title: Korean Multicenter Registry of Transcatheter Arterial Chemoembolization with Drug-Eluting Embolic Agents for Nodular Hepatocellular Carcinomas: Six-Month Outcome Analysis.
abstract: OBJECTIVE
  To assess the efficacy and safety of transcatheter arterial chemoembolization with drug-eluting embolic (DEE) agents for nodular hepatocellular carcinoma (HCC).
  
  
  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.
authors.affiliation: Department of Radiology, Seoul National University Hospital, Seoul; Seoul; Department of Radiology, Seoul.
authors.forename: Myungsu
authors.initials: M
authors.lastname: Lee
authors.affiliation: Department of Radiology, Seoul National University Hospital, Seoul; Seoul; Department of Radiology, Seoul; Institute of Radiation Medicine, Seoul National University Medical Research Center; Seoul. Electronic address: chungjw@snu.ac.kr.
authors.forename: Jin Wook
authors.initials: JW
authors.lastname: Chung
authors.affiliation: Department of Radiology; Research Institute of Radiological Science, Yonsei University College of Medicine; Seoul.
authors.forename: Kwang-Hun
authors.initials: KH
authors.lastname: Lee
authors.affiliation: Department of Radiology; Research Institute of Radiological Science, Yonsei University College of Medicine; Seoul.
authors.forename: Jong Yun
authors.initials: JY
authors.lastname: Won
authors.affiliation: Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul.
authors.forename: Ho Jong
authors.initials: HJ
authors.lastname: Chun
authors.affiliation: Department of Gastroenterology, Asan Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Ulsan.
authors.forename: Han Chu
authors.initials: HC
authors.lastname: Lee
authors.affiliation: Department of Radiology and Research Institute of Radiology, Asan Liver Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
authors.forename: Jin Hyoung
authors.initials: JH
authors.lastname: Kim
authors.affiliation: Department of Radiology, National Cancer Center, Goyang, Republic of Korea.
authors.forename: In Joon
authors.initials: IJ
authors.lastname: Lee
authors.affiliation: Department of Radiology, Seoul National University Hospital, Seoul; Seoul; Department of Radiology, Seoul.
authors.forename: Saebeom
authors.initials: S
authors.lastname: Hur
authors.affiliation: Department of Radiology, Seoul National University Hospital, Seoul; Seoul; Department of Radiology, Seoul.
authors.forename: Hyo-Cheol
authors.initials: HC
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul; Seoul.
authors.forename: Yoon Jun
authors.initials: YJ
authors.lastname: Kim
authors.affiliation: Department of Radiology; Research Institute of Radiological Science, Yonsei University College of Medicine; Seoul.
authors.forename: Gyoung Min
authors.initials: GM
authors.lastname: Kim
authors.affiliation: Department of Radiology; Research Institute of Radiological Science, Yonsei University College of Medicine; Seoul.
authors.forename: Seung-Moon
authors.initials: SM
authors.lastname: Joo
authors.affiliation: Department of Radiology, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul.
authors.forename: Jung Suk
authors.initials: JS
authors.lastname: Oh
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D001660:Biliary Tract Diseases / Q000209:etiology; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects / Q000401:mortality; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D004337:Drug Carriers; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016016:Proportional Hazards Models; D011446:Prospective Studies; D012042:Registries; D056910:Republic of Korea; D013997:Time Factors; D016896:Treatment Outcome; D047368:Tumor Burden
chemical_list: D000903:Antibiotics, Antineoplastic; D004337:Drug Carriers; D004317:Doxorubicin