title: Analysis of adverse events following the treatment of autologous cytokine-induced killer cells for adoptive immunotherapy in malignant tumour sufferers.
abstract: BACKGROUND
  Adoptive immune cell transfer such as cytokine-induced killer (CIK) cells has become an important adjuvant approach in patients with tumours.
  
  
  OBJECTIVE
  The aim of this study was to analyse the adverse events (AEs) that occur during the transfusion of autologous CIK cells and to identify the risk factors associated with these AEs.
  
  
  METHODS
  Cell infusion-associated AEs were evaluated according to National Cancer Institute Common Terminology Criteria. Analysis was performed from a single-centre data on 893 malignant tumour patients who received a total of 4088 transfusions from March 2008 to October 2013.
  
  
  RESULTS
  A total of 215/4088 (5.26%) transfusion cases from 893 patients presented with AEs (Grade 1 - 4); 204/215 (94.88%) were Grade 1 - 2, and 156/215 (72.56%) occurred within 24 h. The most common AEs were fever (0.88%), chills (0.56%) and fatigue (0.49%). The rare but severe AEs included anaphylactoid purpura, tumour lysis syndrome, anaphylactic shock, arthralgia. No transfusion-associated death was noticed. The mainly relative risk factors for AEs included transfer cycles and clinical stages.
  
  
  CONCLUSIONS
  This study is a large-sample AEs research, to our knowledge, relative to immune cell transfusion from a single centre data analysis, revealing that autologous CIK cell therapy represents a fairly safe and well-tolerated treatment modality for malignant tumour patients, even rare severe, but not lethal AEs were observed in few patients.
authors.affiliation: College of Life Science, Chinese PLA General Hospital, Biotherapeutic Department , 28 Fuxing Road, HaiDian District, Beijing 100853 , China hanwdrsw69@yahoo.com.
authors.forename: Yajing
authors.initials: Y
authors.lastname: Zhang
authors.forename: Lei
authors.initials: L
authors.lastname: Xia
authors.forename: Yan
authors.initials: Y
authors.lastname: Zhang
authors.forename: Yao
authors.initials: Y
authors.lastname: Wang
authors.forename: Xuechun
authors.initials: X
authors.lastname: Lu
authors.forename: Fengxia
authors.initials: F
authors.lastname: Shi
authors.forename: Yang
authors.initials: Y
authors.lastname: Liu
authors.forename: Meixia
authors.initials: M
authors.lastname: Chen
authors.forename: Kaixhao
authors.initials: K
authors.lastname: Feng
authors.forename: Wenying
authors.initials: W
authors.lastname: Zhang
authors.forename: Xiaobing
authors.initials: X
authors.lastname: Fu
authors.forename: Weidong
authors.initials: W
authors.lastname: Han
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001804:Blood Transfusion, Autologous / Q000009:adverse effects; D055612:Cytokine-Induced Killer Cells / Q000276:immunology / Q000637:transplantation*; D005260:Female; D006801:Humans; D016219:Immunotherapy, Adoptive / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000175:diagnosis* / Q000276:immunology / Q000628:therapy*; D012189:Retrospective Studies; D016896:Treatment Outcome
keywords: adverse events; cytokine-induced killer cells; risk factor; single-centre study