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A randomized phase II study of autologous cytokine-induced killer cells in treatment of hepatocelluar carcinoma

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Abstract

Purpose

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.

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Acknowledgments

We thank Dr. Shizhen Emily Wang, from the Division of Tumor Cell Biology, Beckman Research Institute of City of Hope for providing help and assistance with this study. This project was supported by grants from the National Basic Research Program of China (973 program) (No. 2012CB9333004) and National Natural Science Funds (No. 81171983 and 30901754). The authors declare that they have no conflicts of interest.

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Authors and Affiliations

  1. Department of Immunology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China

    Xiaozhou Yu, Hua Zhao, Liang Liu, Shui Cao, Baozhu Ren, Naining Zhang, Xiumei An, Jinpu Yu, Hui Li & Xiubao Ren

  2. National Clinical Research Center of Cancer, Tianjin, China

    Xiaozhou Yu, Hua Zhao, Liang Liu, Shui Cao, Baozhu Ren, Naining Zhang, Xiumei An, Jinpu Yu, Hui Li & Xiubao Ren

  3. Key Laboratory of Cancer Immunology and Biotherapy, Tianjin, China

    Xiaozhou Yu, Hua Zhao, Liang Liu, Shui Cao, Baozhu Ren, Naining Zhang, Xiumei An, Jinpu Yu, Hui Li & Xiubao Ren

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  1. Xiaozhou Yu
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Correspondence to Hui Li or Xiubao Ren.

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Xiaozhou Yu and Hua Zhao these authors contributed equally to this manuscript.

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Yu, X., Zhao, H., Liu, L. et al. A randomized phase II study of autologous cytokine-induced killer cells in treatment of hepatocelluar carcinoma. J Clin Immunol 34, 194–203 (2014). https://doi.org/10.1007/s10875-013-9976-0

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  • DOI: https://doi.org/10.1007/s10875-013-9976-0

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