[Clinical observation of sorafenib monotherapy in Chinese patients with advanced hepatocellular carcinoma].
OBJECTIVE
To observe the efficacy and safety of sorafenib monotherapy in Chinese patients with advanced hepatocellular carcinoma (HCC).


METHODS
Thirty-eight patients with advanced HCC of Child-Pugh status A or B were included in this study. Patients received orally administered sorafenib at a dose of 400 mg twice a day on a continuous schedule. Adverse events were documented. The efficacy and safety were evaluated every four to six weeks.


RESULTS
During the treatment, partial response (PR) was observed in 1 patient (2.6%), minor response (MR) in 5 (13.2%), stable disease (SD) in 16 (42.1%), and progressive disease (PD) in 16 (42.1%), respectively. The median oral administration time of sorafenib was 180 days (range, 15-550 d), and the mean overall survival was 370 days (range, 42-562 days). The median response duration was 169 days (range, 42-426 days). The mean overall survival of 22 patients with controlled disease (PR + MR + SD) was 428 days (95% CI 330-526 days). The most frequent adverse events were dermal reaction (27 cases, 71.1%), gastrointestinal reaction (25 cases, 65.8%), and constitutional symptoms (14 cases, 36.8%). Most of the drug related adverse events were mild and easily to manage and reversible.


CONCLUSIONS
Sorafenib monotherapy is effective and tolerable in a part of Chinese patients with advanced hepatocellular carcinoma and liver function of Child-Pugh A or B, and may prolong their survival.
Xu
Li
L
State Key Laboratory of Oncology in Southern China, Department of Hepatobiliary Surgery, Cancer Center, Sun Yat-sen University, Guangzhou 510060, China.
Li
Peng
P
Lin
Xiao-jun
XJ
Yuan
Yun-fei
YF
Zhang
Ya-qi
YQ
Chen
Min-shan
MS
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D005260:Female; D005533:Foot Dermatoses / Q000139:chemically induced; D006229:Hand Dermatoses / Q000139:chemically induced; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D012074:Remission Induction; D000077157:Sorafenib; D015996:Survival Rate; D013577:Syndrome; D055815:Young Adult
D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib