A randomized phase II study of autologous cytokine-induced killer cells in treatment of hepatocelluar carcinoma |
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Authors: | Xiaozhou Yu Hua Zhao Liang Liu Shui Cao Baozhu Ren Naining Zhang Xiumei An Jinpu Yu Hui Li Xiubao Ren |
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Institution: | 1. Department of Immunology, Tianjin Medical University Cancer Institute & Hospital, Tianjin, China 2. National Clinical Research Center of Cancer, Tianjin, China 3. Key Laboratory of Cancer Immunology and Biotherapy, Tianjin, China
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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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