Korean Multicenter Registry of Transcatheter Arterial Chemoembolization with Drug-Eluting Embolic Agents for Nodular Hepatocellular Carcinomas: Six-Month Outcome Analysis
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…
How strong is the evidence?
Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 152 participants or records.
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