| Objective:Sorafenib is a molecular targeted drugs, through direct inhibition of tumor cell proliferation and angiogenesis blockers, play a dual anti-tumor effect. In recent years, is widely used in the treatment of advanced unresectable hepatocellular carcinoma. It is bcoming the standard of advanced hepatocellular carcinoma medication. This study aimed to investigate the clinic predictor of efficacy and adverse events of sorafenib in treating with advanced hepatocellular carcinoma patients.Methods:From February 2011 to November 2011.57 patients received sorafenib for unresectable or metastatic HCC. There were 51 male and 6 female patients. The mean age was 55.7 years(ranging from 30 to 77 years). Patients received sorafenib orally 400 mg twice daily on a continuous dosing schedule. Every four weeks were followed, including:liver biochemical indices, blood, Eastern Cooperative Oncology Group (ECOG)score, adverse events. Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors(RECIST) every 8 weeks. Toxicity grading was performed using the Common Terminology Criteria for Adverse Events 3.0(CTCAE 3.0). The relationship between different clinic variable factors and curative effects of sorafenib was analyzed by using Cox proportion hazard regression analysis.Comparison incidence of adverse events in patients with different clinical variables, P<0.05 for the difference was statistically significant.Comparison before and after treatment in patients with the change of total bilirubin, albumin and International Normalized Ratio(INR) to be t test, P< 0.05 for the difference was statistically significant.Results:The mean duration of follow-up was 12.8 moths(ranging from 2.5 to 35.5 motns). None of patients achieved complete remission,1 patient achieved partial response.24 patients survived a year or more and 10 patients survived two years or more. The median time to overall survival (OS) was 11.8 months. Multivariate analysis showed that Alpha fetoprotein(AFP)<200ng/ml (HR=1.429, P=0.024), Child-Pugh class A (HR=1.687, P=0.018) and none of venous invasion(HR=2.213,P=0.021) were independent predictors of more extended OS. The common adverse events were hand-foot syndrome 37(82.2%), diarrhea 34(75.6%), hypertension 26(57.8%), grade 2 alopecia 1, grade 1 alopecia 1, low platelet count 1.The incidence of adverse events between Child-Pugh class A and B, different ages(<60,(?)60 years old) and ECOG score 0 and 1 had no statistically significant.Multivariate analysis showed that grade 1-2 hand-foot syndrome (HR=0.277, P=0.006) and gradel-2 diarrhea(HR=0.434, P=0.035)were independent predictors of more extend OS. INR value after sorafebib treatment was elevated than before treatment(1.11 vs 1.04,.P=0.029). Comparison before and after treatment in patients, total bilirubin were 21.73±10.48μmol/L and 25.19±13.04 μmol/L(P=0.283), albumin were 39.15±4.96g/L and 41.27±4.21g/L(P＝0.070), INR werel.04±0.08 and 1.11±0.11 (P=0.029).Conclusion:Sorafenib prolonged overall survival in patients with advanced hepatocellular carcinoma significantly. Patients taked sorafenib continuously, a higher incidence of adverse events, but were usually mild adverse reactions which can be tolerated, and no fatal reaction.After taking sorafenib resulted in elevated INR values, suggesting that there may be some impact on liver function. AFP, Child-Pugh classification, violations of the portal vein, early hand-foot skin reaction and diarrhea were helpful to predict the efficacy of sorafenib. |
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