title: A phase I/II trial of chemoembolization for hepatocellular carcinoma using a novel intra-arterial drug-eluting bead.
abstract: OBJECTIVE
  To assess the safety and efficacy of transarterial chemoembolization (TACE) using doxorubicin-eluting beads (DEB) for hepatocellular carcinoma (HCC).
  
  
  METHODS
  Patients with incurable HCC and Child-Pugh class A cirrhosis were considered eligible for this phase I/II trial. Two courses of TACE using DEB were given at an interval of 2 months, and tumor response was assessed by computerized tomography scan. The phase I trial was a dose-escalating study starting from 25 mg to 150 mg doxorubicin in cohorts of 3 patients. The 150-mg doxorubicin dose was used for the phase II study. Primary end points were treatment-related complications and deaths. Secondary end points included tumor response and pharmacokinetics of doxorubicin.
  
  
  RESULTS
  In the phase I study involving 15 patients, no dose-limiting toxicity was observed for up to 150 mg doxorubicin, which was used for 20 patients in the phase II study. The pharmacokinetic study showed a low peak plasma doxorubicin concentration (49.4 +/- 23.7 ng/mL), and no systemic toxicity was observed. The treatment-related complication rate was 11.4%. There was no treatment-related death. Among 30 patients who completed 2 courses of TACE, the partial response rate and the complete response rates were 50% and 0%, respectively, by response evaluation criteria in solid tumors (RECIST) criteria at computerized tomography scan 1 month after the second TACE. By modified RECIST criteria, taking into account the extent of tumor necrosis, 19 (63.3%) patients had a partial response and 2 (6.7%) had a complete response.
  
  
  CONCLUSIONS
  This study shows that TACE using DEB is a safe and effective treatment for HCC, supporting a phase III randomized trial to compare this novel treatment with conventional TACE using doxorubicin-Lipiodol emulsion.
authors.affiliation: Department of Surgery, The University of Hong Kong, Queen Mary Hospital, Hong Kong, China.
authors.forename: Ronnie T P
authors.initials: RT
authors.lastname: Poon
authors.forename: Wai Kuen
authors.initials: WK
authors.lastname: Tso
authors.forename: Roberta W C
authors.initials: RW
authors.lastname: Pang
authors.forename: Kelvin K C
authors.initials: KK
authors.lastname: Ng
authors.forename: Regina
authors.initials: R
authors.lastname: Woo
authors.forename: Kin Shing
authors.initials: KS
authors.lastname: Tai
authors.forename: Sheung Tat
authors.initials: ST
authors.lastname: Fan
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D002851:Chromatography, High Pressure Liquid; D003287:Contrast Media / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage* / Q000493:pharmacokinetics; D004338:Drug Combinations; D005260:Female; D005500:Follow-Up Studies; D006499:Hepatic Artery; D006801:Humans; D007269:Injections, Intra-Arterial; D007459:Iodized Oil / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D003287:Contrast Media; D004338:Drug Combinations; D007459:Iodized Oil; D004317:Doxorubicin