索拉非尼治疗进展期肝细胞癌的疗效及预后因素分析

Efficacy of Sorafenib for Advanced Hepatocellular Carcinoma and Prognostic Factors

目的:评价索拉非尼治疗进展期肝细胞癌(HCC)的疗效及分析其预后影响因素方法:前瞻性分析2007年8月至2009年7月间110例接受索拉非治疗的进展期HCC患者,评价其疗效、不良反应,以总生存期和无肿瘤进展生存期为预后指标进行单因素和Cox比例风险模型多因素分析。结果:110例患者随访中位时间9(2～18)个月,服用索拉非尼中位时间6.5(2～18)个月14例(12.7%)获得完全缓解(CR),16例(14.5%)部分缓解(PR),40例(36.4%)病情稳定(SD),总有效率为70例(63.6%)。中位生存期和无肿瘤进展生存期分别为10.5个月(95%CI:8.7～12-3)和5.0个月(95%CI:3.7～63)。多因素分析显示:联合局部治疗(肝动脉化疗栓塞或氩氦刀)、美国东部肿瘤协作组活动状态评分(Eastern Cooperative OncologyGroup performanee slatus score,ECOG PS)和Child-Pugh分级是影响无肿瘤进展生存时间的独立预后因素,而联合局部治疗、ECOG PS评分和AFP(alfa-fetopro-lein)水平是影响总生存期的独立预后因素。亚组分析显示:在肝癌进展组患者中继续服用索拉非尼其总生存期明显长于终止索拉非尼治疗者(11个月vs.7.5个月,P<0.001)。结论:索拉非尼治疗进展期HCC,ECOG PS评分是影响生存期的一个重要因素。

Objective： To evaluate the efficacy and analyze the prognostic factors of sorafenib treatment in patients with advanced hepatocellular carcinoma （ HCC ）. Methods： Baseline characteristics and outcomes of 110 patients with advanced HCC treated with sorafenib with/without local therapy from a single liver cancer center were collected. Predictors of progress-free survival （ PFS ） and overall survival （ OS ） were determined by multivariable analysis. Results： Complete response was observed in 14 patients （ 12.7% ）, partial response （ PR ） in 16 patients （ 14.5% ）, and stable disease （ SD ） in 40 patients （ 36.4% ）. The therapeutic effective rate was 63.6%. The median OS and PFS for the entire cohort were 10.5 months （ 95% CI, 8.7-12.3 months ） and 5.0 months （ 95% CI, 3.7-6.3 months ）, respectively. Sorafenib combined with local treatment （ transarterial chemoembolization with/without cryoablation ） was an independent predictor of good PFS. Two negative factors, namely, the Eastern Cooperative Oncology Group （ ECOG ） perfor- mance status （ PS ） and Child-Pugh class, predicted poor PFS independently. The ECOG PS and alfa-fetoprotein were found to be inde- pendent adverse predictors of the OS, whereas the combination of local treatment was an independent predictor of good OS. In a subset of patients with progressive disease, a significant difference was found between the OS rates of patients with continuous sorafenib treat-ment and those who discontinued the therapy （ 11 months vs. 7.5 months, P 〈 0.001 ）. Conclusion： The ECOG PS is an important pre-dictor for survival rate of patients with advanced HCC. Sorafenib combined with local therapy may achieve better outcomes for these patients. The survival benefit of the combined treatment of sorafenib with local therapy warrants further studies.