title: [Multicenter phase II clinical trial of arsenic trioxide injection in the treatment of primary hepatocarcinoma].
abstract: OBJECTIVE
  To evaluate the effect and adverse effects of arsenic trioxide (As2O3) in the treatment of primary hepatocarcinoma patients, and conduct the pharmacokinetics study.
  
  
  METHODS
  A total of one hundred and eleven advanced primary hepatocarcinoma patients in five centers were treated with As2O3 injection 7 - 8 mg/m(2) i.v. qd for 14 days and was repeated after 7 - 14 days. Evaluation of the clinical response and adverse effects was conducted after two cycles of treatment. The patient who had reached partial PR and SD was treated continuously until disease progression or intolerance.
  
  
  RESULTS
  Among the 102 patients evaluable for clinical efficacy analysis, there were 7 PR, 71 SD and 24 PD, the response rate was 6.9% and the clinical benefit rate was 76.5%. The quality of life was improved in 22.5% of patients. The pain relief rate was 71.7%, time to progress (TTP) was 97 days, and the median survival time (MST) was 195 days. The major adverse effects were reversible WHO I-II grade gastrointestinal reactions and bone marrow suppression. The results of pharmacokinetic study showed that the distribution and elimination characteristics in vivo was found to be a two-compartment model. The plasma elimination half-life was (23.94 ± 18.39) h.
  
  
  CONCLUSIONS
  As2O3 is effective in the management of primary hepatocarcinoma, with a significant analgesic effect. To some extent, it can extend TTP and MST in advanced liver cancer patients, while the treatment is well tolerated in the majority of patients.
authors.affiliation: Department of Medical Oncology, Chinese Academy of Medical Sciences, Beijing, China.
authors.forename: Feng-lian
authors.initials: FL
authors.lastname: Qu
authors.forename: Xue-zhi
authors.initials: XZ
authors.lastname: Hao
authors.forename: Shu-kui
authors.initials: SK
authors.lastname: Qin
authors.forename: Ji-wei
authors.initials: JW
authors.lastname: Liu
authors.forename: Guang-jie
authors.initials: GJ
authors.lastname: Sui
authors.forename: Qiang
authors.initials: Q
authors.lastname: Chen
authors.forename: Tao
authors.initials: T
authors.lastname: Qu
authors.forename: He-ping
authors.initials: HP
authors.lastname: Zhang
authors.forename: Yan
authors.initials: Y
authors.lastname: Sun
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D000077237:Arsenic Trioxide; D001152:Arsenicals / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006207:Half-Life; D006801:Humans; D007267:Injections; D007970:Leukopenia / Q000139:chemically induced; D008113:Liver Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009367:Neoplasm Staging; D010087:Oxides / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011788:Quality of Life; D012074:Remission Induction; D015996:Survival Rate; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000970:Antineoplastic Agents; D001152:Arsenicals; D010087:Oxides; D000077237:Arsenic Trioxide