title: Phase II study of the efficacy and safety of cisplatin-epinephrine injectable gel administered to patients with unresectable hepatocellular carcinoma.
abstract: OBJECTIVE
  To study the efficacy and safety of percutaneous cisplatin-epinephrine (CDDP-EPI) injectable gel in patients with localized unresectable hepatocellular carcinoma (HCC).
  
  
  METHODS
  Eligible patients had histologically proven HCC, no prior treatment except for surgery, and no more than three tumors (each measured < or = 7 cm, total tumor volume < or = 200 cm(3)). They were treated percutaneously under ultrasound or computed tomography (CT) guidance, with up to 10 mL of CDDP-EPI gel (1 mL contains 4 mg of CDDP and 0.1 mg of EPI) per treatment and four treatments in 6 weeks to a maximum of eight treatments. The primary end points were tumor response, defined by change of percentage of tumor necrosis according to CT criteria, and safety. Survival parameters were secondary end points.
  
  
  RESULTS
  From June 1997 to April 2000, 58 patients (median age, 65 years) entered the study. All patients were assessable for safety, and 51 were assessable for efficacy. The median number of treatments was four (range, one to eight treatments). Objective response rate was 53% (27 of 51 patients), including 16 complete and 11 partial responses. Of the 27 responders, 14 (52%) subsequently developed progressive disease, but in most of them (93%), a new tumor arose at untreated liver sites. Median survival was 27 months (range, 18.4 to 35.7 months). The 1-, 2-, and 3-year survival rates were 79%, 56%, and 14% respectively. The procedure was well tolerated with only minor side effects.
  
  
  CONCLUSIONS
  Percutaneous local ablation with CDDP-EPI injectable gel can induce significant tumor necrosis and local control for localized unresectable HCC, and the treatment is well tolerated.
authors.affiliation: Department of Clinical Oncology, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, New Territories, Hong Kong SAR, China. waitongleung@cuhk.edu.hk
authors.forename: T W T
authors.initials: TW
authors.lastname: Leung
authors.forename: S
authors.initials: S
authors.lastname: Yu
authors.forename: P J
authors.initials: PJ
authors.lastname: Johnson
authors.forename: J
authors.initials: J
authors.lastname: Geschwind
authors.forename: T J
authors.initials: TJ
authors.lastname: Vogl
authors.forename: K
authors.initials: K
authors.lastname: Engelmann
authors.forename: G J
authors.initials: GJ
authors.lastname: Gores
authors.forename: M
authors.initials: M
authors.lastname: Giovannini
authors.forename: J
authors.initials: J
authors.lastname: O'Grady
authors.forename: M
authors.initials: M
authors.lastname: Heneghan
authors.forename: M
authors.initials: M
authors.lastname: Stewart
authors.forename: E K
authors.initials: EK
authors.lastname: Orenberg
authors.forename: P J
authors.initials: PJ
authors.lastname: Thuluvath
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004338:Drug Combinations; D004837:Epinephrine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005782:Gels; D006801:Humans; D015552:Injections, Intralesional; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D004338:Drug Combinations; D005782:Gels; D002945:Cisplatin; D004837:Epinephrine