title: Prospective evaluation of transcatheter arterial chemoembolization (TACE) with multiple anti-cancer drugs (epirubicin, cisplatin, mitomycin c, 5-fluorouracil) compared with TACE with epirubicin for treatment of hepatocellular carcinoma.
abstract: OBJECTIVE
  To compare the efficacy of transcatheter arterial chemoembolization (TACE) using multiple anticancer drugs (epirubicin, cisplatin, mitomycin C, and 5-furuorouracil: Multi group) with TACE using epirubicin (EP group) for hepatocellular carcinoma (HCC).
  
  
  METHODS
  The study design was a single-center, prospective, randomized controlled trial. Patients with unrespectable HCC confined to the liver, unsuitable for radiofrequency ablation, were assigned to the Multi group or the EP group. We assessed radiographic response as the primary endpoint; secondary endpoints were progression-free survival (PFS), safety, and hepatic branch artery abnormality (Grade I, no damage or mild vessel wall irregularity; Grade II, overt stenosis; Grade III, occlusion; Grades II and III indicated significant hepatic artery damage). A total of 51 patients were enrolled: 24 in the Multi group vs. 27 in the EP group.
  
  
  RESULTS
  No significant difference in HCC patient background was found between the groups. Radiographic response, PFS, and 1- and 2-year overall survival of the Multi vs. EP group were 54% vs. 48%, 6.1 months vs. 8.7 months, and 95% and 65% vs. 85% and 76%, respectively, with no significant difference. Significantly greater Grade 3 transaminase elevation was found in the Multi group (p = 0.023). Hepatic artery abnormality was observed in 34% of the Multi group and in 17.1% of the EP group (p = 0.019).
  
  
  CONCLUSIONS
  TACE with multiple anti-cancer drugs was tolerable but appeared not to contribute to an increase in radiographic response or PFS, and caused significantly more hepatic arterial abnormalities compared with TACE with epirubicin alone.
authors.affiliation: Department of Radiology, Wakayama Medical University, 811-1 Kimiidera, Wakayamashi, Wakayama, 641-8510, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Sahara
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Kawai
authors.forename: Morio
authors.initials: M
authors.lastname: Sato
authors.forename: Takami
authors.initials: T
authors.lastname: Tanaka
authors.forename: Akira
authors.initials: A
authors.lastname: Ikoma
authors.forename: Kouhei
authors.initials: K
authors.lastname: Nakata
authors.forename: Hiroki
authors.initials: H
authors.lastname: Sanda
authors.forename: Hiroki
authors.initials: H
authors.lastname: Minamiguchi
authors.forename: Motoki
authors.initials: M
authors.lastname: Nakai
authors.forename: Shintaro
authors.initials: S
authors.lastname: Shirai
authors.forename: Tetsuo
authors.initials: T
authors.lastname: Sonomura
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000000981:diagnostic imaging / Q000188:drug therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D016009:Chi-Square Distribution; D002945:Cisplatin / Q000008:administration & dosage; D003287:Contrast Media; D023381:Endpoint Determination; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007472:Iohexol; D008111:Liver Function Tests; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D015996:Survival Rate; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
chemical_list: D003287:Contrast Media; D015251:Epirubicin; D007472:Iohexol; D016685:Mitomycin; D002945:Cisplatin; D005472:Fluorouracil