索拉非尼治疗晚期肝细胞癌的临床观察

Clinical observation on therapeutic effects of sorafenib in advanced hepatocellular cancer

目的：评价索拉非尼治疗晚期肝细胞癌的疗效和不良反应,分析影响疗效的因素。方法：收集2012年1月~2015年7月应用索拉非尼治疗晚期肝细胞癌（hepatocellular carcinoma,HCC）患者完整的临床资料。计算疾病控制率（disease control rate,DCR）并分析影响因素。结果：共收集28例患者资料,患者均未获得完全缓解（CR）或部分缓解（PR）,稳定（SD）16例（57.1%）,进展（PD）12例（42.9%）,疾病控制率57.1%。中位总生存期（overall survival,OS）和中位进展期（time to progress,TTP）分别为8.41个月（3.2~12.7个月）和6.13个月（1~8.6个月）。不良反应大多数为1~2级,最常见的是手足皮肤反应、腹泻、皮疹和高血压,无治疗相关性死亡。Child-Pugh分级和BCLC分期是DCR的影响因素。ECOG评分、Child-Pugh分级和BCLC分期是影响OS及TTP的预后因素。结论：索拉非尼治疗晚期肝细胞癌有较好的疾病控制率,安全性较好。肿瘤的BCLC分期越早,患者的肝功能储备及体力状况越好,接受索拉非尼治疗获益越大。

Objective： To evaluate the clinical efficacy and safety of sorafenib in the treatment of advanced hepatocellular carcinoma,and analyze factors affecting the medication.Methods： Complete medical records were retrospectively examined in 28 patients with advanced hepatocellular carcinoma received sorafenib between January 2012 and July 2015.Fisher＇s exact test was used to identify variables affecting the response rate and disease control rate（ DCR）.Results： No complete remission or partial remission was observed in the 28 patients.Stable disease（ SD） was found in 16 patients（ 57.1%）,progression disease（ PD） in 12（ 42.9%） and DCR in 57.1%.Median overall survival was 8.41 months（ 3.2-12.7 months）,and median time to progression 6.13 months（ 1-8.6 months）.Most adverse events were in grade 1 or 2,primarily including skin reaction at hands and feet,diarrhea,rash and hypertension.No therapy-related death occurred.Risk factors for DCR were associated with grading by Child-Pugh and classification by Barcelona clinic liver cancer（ BCLC）,and prognostic factors,overall survival（ OS） and TTP were involved in the status as eastern cooperative oncology group（ ECOG） as well as grading by ChildPugh and BCLC staging.Conclusion： Sorafenib shows substantial survival benefit and tolerable toxicity in patients with advanced hepatocellular carcinoma,and positive response to the therapy is associated with earlier BCLC stage,better ECOG performance status and Child-Pugh grading.