Practical efficacy of sorafenib monotherapy for advanced hepatocellular carcinoma patients in a Hepatitis B virus-endemic area.
BACKGROUND
This study was conducted to assess the efficacy and safety of sorafenib monotherapy in clinical practice settings for Korean patients with hepatocellular carcinoma (HCC) related primarily to HBV infection.


METHODS
Medical records of 57 consecutive patients with unresectable or metastatic HCC treated with 400 mg bid sorafenib at the National Cancer Center, Korea between June 2007 and March 2008, were retrospectively reviewed.


RESULTS
The median patient age was 55 years (range, 28-76 years), and all patients had performance status 0-2 and Child-Pugh class A or B disease. HCC was etiologically related to HBV in 79.0% of patients. Eleven patients (19.3%) had modified UICC stage III tumors, 11 (19.3%) had stage IVa, and 35 (61.4%) had stage IVb. Following sorafenib monotherapy, 3 patients (5.3%) achieved a partial response and 18 (35.1%) achieved stable disease, with a disease control rate of 40.4%. The median times to progression (TTP) was 9.1 weeks (95% CI 3.4-14.8 weeks). Multivariate analyses showed that serum alpha-fetoprotein (alpha-FP) > or =400 ng/mL (HR, 2.810; P = 0.023) and the presence of massive intrahepatic tumors (HR, 7.633; P = 0.033) were independent predictors of shorter TTP. The most common grade 3/4 adverse events were hand-foot syndrome (8.8%), diarrhea (7.0%), and skin rash (7.0%). Exacerbation of underlying chronic hepatitis B was not found.


CONCLUSIONS
Sorafenib monotherapy showed better outcomes with tolerable toxicity in Korean advanced HCC patients, who had intrahepatic nodular tumors and/or metastatic tumors, coupled with low levels of serum alpha-FP.
Shim
Ju Hyun
JH
Center for Liver Cancer, National Cancer Center, 809 Madu 1-dong, Ilsan-gu, Goyang, Goyang, Gyeonggi, 411-769, Republic of Korea.
Park
Joong-Won
JW
Choi
Joon-Il
JI
Park
Bum Joon
BJ
Kim
Chang-Min
CM
D000328:Adult; D000368:Aged; D001557:Benzenesulfonates / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D006509:Hepatitis B / Q000453:epidemiology*; D006526:Hepatitis C / Q000453:epidemiology; D006801:Humans; D007723:Korea; 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*; D040262:Receptors, Vascular Endothelial Growth Factor / Q000627:therapeutic use*; D012189:Retrospective Studies; D000077157:Sorafenib; D013997:Time Factors; D016896:Treatment Outcome
D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib; D040262:Receptors, Vascular Endothelial Growth Factor