title: Single-Agent versus Combination Doxorubicin-Based Transarterial Chemoembolization in the Treatment of Hepatocellular Carcinoma: A Single-Blind, Randomized, Phase II Trial.
abstract: OBJECTIVE
  It was the aim of this study to find an optimal therapeutic regimen of transarterial chemoembolization (TACE) by comparing the efficacy of chemoembolization with different anticancer agents in hepatocellular carcinoma (HCC) patients.
  
  
  METHODS
  A single-blind, three-group parallel, randomized trial was conducted in Guangdong General Hospital, Guangzhou, China, with patients with biopsy-confirmed HCC. Group 1 received single-drug (doxorubicin) chemoembolization, while group 2 received double-drug (doxorubicin and mitomycin C) chemoembolization. Patients in group 3 were treated with triple-drug (doxorubicin, mitomycin C, and gemcitabine) chemoembolization. Lipiodol was used as embolization agent in all protocols. We compared the overall survival (OS), time to progression (TTP), and objective response rate (ORR) between groups. Response assessment was performed according to modified RECIST (Response Evaluation Criteria In Solid Tumors) criteria.
  
  
  RESULTS
  Between January 2008 and January 2011, 162 patients (group 1, n = 50; group 2, n = 59; group 3, n = 53) were recruited. The OS and TTP in groups 1, 2, and 3 were 14.9 and 6.4, 13.2 and 6.4, and 20.5 and 6.8 months, respectively. OS and TTP were statistically significant among groups (p = 0.002 and p = 0.037). The ORR was 22.0, 40.7, and 56.6%, respectively. The ORR was significantly different across the three groups (p < 0.002).
  
  
  CONCLUSIONS
  TACE with multiple chemotherapeutic agents might significantly increase survival and tumor response; additionally, gemcitabine was likely to have an advantage in improving the prognosis of HCC patients. © 2015 S. Karger AG, Basel.
authors.affiliation: Guangdong Cardiovascular Institute, Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
authors.forename: Bing
authors.initials: B
authors.lastname: Liu
authors.forename: Jian-wen
authors.initials: JW
authors.lastname: Huang
authors.forename: Yong
authors.initials: Y
authors.lastname: Li
authors.forename: Bao-shan
authors.initials: BS
authors.lastname: Hu
authors.forename: Xu
authors.initials: X
authors.lastname: He
authors.forename: Wei
authors.initials: W
authors.lastname: Zhao
authors.forename: You-bing
authors.initials: YB
authors.lastname: Zheng
authors.forename: Li-gong
authors.initials: LG
authors.lastname: Lu
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D016461:Chemoembolization, Therapeutic / Q000379:methods*; D002681:China; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006499:Hepatic Artery; D006801:Humans; D053208:Kaplan-Meier Estimate; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D011379:Prognosis; D016037:Single-Blind Method; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D016685:Mitomycin; D004317:Doxorubicin; D000093542:Gemcitabine