Sorafenib in liver function impaired advanced hepatocellular carcinoma.
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.
Department of Oncology, Qingdao Central Hospital, The Second Affiliated Hospital of Qingdao University, Qingdao 266042, China.
You-xin
YX
Ji
Department of Radiotherapy, Qingdao Cancer Hospital, Qingdao 266042, China.
Zhong-fa
ZF
Zhang
Department of Oncology, Qingdao Central Hospital, The Second Affiliated Hospital of Qingdao University, Qingdao 266042, China.
Ke-tao
KT
Lan
Department of Radiotherapy, Qingdao Cancer Hospital, Qingdao 266042, China.
Ke-ke
KK
Nie
Department of Oncology, Qingdao Central Hospital, The Second Affiliated Hospital of Qingdao University, Qingdao 266042, China.
Chuan-xin
CX
Geng
Department of Radiotherapy, Qingdao Cancer Hospital, Qingdao 266042, China.
Shi-chao
SC
Liu
Department of Radiotherapy, Qingdao Cancer Hospital, Qingdao 266042, China.
Ling
L
Zhang
Department of Oncology, PLA 401 Hospital, Qingdao 266001, China.
Xing-jun
XJ
Zhuang
Department of Oncology, Qingdao Central Hospital, The Second Affiliated Hospital of Qingdao University, Qingdao 266042, China.
Xiao
X
Zou
Department of Radiotherapy, Qingdao Cancer Hospital, Qingdao 266042, China.
Lei
L
Sun
Department of Radiotherapy, Qingdao Cancer Hospital, Qingdao 266042, China.
Zong-chun
ZC
Zhang
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018592:Cross-Over Studies; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008111:Liver Function Tests; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077157:Sorafenib; D016896:Treatment Outcome; D055815:Young Adult
D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib