title: Roles played by chemolipiodolization and embolization in chemoembolization for hepatocellular carcinoma: single-blind, randomized trial.
abstract: BACKGROUND
  The aim of our study was to compare the efficacy and safety of: 1) transarterial chemolipiodolization with gelatin sponge embolization vs chemolipiodolization without embolization, and 2) chemolipiodolization with triple chemotherapeutic agents vs epirubicin alone.
  
  
  METHODS
  A single-blind, three parallel arm, randomized trial was conducted at three clinical centers with patients with biopsy-confirmed unresectable hepatocellular carcinoma. Arm 1 received triple-drug chemolipiodolization and sponge embolization, whereas Arm 2 received triple-drug chemolipiodolization only. Patients in arm 3 were treated with single-drug chemolipiodolization and sponge embolization. We compared overall survival and time to progression. Event-time distributions were estimated by the Kaplan-Meier method. All statistical tests were two-sided.
  
  
  RESULTS
  From July 2007 to November 2009, 365 patients (Arm 1: n = 122; Arm 2: n = 121; Arm 3: n = 122) were recruited. The median tumor size was 10.9cm (range = 7-22cm), and 34.5% had macrovascular invasion. The median survivals and time to progression in Arm 1, Arm 2, and Arm 3 were 10.5 and 3.6 months, 10.1 and 3.1 months, and 5.9 and 3.1 months, respectively. Survival was statistically significantly better in Arm 1 than in Arm 3 (P < .001), whereas there was no statistically significant difference between Arm 1 and Arm 2 (P = .20). Objective response rates were 45.9%, 29.7%, and 18.9% for Arm 1, Arm 2, and Arm 3, respectively.
  
  
  CONCLUSIONS
  Chemolipiodolization played an important role in transarterial chemoembolization, and the choice of chemotherapy regimen may largely affect survival outcomes. However, the removal of embolization from chemoembolization might not statistically significantly decrease survival.
authors.affiliation: Department of Hepatobiliary Oncology, Cancer Center, Sun Yat-sen University, Guangzhou, P.R. China. shiming@sysu.edu.cn
authors.forename: Ming
authors.initials: M
authors.lastname: Shi
authors.forename: Li-Gong
authors.initials: LG
authors.lastname: Lu
authors.forename: Wan-Qiang
authors.initials: WQ
authors.lastname: Fang
authors.forename: Rong-Ping
authors.initials: RP
authors.lastname: Guo
authors.forename: Min-Shan
authors.initials: MS
authors.lastname: Chen
authors.forename: Yong
authors.initials: Y
authors.lastname: Li
authors.forename: Jun
authors.initials: J
authors.lastname: Luo
authors.forename: Li
authors.initials: L
authors.lastname: Xu
authors.forename: Ru-Hai
authors.initials: RH
authors.lastname: Zou
authors.forename: Xiao-Jun
authors.initials: XJ
authors.lastname: Lin
authors.forename: Ya-Qi
authors.initials: YQ
authors.lastname: Zhang
mesh_terms: D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000970:Antineoplastic Agents; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D016461:Chemoembolization, Therapeutic / Q000379:methods; D002681:China; D003503:Cyclobutanes / Q000008:administration & dosage; D018572:Disease-Free Survival; D004621:Embolization, Therapeutic / Q000379:methods*; D015251:Epirubicin / Q000008:administration & dosage; D004998:Ethiodized Oil / Q000627:therapeutic use*; D005260:Female; D005781:Gelatin Sponge, Absorbable / Q000627:therapeutic use; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D016037:Single-Blind Method; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D003503:Cyclobutanes; D009944:Organoplatinum Compounds; D015251:Epirubicin; D016685:Mitomycin; D004998:Ethiodized Oil; C066228:lobaplatin