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.
PMID : 27856136
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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 -
ABSTRACT
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.
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