care hospital.
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DOI：
10.21037/jgo.2018.06.09
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发表时间：
2018-10
影响因子：
2.1
通讯作者：
V. Mukthinuthalapati;Yuchen Wang;Yazan Abu Omar;M. Syed;B. Attar
中科院分区：
文献类型：
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作者：
V. Mukthinuthalapati;Yuchen Wang;Yazan Abu Omar;M. Syed;B. Attar
背景 索拉非尼是晚期肝细胞癌 (HCC) 的一线化疗药物。除了 GIDEON 研究的美国部分（一项 IV 期跨国研究）外，在美国人群中使用索拉非尼的实际经验很少。在这种背景下，我们介绍了芝加哥市内三级安全网医院使用索拉非尼治疗 HCC 的单一机构经验。方法 我们回顾性分析了 2009 年至 2016 年接受索拉非尼治疗的 HCC 患者（经放射学标准和/或活检证实）的电子病历。我们收集了有关人口统计学、肿瘤特征、肝硬化、索拉非尼治疗持续时间、报告的索拉非尼不良反应以及索拉非尼开始时进行的实验室检查的数据。总生存期从索拉非尼开始使用时开始计算，如果死亡日期未知，则在最后一次随访日期对病例进行审查。估计 Kaplan-Meier 曲线以评估各种临床变量的预后意义。结果 59 名患者在研究期间接受索拉非尼治疗，中位总生存期为 7 个月（25-75 百分位数=3-15 个月）。酒精是肝硬化的主要原因，其中 64% 的人患有 Child-Turcotte-Pugh (CTP) A 级肝硬化或没有肝硬化，73% 的人在索拉非尼开始治疗时患有巴塞罗那 C 期 HCC。其中近一半的人遭受索拉非尼的不良反应，最常见的是涉及皮肤和肠道的不良反应。 CTP A 级肝硬化或无肝硬化患者（中位 OS 39 与 16 个月，对数秩检验 3.913，P=0.048）、无肝外扩散 (EHS)（中位 OS 39 与 9 个月，对数秩检验 5.632，P=0.018）和丙型肝炎病毒 (HCV) 感染（中位 OS 39 与 9 个月，对数秩检验） 5.015，P=0.025）有更好的生存率。结论 美国接受索拉非尼治疗的 HCC 患者的总生存期低于欧洲或日本队列中观察到的总生存期。 HCV 感染可能是接受索拉非尼治疗 HCC 的患者获益的标志。进一步研究证实这种关联并了解其病理生理学基础可能有助于开发晚期 HCC 的其他治疗方案。
Background Sorafenib is first line chemotherapy for advanced hepatocellular carcinoma (HCC). There are little real-world experiences with sorafenib done on US population except for the US arm of the GIDEON study, a phase IV multi-national study. In this context, we present a single institution experience with sorafenib for HCC in a tertiary inner-city safety-net hospital of Chicago. Methods We retrospectively analyzed electronic medical records of patients with HCC (confirmed with radiographic criteria and/or biopsy) who received sorafenib from 2009 to 2016. We collected data regarding the demographics, characteristics of tumor, liver cirrhosis, duration of treatment with sorafenib, reported adverse effects with sorafenib and laboratory investigations done at the time of sorafenib initiation. Overall survival was calculated from the time of sorafenib initiation and cases were censored at the date of last follow up, if date of death was not known. Kaplan-Meier curves were estimated to evaluate the prognostic significance of various clinical variables. Results Fifty-nine patients received sorafenib in the study period and the median overall survival was 7 months (25-75 percentile =3-15 months). Alcohol was the leading cause of cirrhosis, 64% of them had Child-Turcotte-Pugh (CTP) class A cirrhosis or did not have cirrhosis and 73% had Barcelona stage C HCC at the time of sorafenib initiation. Close to half of them suffered from adverse effects of sorafenib, most common being those involving skin and gut. Patients with CTP class A cirrhosis or no cirrhosis (median OS 39 vs. 16 months, log rank test 3.913, P=0.048), absence of extrahepatic spread (EHS) (median OS 39 vs. 9 months, log rank test 5.632, P=0.018) and hepatitis C virus (HCV) infection (median OS 39 vs. 9 months, log rank test 5.015, P=0.025) had better survival. Conclusions Overall survival of patients with HCC treated with sorafenib in US is lower than those observed in cohorts from Europe or Japan. HCV infection could be a marker of benefit in those treated with sorafenib for HCC. Further studies to confirm this association and understand it's pathophysiologic basis could be useful in development of other therapeutic options for advanced HCC.