TY - JOUR
T1 - Transarterial chemoembolization plus sorafenib
T2 - A sequential therapeutic scheme for HCV-related intermediate-stage hepatocellular carcinoma: A randomized clinical trial
AU - Sansonno, Domenico
AU - Lauletta, Gianfranco
AU - Russi, Sabino
AU - Conteduca, Vincenza
AU - Sansonno, Loredana
AU - Dammacco, Franco
PY - 2012
Y1 - 2012
N2 - Background. Recurrence of hepatocellular carcinoma (HCC) is a major problem after surgical or ablative treatments. The aim of this prospective, single-center, placebocontrolled, randomized, double-blind clinical study was to evaluate the effectiveness of transarterial chemoembolization (TACE) combined with sorafenib as a sequential treatment regimen in delaying time to progression (TTP) of intermediate-stage HCC in patients with chronic hepatitis C virus (HCV) infection. Material and Methods. Between October, 2007 and January, 2011, 80 HCV-infected patients with Barcelona Clinic Liver Cancer stage B HCC underwent the TACE procedure. All had Child-Pugh class A disease. They were randomized 1:1 to receive sorafenib at a dose of 400 mg twice daily or placebo. Endpoints were the TTP and the rates of adverse events and toxicity. Results. Sixty-two of 80 patients (77%), 31 in the sorafenib group and 31 in the control group, completed the study. The median TTP was 9.2 months in the sorafenib group and 4.9 months in the placebo group (hazard ratio, 2.5; 95% confidence interval, 1.66-7.56; p
AB - Background. Recurrence of hepatocellular carcinoma (HCC) is a major problem after surgical or ablative treatments. The aim of this prospective, single-center, placebocontrolled, randomized, double-blind clinical study was to evaluate the effectiveness of transarterial chemoembolization (TACE) combined with sorafenib as a sequential treatment regimen in delaying time to progression (TTP) of intermediate-stage HCC in patients with chronic hepatitis C virus (HCV) infection. Material and Methods. Between October, 2007 and January, 2011, 80 HCV-infected patients with Barcelona Clinic Liver Cancer stage B HCC underwent the TACE procedure. All had Child-Pugh class A disease. They were randomized 1:1 to receive sorafenib at a dose of 400 mg twice daily or placebo. Endpoints were the TTP and the rates of adverse events and toxicity. Results. Sixty-two of 80 patients (77%), 31 in the sorafenib group and 31 in the control group, completed the study. The median TTP was 9.2 months in the sorafenib group and 4.9 months in the placebo group (hazard ratio, 2.5; 95% confidence interval, 1.66-7.56; p
KW - Hepatitis C virus
KW - Hepatocellular carcinoma
KW - Liver cirrhosis
KW - Sorafenib
KW - Time to progression
UR - http://www.scopus.com/inward/record.url?scp=84859381338&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84859381338&partnerID=8YFLogxK
U2 - 10.1634/theoncologist.2011-0313
DO - 10.1634/theoncologist.2011-0313
M3 - Article
C2 - 22334456
AN - SCOPUS:84859381338
VL - 17
SP - 359
EP - 366
JO - Oncologist
JF - Oncologist
SN - 1083-7159
IS - 3
ER -