title: Drug-eluting bead loaded with doxorubicin versus conventional Lipiodol-based transarterial chemoembolization in the treatment of hepatocellular carcinoma: a case-control study of Asian patients.
abstract: OBJECTIVE
  Lipiodol transcatheter arterial chemoembolization (TACE) is widely used to treat hepatocellular carcinoma (HCC). Recently, a drug-eluting bead (DEB) has been developed to enhance drug delivery to the tumor and reduce its systemic availability. The purpose of this study was to compare the efficacy and safety of intra-arterial injection of DEB loaded with doxorubicin versus conventional, Lipiodol-based TACE regimens in Asian patients with HCC.
  
  
  METHODS
  The study was designed as a case-control, single-institution clinical trial. Twenty patients with HCC who received DEB loaded with 50 mg doxorubicin ('cases') were matched with 20 patients who had undergone conventional TACE ('controls'). The primary efficacy endpoint was tumor response at 1 month according to modified Response Evaluation Criteria in Solid Tumors. The primary safety endpoint was liver toxicity.
  
  
  RESULTS
  The rate of objective response by modified Response Evaluation Criteria in Solid Tumors was 85% (17 of 20 patients) in the DEB arm versus 30% (six of 20 patients) in the conventional TACE arm (P=0.001). Subgroup analyses conducted in patients with large (>5 cm) or multinodular tumor confirmed significantly higher objective response rates in patients receiving DEB as compared with those treated with conventional TACE (P=0.003 and P=0.005, respectively). At the dose of 50 mg doxorubicin, there was no statistically significant difference in liver toxicity between DEB and conventional TACE (P>0.05).
  
  
  CONCLUSIONS
  In Asian patients with HCC, transcatheter treatment with DEB loaded with doxorubicin offers a distinct advantage in objective tumor response rate as compared with conventional, Lipiodol-based TACE regimens.
authors.affiliation: Department of Internal Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
authors.forename: Myeong Jun
authors.initials: MJ
authors.lastname: Song
authors.forename: Chung-Hwa
authors.initials: CH
authors.lastname: Park
authors.forename: Jin Dong
authors.initials: JD
authors.lastname: Kim
authors.forename: Hee Yeon
authors.initials: HY
authors.lastname: Kim
authors.forename: Si Hyun
authors.initials: SH
authors.lastname: Bae
authors.forename: Jong Young
authors.initials: JY
authors.lastname: Choi
authors.forename: Seung Kew
authors.initials: SK
authors.lastname: Yoon
authors.forename: Ho Jong
authors.initials: HJ
authors.lastname: Chun
authors.forename: Byung Gil
authors.initials: BG
authors.lastname: Choi
authors.forename: Hae Giu
authors.initials: HG
authors.lastname: Lee
mesh_terms: D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People / Q000706:statistics & numerical data; D006528:Carcinoma, Hepatocellular / Q000208:ethnology / Q000473:pathology / Q000628:therapy*; D016022:Case-Control Studies; D002406:Catheterization, Peripheral; D016461:Chemoembolization, Therapeutic / Q000009:adverse effects; D016009:Chi-Square Distribution; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D004337:Drug Carriers; D004998:Ethiodized Oil / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006499:Hepatic Artery; D006801:Humans; D007269:Injections, Intra-Arterial; D008113:Liver Neoplasms / Q000208:ethnology / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D056910:Republic of Korea; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D047368:Tumor Burden
chemical_list: D000903:Antibiotics, Antineoplastic; D004337:Drug Carriers; D004998:Ethiodized Oil; D004317:Doxorubicin