title: A randomized comparative study of high-dose and low-dose hepatic arterial infusion chemotherapy for intractable, advanced hepatocellular carcinoma.
abstract: OBJECTIVE
  Hepatic arterial infusion chemotherapy (HAIC) has been reported to be effective in patients with advanced hepatocellular carcinoma (HCC).
  
  
  METHODS
  In this multicenter, prospective, open-labeled, clinical trial, we randomly assigned 68 patients with advanced HCC to receive either low-dose [n = 32, 5-fluorouracil (FU), 170 mg/m(2) and cisplatin, 7 mg/m(2) on days 1-5] or high-dose HAIC (n = 36, 5-FU, 500 mg/m(2) on days 1-3 and cisplatin, 60 mg/m(2) on day 2) every 4 weeks via an implantable port system.
  
  
  RESULTS
  A total of 207 cycles of HAIC was given to the 68 patients. Overall, 6 patients (8.8%) achieved a partial response and 21 patients (30.9%) had stable disease. The objective response rate (CR + PR) was significantly improved in the high-dose group compared to the low-dose group (16.7% vs. 0%, P = 0.024). The median time to disease progression and overall survival were slightly prolonged in the high-dose group compared to the low-dose group (median survival, 193 vs. 153 days; P = 0.108; median time to disease progression, 145 vs. 90 days; P = 0.095). Multivariate analysis showed that tumor response to treatment [P = 0.007, RR 2.27 (95% CI, 1.248-4.132)] was the only factor associated with overall survival. All adverse events were tolerable and successfully managed in both treatment groups.
  
  
  CONCLUSIONS
  Both HAIC regimens are safe and effective in patients with advanced HCC. High-dose HAIC achieves a better tumor response compared to low-dose HAIC.
authors.affiliation: Department of Internal Medicine, College of Medicine, Pusan National University, Busan, Korea.
authors.forename: Hyun Young
authors.initials: HY
authors.lastname: Woo
authors.forename: Si Hyun
authors.initials: SH
authors.lastname: Bae
authors.forename: Jun Yong
authors.initials: JY
authors.lastname: Park
authors.forename: Kwang Hyub
authors.initials: KH
authors.lastname: Han
authors.forename: Ho Jong
authors.initials: HJ
authors.lastname: Chun
authors.forename: Byung Gil
authors.initials: BG
authors.lastname: Choi
authors.forename: Hyeon U
authors.initials: HU
authors.lastname: Im
authors.forename: Jong Young
authors.initials: JY
authors.lastname: Choi
authors.forename: Seung Kew
authors.initials: SK
authors.lastname: Yoon
authors.forename: Jae Youn
authors.initials: JY
authors.lastname: Cheong
authors.forename: Sung Won
authors.initials: SW
authors.lastname: Cho
authors.forename: Byoung Kuk
authors.initials: BK
authors.lastname: Jang
authors.forename: Jae Seok
authors.initials: JS
authors.lastname: Hwang
authors.forename: Sang Gyune
authors.initials: SG
authors.lastname: Kim
authors.forename: Young Seok
authors.initials: YS
authors.lastname: Kim
authors.forename: Yeon Seok
authors.initials: YS
authors.lastname: Seo
authors.forename: Hyung Joon
authors.initials: HJ
authors.lastname: Yim
authors.forename: Soon Ho
authors.initials: SH
authors.lastname: Um
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006499:Hepatic Artery; D006801:Humans; D007261:Infusions, Intra-Arterial; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate
chemical_list: D002945:Cisplatin; D005472:Fluorouracil