title: Autologous cytokine-induced killer cell immunotherapy in lung cancer: a phase II clinical study.
abstract: OBJECTIVE
  Cytokine-induced killer (CIK) cells have the ability to kill tumor in vitro and in vivo. This study was designed to evaluate the clinical efficacy of CIK cell immunotherapy following regular chemotherapy in patients with non-small cell lung cancer (NSCLC) after surgery.
  
  
  METHODS
  A paired study, with 87 stage I-IV NSCLC patients in each group, was performed. Patients received either chemotherapy (arm 2) or chemotherapy in combination with autologous CIK cell immunotherapy (arm 1). Progression-free survival (PFS) and overall survival (OS) were evaluated.
  
  
  RESULTS
  Of the 87 paired patients, 50 had early-stage disease (stage I-IIIA) and 37 had advanced-stage disease (stage IIIB-IV). Among early-stage patients, the distribution of 3-year PFS rate and median PFS time showed no statistical difference between the two groups (p = 0.259 and 0.093, respectively); however, the 3-year OS rate and median OS time in arm 1 were significantly higher than those in arm 2 (82 vs. 66 %; p = 0.049 and 73 vs. 53 months; p = 0.006, respectively). Among the advanced-stage patients, the 3-year PFS and OS rates of arm 1 were significantly higher than those of arm 2 (6 vs. 3 %; p < 0.001 and 31 vs. 3 %; p < 0.001, respectively); the median PFS and OS times in arm 1 were also significantly longer than those in arm 2 (13 vs. 6 months; p = 0.001 and 24 vs. 10 months; p < 0.001, respectively). Multivariate analyses indicated that the frequency of CIK cell immunotherapy was significantly associated with prolonged PFS (HR = 0.91; 95 % CI 0.85-0.98; p = 0.012) and OS (HR = 0.83; 95 % CI, 0.74-0.93; p = 0.001) in the arm 1.
  
  
  CONCLUSIONS
  The data suggested that CIK cell immunotherapy could improve the efficacy of conventional chemotherapy in NSCLC patients, and increased frequency of CIK cell treatment could further enhance the beneficial effects. A multi-center randomized trial is being carried out in our hospital to further validate these findings.
authors.affiliation: Department of Immunology, Tianjin Medical University Cancer Institute and Hospital, Huanhu Xi Road, Hexi District, Tianjin, 300060, China.
authors.forename: Runmei
authors.initials: R
authors.lastname: Li
authors.forename: Changli
authors.initials: C
authors.lastname: Wang
authors.forename: Liang
authors.initials: L
authors.lastname: Liu
authors.forename: Chunjuan
authors.initials: C
authors.lastname: Du
authors.forename: Shui
authors.initials: S
authors.lastname: Cao
authors.forename: Jinpu
authors.initials: J
authors.lastname: Yu
authors.forename: Shizhen Emily
authors.initials: SE
authors.lastname: Wang
authors.forename: Xishan
authors.initials: X
authors.lastname: Hao
authors.forename: Xiubao
authors.initials: X
authors.lastname: Ren
authors.forename: Hui
authors.initials: H
authors.lastname: Li
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000628:therapy*; D055612:Cytokine-Induced Killer Cells / Q000637:transplantation*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D016219:Immunotherapy, Adoptive / Q000379:methods*; D008175:Lung Neoplasms / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents