[Therapeutic efficacy and prognostic factors of sorafenib treatment in patients with unresectable primary hepatocellular carcinoma].
OBJECTIVE
To evaluate the efficacy and analyze the prognostic factors of sorafenib treatment in patient with unresectable primary hepatocellular carcinoma (HCC).


METHODS
During the period from December 2005 to March 2009, 50 patients with unresectable primary HCC of Child-Pugh status A were treated with sorafenib (400 mg, Bid). The tumor response was evaluated with CT or MRI imaging every 6 - 8 weeks according to the RECIST criteria. The overall survival (OS) and time to progression (TTP) were defined as the time from administration of sorafenib to the death or the last follow up and were evaluated by Kaplan-Meier method.


RESULTS
There was no PR or CR, but 28 patients (56.0%) achieved stable disease. The median follow up time was 15 months with a median OS of 14 months and median TTP of 4 months. The common adverse events were dermal reaction (68.0%, 34/50), diarrhea (52.0%, 26/50), hypertension (4.0%, 2/50), hair loss (14.0%, 7/50), myelosuppression (16.0%, 8/50), and liver dysfunction (20.0%, 10/50). However, most of the drug-related adverse events were grade I-II and reversible. The patients with lower tumor burden and without distant metastasis had better prognosis.


CONCLUSIONS
Soafenib is effective for unresectable primary HCC with tolerable toxicity. Tumor stage is a predominant prognostic factor.
Liver Cancer Institute, Zhongshan Hospital, Fudan University, Shanghai, China.
Lan
L
Zhang
Zheng-gang
ZG
Ren
Yu-hong
YH
Gan
Yan-hong
YH
Wang
Bo-heng
BH
Zhang
Yi
Y
Chen
Xiao-ying
XY
Xie
Nin-ling
NL
Ge
Sheng-long
SL
Ye
D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods; D003967:Diarrhea / Q000139:chemically induced; D018450:Disease Progression; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D012871:Skin Diseases / Q000139:chemically induced; D000077157:Sorafenib; D015996:Survival Rate
D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib