A randomized phase II study of autologous cytokine-induced killer cells in treatment of hepatocelluar carcinoma
A randomized phase II study of autologous cytokine-induced killer cells in treatment of hepatocelluar carcinoma
复制标题
自体细胞因子诱导的杀伤细胞治疗肝细胞癌的随机 II 期研究
DOI：
10.1007/s10875-013-9976-0
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发表时间：
2014-02-01
影响因子：
9.1
通讯作者：
Ren, Xiubao
中科院分区：
文献类型：
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作者：
Yu, Xiaozhou;Zhao, Hua;Ren, Xiubao
目的本前瞻性研究旨在探讨细胞因子诱导杀伤细胞（CIK）治疗对肝细胞癌患者的益处，这一点尚未得到充分研究。方法2004年1月至2009年5月，入组132例初诊为巴塞罗那临床肝癌（BCLC）A、B或C期、Child-Pugh评分为A或B级且既往未接受治疗的肝细胞癌患者。患者被随机分配到第 1 组 (n= 66) 接受 CIK 治疗加标准治疗，或第 2 组 (n= 66) 仅接受标准治疗。主要终点是总生存期 (OS)，次要终点是无进展生存期，通过 Kaplan-Meier 分析和 Cox 比例风险模型的治疗风险比进行评估。结果 1 年（OS：74.2% 与 50.0%，95% CI：63.6–84.8% 与 37.8–62.2，p= 0.002）、2 年（OS：53.0% 对比 30.3%，95% CI：40.8–65.2% 对比 19.1–41.5%，p= 0.002），3 年（OS：42.4% 对比 24.2%，95% CI：30.4–54.4% 对比13.8–34.6 %,p= 0.005），第 1 组患者的中位总生存期和无进展生存期显着高于第 2 组。因此，对于不适合手术的患者，CIK 治疗可以获得显着的益处。 CIK的主要不良反应包括发热、过敏和头痛。结论不适合手术的肝细胞癌患者在CIK治疗中表现出更长的总生存期和无进展生存期。
PurposeThis 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.MethodsFrom 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.ResultsThe 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.ConclusionsHepatocellular carcinoma patients who were not suitable for surgery demonstrate prolonged overall and progression-free survival from CIK treatment.