Korean Multicenter Registry of Transcatheter Arterial Chemoembolization with Drug-Eluting Embolic Agents for Nodular Hepatocellular Carcinomas: Six-Month Outcome Analysis.

Lee, Myungsu; Chung, Jin Wook; Lee, Kwang-Hun; Won, Jong Yun; Chun, Ho Jong; Lee, Han Chu; Kim, Jin Hyoung; Lee, In Joon; Hur, Saebeom; Kim, Hyo-Cheol; Kim, Yoon Jun; Kim, Gyoung Min; Joo, Seung-Moon; Oh, Jung Suk
Journal of vascular and interventional radiology : JVIR
2017Apr ; 28 ( 4 ) :502-512.
저자 상세정보
Lee, Myungsu -
Chung, Jin Wook -
Lee, Kwang-Hun -
Won, Jong Yun -
Chun, Ho Jong -
Lee, Han Chu -
Kim, Jin Hyoung -
Lee, In Joon -
Hur, Saebeom -
Kim, Hyo-Cheol -
Kim, Yoon Jun -
Kim, Gyoung Min -
Joo, Seung-Moon -
Oh, Jung Suk -
PURPOSE: To assess the efficacy and safety of transcatheter arterial chemoembolization with drug-eluting embolic (DEE) agents for nodular hepatocellular carcinoma (HCC). MATERIALS AND

METHODS: The study design was a prospective multicenter registry-based, single-arm clinical trial that included 152 patients. One hundred three (67.8%) had a Child-Pugh class/score of A5, 114 (75.0%) had a performance status of 0, and 77 (50.7%) had Barcelona Clinic Liver Cancer (BCLC) stage A disease. The DEE chemoembolization procedures were performed with DC Bead particles loaded with doxorubicin solution. The primary endpoint of the study was 6-month tumor response assessed per modified Response Evaluation Criteria In Solid Tumors. Secondary endpoints were treatment safety and overall survival.

RESULTS: At 1-month posttreatment assessment, complete response (CR) and objective response (OR; ie, CR or partial response) rates were 40.1% and 91.4%, respectively. At 6-month assessment, 121 patients remained for analysis, and CR and OR rates were 43.0% and 55.4%, respectively. The cumulative progression-free survival (PFS) rate at 6 months was 65.0%. Child-Pugh score, tumor multiplicity, and tumor size were independent predictors of PFS (P = .020, P = .029, and P = .001, respectively). There was no 30-day mortality. The overall 6-month survival rate was 97.4%. There were no grade 4 adverse events or laboratory changes. Serious adverse events were reported in 7.2% of patients, and persistent deterioration of liver function was observed in 3.9%. Prominent biliary injury was demonstrated in 19.7% of patients. No liver abscess was observed.

CONCLUSIONS: DEE chemoembolization for nodular HCC had an acceptable safety profile and acceptable 6-month tumor response and survival rates. CI - Copyright ??2016 SIR. Published by Elsevier Inc. All rights reserved.

주제명(Target field)
연구참여(Sample size)
질병특성(Condition Category)
연구설계(Study Design)
중재방법(Intervention Type)
중재명칭(Intervention Name)
DEE chemoembolization for nodular HCC had an acceptable safety profile and acceptable 6-month tumor response and survival rates.
연구비지원(Fund Source)
근거수준평가(Evidence Hierarchy)
ICD 03