索拉非尼治疗不能手术的原发性肝细胞癌的疗效及预后因素  

Therapeutic efficacy and prognostic factors of sorafenib treatment in patients with unresectable primary hepatocellular carcinoma

作　　者：张岚[1] 任正刚[1] 干育红[1] 王艳红[1] 张博恒[1] 陈漪[1] 谢晓莺[1] 葛宁灵[1] 叶胜龙[1] 

机构地区：[1]复旦大学附属中山医院肝肿瘤内科,上海200032

出　　处：《中华肿瘤杂志》2010年第8期630-633,共4页Chinese Journal of Oncology

摘　　要：目的 研究索拉非尼治疗不能手术的原发性肝细胞癌（HCC）的疗效以及预后影响因素.方法 2005年12月至2009年3月间,50例肝功能分级为Child-Pugh A级的不能手术的原发性HCC患者连续口服索拉非尼治疗,索拉非尼用法为400 mg/次,每日2次.每6～8周复查CT或MRI,根据实体瘤疗效评价标准（RECIST）进行疗效评价,根据美国国立癌症研究所常见毒性分级标准评价不良反应,观察患者的总生存时间（OS）和疾病进展时间（TTP）.结果 50例患者均可评价疗效,其中疾病稳定（SD）28例,疾病稳定率为56.0%;疾病进展（PD）22例,占44.0%;无完全缓解（CR）和部分缓解（PR）患者.中位随访时间为15个月,随访期间共有17例患者死亡,全组患者的中位TTP为4个月,中位OS为14个月.索拉非尼治疗不能手术的原发性HCC患者的不良反应为皮肤损害、腹泻、高血压、脱发、骨髓抑制和肝功能损害等,大多为Ⅰ～Ⅱ级,经对症处理或调整用药剂量后多可恢复.单因素分析结果显示,有无远处转移是影响HCC患者TTP的主要因素.结论 索拉非尼可有效治疗不能手术的原发性HCC,有无远处转移是影响HCC患者TTP的主要因素.Objective To evaluate the efficacy and analyze the prognostic factors of sorafenib treatment in patient with unresectable primary hepatocellular carcinoma （ HCC ）. Methods During the period from December 2005 to March 2009, 50 patients with unresectable primary HCC of Child-Pugh status A were treated with sorafenib （ 400 mg, Bid）. The tumor response was evaluated with CT or MRI imaging every 6-8 weeks according to the RECIST criteria. The overall survival （OS） and time to progression （TTP）were defined as the time from administration of sorafenib to the death or the last follow up and were evaluated by Kaplan-Meier method. Results There was no PR or CR, but 28 patients （56.0%） achieved stable disease. The median follow up time was 15 months with a median OS of 14 months and median TTP of 4 months. The common adverse events were dermal reaction （68.0%, 34/50）, diarrhea （52.0%, 26/50）,hypertension （4.0%, 2/50）, hair loss （ 14.0%, 7/50）, myelosuppression （ 16.0%, 8/50）, and liver dysfunction （20.0%, 10/50）. However, most of the drug-related adverse events were grade Ⅰ-Ⅱ and reversible. The patients with lower tumor burden and without distant metastasis had better prognosis.Conclusion Soafenib is effective for unresectable primary HCC with tolerable toxicity. Tumor stage is a predominant prognostic factor.

关 键 词：癌 肝细胞 索拉非尼 预后 生存 

分 类 号：R686[医药卫生—骨科学]