title: Phase II study with a combination of epirubicin, cisplatin, UFT, and leucovorin in advanced hepatocellular carcinoma.
abstract: OBJECTIVE
  Hepatocellular carcinoma (HCC) is one of the most common malignancies worldwide. Because HCC usually presents as an advanced disease and occurs in the background of liver cirrhosis, most patients are not suitable for treatment with curative intent, thus effective systemic chemotherapy is required. However, the outcome of systemic chemotherapy has been disappointing in advanced HCC. This study was conducted to test the efficacy and toxicity of the combined regimen of epirubicin, cisplatin, and UFT moderated by leucovorin in advanced or recurrent HCC.
  
  
  METHODS
  All 53 patients received epirubicin (50 mg/m2 i.v.) on day 1 and cisplatin (60 mg/m2 i.v.) after epirubicin administration. Oral UFT 400-600 mg/day, determined by body surface area, and leucovorin 75 mg/day were administered for 21 consecutive days, followed by a 7-day drug free interval.
  
  
  RESULTS
  Nine had a partial response, representing 16.9% of response rate (95% confidence interval rate; 7.0-26.8%) with median response duration of 17.1 weeks (95% CI; 5.0-29.3 weeks, range; 7.1-51.7 weeks). Fifteen patients had stable disease and the disease progressed in 26 patients. The median overall survival for the patients was 24.6 weeks (95% CI; 17.3-31.9 weeks, range; 3.0-131.3 weeks). The main toxicities were hematologic toxicities including neutropenia, which reached grade 3/4 in 17 patients (38.5%), and grade 3 or 4 thrombocytopenia in five patients (9.4%).
  
  
  CONCLUSIONS
  The combination of epirubicin, cisplatin, and UFT moderated by leucovorin showed modest anti-tumor activity with relatively tolerable toxicities. However, a randomized phase III trial based on this regimen is warranted to clarify its survival benefit in patients with advanced HCC.
authors.affiliation: Division of Hematology/Oncology Department of Internal Medicine, Korea University Medical Center, 126-1, Anam-dong 5-ga, Sungbuk-ku, Seoul, 136-705, Korea.
authors.forename: Seok Jin
authors.initials: SJ
authors.lastname: Kim
authors.forename: Hee Yun
authors.initials: HY
authors.lastname: Seo
authors.forename: Jong Gwon
authors.initials: JG
authors.lastname: Choi
authors.forename: Hye Ryoung
authors.initials: HR
authors.lastname: Sul
authors.forename: Hwa Jung
authors.initials: HJ
authors.lastname: Sung
authors.forename: Kyong Hwa
authors.initials: KH
authors.lastname: Park
authors.forename: In Keun
authors.initials: IK
authors.lastname: Choi
authors.forename: Sang Cheul
authors.initials: SC
authors.lastname: Oh
authors.forename: So Young
authors.initials: SY
authors.lastname: Yoon
authors.forename: Jae Hong
authors.initials: JH
authors.lastname: Seo
authors.forename: Chul Won
authors.initials: CW
authors.lastname: Choi
authors.forename: Byung Soo
authors.initials: BS
authors.lastname: Kim
authors.forename: Sang Won
authors.initials: SW
authors.lastname: Shin
authors.forename: Yeul Hong
authors.initials: YH
authors.lastname: Kim
authors.forename: Jun Suk
authors.initials: JS
authors.lastname: Kim
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D000931:Antidotes / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000000981:diagnostic imaging / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006402:Hematologic Diseases / Q000097:blood / Q000139:chemically induced; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008113:Liver Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D014498:Uracil / Q000008:administration & dosage
chemical_list: D000903:Antibiotics, Antineoplastic; D000931:Antidotes; D000970:Antineoplastic Agents; D005641:Tegafur; D015251:Epirubicin; D014498:Uracil; D002945:Cisplatin; D002955:Leucovorin