Sorafenib in liver function impaired advanced hepatocellular carcinoma.
- Author:
You-xin JI
1
;
Zhong-fa ZHANG
2
;
Ke-tao LAN
1
;
Ke-ke NIE
2
;
Chuan-xin GENG
1
;
Shi-chao LIU
2
;
Ling ZHANG
2
;
Xing-jun ZHUANG
3
;
Xiao ZOU
1
;
Lei SUN
2
;
Zong-chun ZHANG
2
Author Information
- Publication Type:Journal Article
- MeSH: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; administration & dosage; adverse effects; therapeutic use; Carcinoma, Hepatocellular; drug therapy; mortality; pathology; Cross-Over Studies; Disease-Free Survival; Female; Humans; Kaplan-Meier Estimate; Liver Function Tests; Liver Neoplasms; drug therapy; mortality; pathology; Male; Middle Aged; Neoplasm Invasiveness; Neoplasm Staging; Niacinamide; administration & dosage; adverse effects; analogs & derivatives; therapeutic use; Phenylurea Compounds; administration & dosage; adverse effects; therapeutic use; Treatment Outcome; Young Adult
- From: Chinese Medical Sciences Journal 2014;29(1):7-14
- CountryChina
- Language:English
-
Abstract:
OBJECTIVETo explore the efficacy and safty of sorafenib in Child-Pugh class B to class C hepatocellular carcinoma (HCC).
METHODSIn 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.
RESULTSThe 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.
CONCLUSIONSSorafenib 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.
