索拉非尼单药治疗晚期肝细胞癌的临床观察

目的 观察索拉非尼单药治疗晚期肝细胞癌患者的有效性与安全性.方法 38例Child-Pugh A或B级的晚期肝细胞癌患者连续口服索拉非尼,剂量为400 mg/次,2次/d.记录不良反应,每4～6周进行疗效及安全性评价.结果 38例患者中,部分缓解1例(2.6%),轻微缓解5例(13.2%),稳定16例(42.1%),进展16例(42.1%).患者服用索拉非尼的中位时间为180 d(15～550 d),平均总生存时间为370 d(42～562 d).22例肿瘤受控患者(有效和稳定患者)的中位反应持续时间为169 d(42～426 d),平均总生存时间为428 d(95%CI为330～526 d).治疗期间最常见的不良反应为皮肤反应(27例,71.1%)、胃肠反应(25例,65.8%)和全身症状(14例,36.8%).药物相关不良反应大多为轻度,易于处理并可逆.结论 索拉非尼单药治疗对部分晚期肝癌患者有效,并可延长患者的生存时间.肝功能Child-Pugh A级或B级的肝癌患者对索拉非尼耐受性良好.

Clinical observation of sorafenib monotherapy in Chinese patients with advanced hepatocellular carcinoma

Objective To observe the efficacy and safety of sorafenih monotherapy in Chinese patients with advanced hepatocellular carcinoma (HCC). Methods Thirty-eight patients with advanced HCC of Child-Pugh status A or B were included in this study. Patients received orally administered sorafenih at a dose of 400 mg twice a day on a continuous schedule. Adverse events were documented. The efficacy and safety were evaluated every four to six weeks. Results During the treatment, partial response (PR) was observed in 1 patient (2.6%), minor response (MR) in 5 (13.2%), stable disease (SD) in 16 (42.1%), and progressive disease (PD) in 16 (42.1%), respectively. The median oral administration time of sorafenib was 180 days (range, 15～550 d) , and the mean overall survival was 370 days (range, 42～562 days). The median response duration was 169 days (range, 42～426 days). The mean overall survival of 22 patients with controlled disease (PR+MR+SD) was 428 days (95% CI 330～526 days). The most frequent adverse events were dermal reaction (27 cases, 71.1%), gastrointestinal reaction (25 cases, 65.8%), and constitutional symptoms (14 cases, 36.8%). Most of the drug related adverse events were mild and easily to manage and reversible. Conclusion Sorafenib monotherapy is effective and tolerable in a part of Chinese patients with advanced hepatocellular carcinoma and liver function of Child-Pugh A or B, and may prolong their survival.