Objective To explore the efficacy and safty of sorafenib in Child-Pugh class B to class C hepatocellular carcinoma(HCC).Methods In this three-center open-label study from November 2011 to May 2013,we randomly assigned...Objective To explore the efficacy and safty of sorafenib in Child-Pugh class B to class C hepatocellular carcinoma(HCC).Methods In this three-center open-label study from November 2011 to May 2013,we randomly assigned 189 patients with advanced Child-Pugh class B or C HCC patients into two groups,one group with 95 patient to receive sorafenib(400 mg a time,twice a day) and the other group with 94 patients to receive best supportive care.The primary end points were progression-free survival and overall survival.Results The median progression-free survival was 2.2 months and 1.9 months in the sorafenib group and best supportive care group respectively(Hazard ratio in the sorafenib group,0.55;95% confidence interval,0.40-0.75;P=0.002).The median overall survival was 4.0 months and 3.5 months in the sorafenib group and best supportive care group respectively(Hazard ratio in the sorafenib group,0.48;95% confidence interval,0.35-0.68;P<0.001).The main adverse effect of sorafenib was rash and acne of the skin(in 51.7% patients).The incidences of severe rash,diarrhea,and dry skin were 5.6%,5.6%,and 2.2% in the sorafenib group.One patient reached partial response in the sorafenib group.Conclusions Sorafenib is safe in patients with liver function impaired advanced HCC.It is effective in terms of progression-free survival and overall survival compared with best supportive care.Liver functions are the important predictive factors.展开更多
文摘Objective To explore the efficacy and safty of sorafenib in Child-Pugh class B to class C hepatocellular carcinoma(HCC).Methods In this three-center open-label study from November 2011 to May 2013,we randomly assigned 189 patients with advanced Child-Pugh class B or C HCC patients into two groups,one group with 95 patient to receive sorafenib(400 mg a time,twice a day) and the other group with 94 patients to receive best supportive care.The primary end points were progression-free survival and overall survival.Results The median progression-free survival was 2.2 months and 1.9 months in the sorafenib group and best supportive care group respectively(Hazard ratio in the sorafenib group,0.55;95% confidence interval,0.40-0.75;P=0.002).The median overall survival was 4.0 months and 3.5 months in the sorafenib group and best supportive care group respectively(Hazard ratio in the sorafenib group,0.48;95% confidence interval,0.35-0.68;P<0.001).The main adverse effect of sorafenib was rash and acne of the skin(in 51.7% patients).The incidences of severe rash,diarrhea,and dry skin were 5.6%,5.6%,and 2.2% in the sorafenib group.One patient reached partial response in the sorafenib group.Conclusions Sorafenib is safe in patients with liver function impaired advanced HCC.It is effective in terms of progression-free survival and overall survival compared with best supportive care.Liver functions are the important predictive factors.
