索拉非尼治疗中晚期肝癌预后因素分析

Prognostic factor analysis of moderate-advanced hepatocellular carcinoma treated with sorafenib

目的探索索拉非尼治疗中晚期肝癌患者的预后影响因素。方法回顾性分析2010年2月至2015年6月经病理证实或临床影像诊断,并符合巴塞罗那肝癌分期(BCLC)标准的中晚期肝细胞癌患者38例,口服索拉非尼,400 mg/次,2次/d,每4~6周根据mRECIST标准进行肿瘤应答的评价,并记录不良反应的发生情况,按美国国立癌症研究所常见不良反应分级标准3.0版评估药物毒性。结果 38例患者中1例服药2周后发生肝性脑病停药,37例患者中14例患者出现不同程度胰腺萎缩(阳性组),中位无疾病进展时间(mPFS)9.0个月,中位总生存时间(mOS)25.8个月;23例患者未出现胰腺萎缩(阴性组),中位无疾病进展时间(mPFS)3.3个月,中位总生存时间(mOS)8.4个月,两组mOS比较P<0.001,两组mPFS比较P=0.025,均有统计学意义。主要不良反应为手足皮肤反应、腹泻、乏力、体重下降,均经对症处理后缓解,无严重不良反应发生。结论索拉非尼的疗效与胰腺萎缩呈一定相关性,出现严重腹泻并发胰腺萎缩的患者可获得较长的生存时间和疾病稳定状态。

Objective To investigate the factors that may affect the prognosis of patients with moderate-advanced hepatocellular carcinoma （HCC） who are receiving sorafonib therapy. Methods The clinical data of 38 HCC patients, whose diagnoses were confirmed by pathology or clinical imaging and were in accord with the Barcelona Clinic Liver Cancer （BCLC） staging criteria, were retrospectively analyzed. Sorafenib 400 mg was orally given twice everyday, and according to modified RECIST criteria the tumor response was evaluated once every 4-6 weeks, the adverse events were recorded, and the drug toxicity was evaluated by grading standard 3.0 edition for common adverse reactions formulated by American National Cancer Institute. Results Among the 38 patients, one patient developed hepatic encephalopathy after took sorafenib for two weeks, and medication had to be stopped. Of other 37 patients, 14 patients developed pancreatic atrophy in different degrees （positive group）, the median progression free survival （mPFS） was 9.0 months, and the median overall survival （mOS） was 25.8 months; pancreatic atrophy didn＇t occurred in the remaining 23 patients （negative group）, the mPFS was 3.3 months, and the mOS was 8.4 months. The differences in mPFS and in mOS between the two groups were statistically significant （P〈0.01 and P=0.025 respectively）. The main adverse events included hand-foot skin reaction, diarrhea, fatigue and weight loss, which were relieved after symptomatic treatment, and no severe untoward effect occurred. Conclusion Certain correlation exists between pancreatic atrophy and the curative effect of sorafenib. For patients who develop severe diarrhea associated with pancreatic atrophy, a longer survival time as well as a longer stable state of disease can be expected.