title: A phase II trial of transcatheter arterial infusion chemotherapy with an epirubicin-Lipiodol emulsion for advanced hepatocellular carcinoma refractory to transcatheter arterial embolization.
abstract: BACKGROUND
  Transcatheter arterial embolization (TAE) has been recognized as an effective palliative treatment option for advanced hepatocellular carcinoma (HCC). However, no effective alternative treatments for TAE-refractory HCC have yet been established. The aim of this study was to evaluate the antitumor activity and toxicity of transcatheter arterial infusion chemotherapy using an epirubicin-Lipiodol emulsion in patients with TAE-refractory HCC.
  
  
  METHODS
  Patients with TAE-refractory HCC were enrolled. A dose of 60 mg/m(2) epirubicin emulsified in Lipiodol and contrast medium was administered from the feeding artery of the HCC. Treatment was repeated every 4 to 12 weeks if there was no evidence of tumor progression or unacceptable toxicity.
  
  
  RESULTS
  Twenty patients were enrolled in this trial. The median number of treatment courses was 1 (range 1-4). Among the enrolled patients, one (5%) achieved a partial response, and three (15%) showed a minor response. Five (25%) patients had no change and 11 (55%) showed progressive disease. The median survival time, 1-year survival rate and median progression-free survival time for the patients as a whole were 12.4 months, 52.6%, and 1.1 months, respectively. The main grade 3 and 4 toxicities were leukocytopenia (35%), neutropenia (65%), thrombocytopenia (30%), and elevations of the aspartate aminotransferase (45%) and alanine aminotransferase (35%) levels. These toxicities were generally brief and reversible.
  
  
  CONCLUSIONS
  Transcatheter arterial infusion chemotherapy with an epirubicin-Lipiodol emulsion appears to have only modest activity with moderate toxicity for treatment of patients with TAE-refractory HCC. These findings do not support its use in practice, and further studies with the same regimen in patients with TAE-refractory HCC are not recommended.
authors.affiliation: Hepatobiliary and Pancreatic Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Tanaka
authors.forename: Masafumi
authors.initials: M
authors.lastname: Ikeda
authors.forename: Takuji
authors.initials: T
authors.lastname: Okusaka
authors.forename: Hideki
authors.initials: H
authors.lastname: Ueno
authors.forename: Chigusa
authors.initials: C
authors.lastname: Morizane
authors.forename: Takashi
authors.initials: T
authors.lastname: Ogura
authors.forename: Atsushi
authors.initials: A
authors.lastname: Hagihara
authors.forename: Satoru
authors.initials: S
authors.lastname: Iwasa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D002406:Catheterization, Peripheral; D018572:Disease-Free Survival; D004621:Embolization, Therapeutic; D004655:Emulsions; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007261:Infusions, Intra-Arterial; D007459:Iodized Oil / Q000008:administration & dosage / Q000627:therapeutic use*; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D000509:alpha-Fetoproteins / Q000378:metabolism
chemical_list: D000903:Antibiotics, Antineoplastic; D004655:Emulsions; D000509:alpha-Fetoproteins; D015251:Epirubicin; D007459:Iodized Oil