Chinese Medical Sciences Journal ›› 2014, Vol. 29 ›› Issue (1): 7-14.doi: 10.1016/S1001-9294(14)60017-1

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Sorafenib in Liver Function Impaired Advanced Hepatocellular Carcinoma

You-xin Ji1, *, Zhong-fa Zhang2, Ke-tao Lan1, Ke-ke Nie2, Chuan-xin Geng1, Shi-chao Liu2, Ling Zhang2, Xing-jun Zhuang3, Xiao Zou1, Lei Sun2, Zong-chun Zhang2   

  1. 1Department of Oncology, Qingdao Central Hospital, The Second Affiliated Hospital of Qingdao University, Qingdao 266042, China; 2Department of Radiotherapy, Qingdao Cancer Hospital, Qingdao 266042, China; 3Department of Oncology, PLA 401 Hospital, Qingdao 266001, China
  • Received:2013-12-25 Published:2014-03-31 Online:2014-03-31
  • Contact: Tel:86-532-68665078,

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.

Key words: sorafenib, hepatocullelar carcinoma, best supportive care, survival

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