title: Autologous Cytokine-Induced Killer Cells Improves Overall Survival of Metastatic Colorectal Cancer Patients: Results From a Phase II Clinical Trial.
abstract: This randomized clinical study was conducted to evaluate the therapeutic benefits of cytokine-induced killer (CIK) cell immunotherapy in combination with chemotherapy in metastatic colorectal cancer (mCRC) patients.
  
  
  
  Sixty-one patients in group 1 (cell therapy group) received autologous CIK cell immunotherapy in combination with chemotherapy (5-Fluorouridine, leucovorin and oxaliplatin [FOLFOX4] plan). Another 61 patients in group 2 (the control group) received chemotherapy (FOLFOX4 plan) alone. The primary study end points were overall survival (OS) and progression-free survival (PFS). The secondary end points were treatment response and adverse events.
  
  
  
  The 3-year PFS and OS in group 1 were 20% and 48%, respectively, compared with 13% and 23%, respectively, in group 2 (P = .131 and P < .001, respectively). The median OS in group 1 was significantly increased compared with that in group 2 (OS, 36 vs. 16 months; P < .001). Furthermore, there was a trend toward superior PFS in group 1 compared with that in group 2 (PFS, 16 vs. 10 months; P = .072). Using univariate analysis, we found that Karnofsky performance status <80, number of metastases >1, and increased platelet levels were significantly associated with poorer prognosis in group 1. Alternatively, the cycle count of CIK cell treatment was significantly associated with good prognosis in group 1. Toxicity was mild in patients who received CIK therapy.
  
  
  
  This study shows that CIK cell immunotherapy in combination with chemotherapy is well tolerated and improves the OS of mCRC patients.
authors.affiliation: National Clinical Research Center for Cancer, Key Laboratory Cancer and Therapy, Tianjin, PR China; Key Laboratory of Cancer Immunology and Biotherapy, Tianjin, PR China.
authors.forename: Hua
authors.initials: H
authors.lastname: Zhao
authors.affiliation: National Clinical Research Center for Cancer, Key Laboratory Cancer and Therapy, Tianjin, PR China; Key Laboratory of Cancer Immunology and Biotherapy, Tianjin, PR China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Wang
authors.affiliation: National Clinical Research Center for Cancer, Key Laboratory Cancer and Therapy, Tianjin, PR China; Key Laboratory of Cancer Immunology and Biotherapy, Tianjin, PR China.
authors.forename: Jinpu
authors.initials: J
authors.lastname: Yu
authors.affiliation: National Clinical Research Center for Cancer, Key Laboratory Cancer and Therapy, Tianjin, PR China; Key Laboratory of Cancer Immunology and Biotherapy, Tianjin, PR China.
authors.forename: Feng
authors.initials: F
authors.lastname: Wei
authors.affiliation: National Clinical Research Center for Cancer, Key Laboratory Cancer and Therapy, Tianjin, PR China; Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin, PR China.
authors.forename: Shui
authors.initials: S
authors.lastname: Cao
authors.affiliation: National Clinical Research Center for Cancer, Key Laboratory Cancer and Therapy, Tianjin, PR China; Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin, PR China.
authors.forename: Xinwei
authors.initials: X
authors.lastname: Zhang
authors.affiliation: National Clinical Research Center for Cancer, Key Laboratory Cancer and Therapy, Tianjin, PR China; Key Laboratory of Cancer Immunology and Biotherapy, Tianjin, PR China.
authors.forename: Nan
authors.initials: N
authors.lastname: Dong
authors.affiliation: National Clinical Research Center for Cancer, Key Laboratory Cancer and Therapy, Tianjin, PR China; Key Laboratory of Cancer Immunology and Biotherapy, Tianjin, PR China. Electronic address: lihui@tjmuch.com.
authors.forename: Hui
authors.initials: H
authors.lastname: Li
authors.affiliation: National Clinical Research Center for Cancer, Key Laboratory Cancer and Therapy, Tianjin, PR China; Key Laboratory of Cancer Immunology and Biotherapy, Tianjin, PR China; Department of Biotherapy, Tianjin Medical University Cancer Institute and Hospital, Tianjin, PR China. Electronic address: rwziyi@yahoo.com.
authors.forename: Xiubao
authors.initials: X
authors.lastname: Ren
mesh_terms: D000230:Adenocarcinoma / Q000628:therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D019540:Area Under Curve; D015179:Colorectal Neoplasms / Q000628:therapy*; D003131:Combined Modality Therapy / Q000379:methods; D055612:Cytokine-Induced Killer Cells / Q000637:transplantation*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods*; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012372:ROC Curve
keywords: Cytokine-induced killer cell; Immunotherapy; Metastatic colorectal cancer; Overall survival; Progression-free survival