title: A randomized phase II study of autologous cytokine-induced killer cells in treatment of hepatocellular carcinoma.
abstract: OBJECTIVE
  This prospective study aims to explore the benefit of cytokine-induced killer cell (CIK) treatment in hepatocellular carcinoma patients, which has not yet been thoroughly studied before.
  
  
  METHODS
  From January 2004 to May 2009, 132 patients who were initially diagnosed with hepatocellular carcinoma of Barcelona Clinic Liver Cancer (BCLC) stage A, B or C, Child-Pugh scores of A or B and without prior treatment were enrolled in the study. Patients were randomly assigned to either arm 1 (n = 66) to receive CIK treatment plus standard treatment, or arm 2 (n = 66) to receive standard treatment only. The primary end point was overall survival (OS) and the secondary endpoint was progression-free survival as evaluated by Kaplan-Meier analyses and treatment hazard ratios with the Cox proportional hazards model.
  
  
  RESULTS
  The 1-year (OS: 74.2% vs. 50.0%, 95% CI: 63.6-84.8% vs. 37.8-62.2, p = 0.002), 2-year (OS: 53.0% vs. 30.3%, 95% CI: 40.8-65.2% vs. 19.1-41.5%, p = 0.002), 3-year (OS: 42.4% vs. 24.2%, 95% CI: 30.4-54.4% vs. 13.8-34.6%, p = 0.005) and median overall and progression-free survivals of arm 1 patients were significantly higher than those of arm 2. Therefore, in patients who are not suitable for surgery, significant benefit is obtained from CIK treatment. The main adverse effects of CIK included fever, allergy and headache pain.
  
  
  CONCLUSIONS
  Hepatocellular carcinoma patients who were not suitable for surgery demonstrate prolonged overall and progression-free survival from CIK treatment.
authors: Department of Immunology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China.
authors: Xiaozhou
authors: X
authors: Yu
authors: Hua
authors: H
authors: Zhao
authors: Liang
authors: L
authors: Liu
authors: Shui
authors: S
authors: Cao
authors: Baozhu
authors: B
authors: Ren
authors: Naining
authors: N
authors: Zhang
authors: Xiumei
authors: X
authors: An
authors: Jinpu
authors: J
authors: Yu
authors: Hui
authors: H
authors: Li
authors: Xiubao
authors: X
authors: Ren
mesh_terms: D000328:Adult; D000368:Aged; D006528:Carcinoma, Hepatocellular / Q000276:immunology* / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D055612:Cytokine-Induced Killer Cells / Q000276:immunology* / Q000378:metabolism; D003602:Cytotoxicity, Immunologic; D005260:Female; D006801:Humans; D016130:Immunophenotyping; D016219:Immunotherapy, Adoptive / Q000009:adverse effects; D008113:Liver Neoplasms / Q000276:immunology* / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D011379:Prognosis; D016896:Treatment Outcome; D047368:Tumor Burden