title: Hepatic arterial infusion chemotherapy with fine-powder cisplatin and iodized-oil suspension in patients with intermediate-stage and advanced-stage (Barcelona Clinic Liver Cancer stage-B or stage-C) hepatocellular carcinoma: multicenter phase-II clinical study.
abstract: OBJECTIVE
  This single-arm, multicenter, phase-II trial evaluated the efficacy and safety of hepatic arterial infusion chemotherapy (HAIC) using fine-powder cisplatin and iodized-oil suspension in patients with intermediate- and advanced-stage [Barcelona Clinic Liver Cancer (BCLC) stage-B and stage-C] hepatocellular carcinomas (HCCs).
  
  
  METHODS
  The Institutional Review Board approved this study and patients provided written informed consent. Thirty-five patients (24 men and 11 women, mean 74 ± 6 years [range 60-87 years]) with BCLC stage-B (57 %, 20/35) or stage-C (43 %, 15/35) HCCs who were not candidates for other locoregional treatments were enrolled. HAIC was performed using a suspension of fine-powder cisplatin with a maximum dose of 65 mg/m(2) and iodized oil on demand. The primary endpoint was the response rate evaluated based on Response Evaluation Criteria in Solid Tumor (RECIST) and modified RECIST (mRECIST). Secondary endpoints were overall survival, progression-free survival, and safety.
  
  
  RESULTS
  The initial and best overall response rates at 4 weeks and 3 months, respectively, were 14 and 17 % based on RECIST, and 57 and 23 % based on mRECIST. The median overall and progression-free survival times were 18 and 4 months, respectively. The most frequent grade-3 or grade-4 adverse events were elevation of serum alanine (23 %) and aspartate aminotransferase (20 %), and thrombocytopenia (17 %).
  
  
  CONCLUSIONS
  This HAIC provides promising therapeutic effects with acceptable safety to patients with intermediate-stage and advanced-stage HCCs.
authors.affiliation: Department of Radiology, Mie University School of Medicine, Mie, Japan, takaki-h@clin.medic.mie-u.ac.jp.
authors.forename: Haruyuki
authors.initials: H
authors.lastname: Takaki
authors.forename: Koichiro
authors.initials: K
authors.lastname: Yamakado
authors.forename: Masakatsu
authors.initials: M
authors.lastname: Tsurusaki
authors.forename: Taku
authors.initials: T
authors.lastname: Yasumoto
authors.forename: Yasutaka
authors.initials: Y
authors.lastname: Baba
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Narimatsu
authors.forename: Masashi
authors.initials: M
authors.lastname: Shimohira
authors.forename: Masato
authors.initials: M
authors.lastname: Yamaguchi
authors.forename: Kunihiro
authors.initials: K
authors.lastname: Matsuo
authors.forename: Yoshitaka
authors.initials: Y
authors.lastname: Inaba
authors.forename: Koji
authors.initials: K
authors.lastname: Mikami
authors.forename: Ryohei
authors.initials: R
authors.lastname: Watanabe
authors.forename: Norifumi
authors.initials: N
authors.lastname: Nishida
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Anai
authors.forename: Hideaki
authors.initials: H
authors.lastname: Kakizawa
authors.forename: Shozo
authors.initials: S
authors.lastname: Hirota
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage*; D005260:Female; D006499:Hepatic Artery; D006801:Humans; D007261:Infusions, Intra-Arterial; D007459:Iodized Oil / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011208:Powders; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D011208:Powders; D007459:Iodized Oil; D002945:Cisplatin