Sustained efficacy of adjuvant immunotherapy with cytokine-induced killer cells for hepatocellular carcinoma: an extended 5-year follow-up.
Sustained efficacy of adjuvant immunotherapy with cytokine-induced killer cells for hepatocellular carcinoma: an extended 5-year follow-up.
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DOI：
10.1007/s00262-018-2247-4
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发表时间：
2019-01
期刊：
影响因子：
--
通讯作者：
Yoon JH
中科院分区：
文献类型：
--
作者：
Lee JH;Lee JH;Lim YS;Yeon JE;Song TJ;Yu SJ;Gwak GY;Kim KM;Kim YJ;Lee JW;Yoon JH
我们早期的多中心随机对照试验表明，细胞因子诱导的杀伤(CIK)细胞辅助免疫治疗可以延长接受肝细胞癌(HCC)根治性治疗的患者的无复发生存期(RFS)和总生存期(OS)。在本研究中，我们确定在重复注射CIK细胞结束后，CIK细胞治疗的疗效是否继续。我们对之前的试验进行了后续研究。其中免疫治疗组114例(注射6.4 × 109CIK细胞，60周内共注射16次)和对照组(未治疗)112例。总共有162名患者(免疫治疗组的和73名对照组)在最后一名患者随机分组后接受了60个月的延长随访。主端点是RFS，次要端点包括OS。在中位数68.5月(四分位数范围45.0~82.2月)的随访期间，免疫组的复发或死亡风险继续显著降低[风险比(HR)0.67；95%可信区间(CI)0.48~0.94；P = 0.009经单侧对数等级检验]。5年时，免疫组RFS率为44.8%，对照组为33.1%。免疫治疗组全因死亡的风险也低于对照组(HR0.33；95%CI 0.15~0.76；P = 0.006)。在接受根治性治疗的肝癌患者中，由于辅助性CIK细胞免疫治疗而导致的RFS和OS的显著改善持续了5年多，没有任何促进作用。本文的在线版本(10.1007/s00262-0182247-4)包含补充材料，可供授权用户使用。
Our earlier multicenter randomized controlled trial showed that adjuvant immunotherapy with cytokine-induced killer (CIK) cells resulted in longer recurrence-free survival (RFS) and overall survival (OS) as well in patients who received curative treatment for hepatocellular carcinoma (HCC). In the present study, we determined if the efficacy of CIK cell therapy continued after end of repeated CIK cell injections. We performed a follow-up study of our preceding trial. We included 226 patients: 114 patients in the immunotherapy group (injection of 6.4 × 109 CIK cells, 16 times during 60 weeks) and 112 patients in the control group (no treatment) after potentially curative treatment for HCC. In total, 162 patients (89 of the immunotherapy group and 73 of controls) underwent an extended follow-up for 60 months after randomization of the last patient. The primary endpoint was RFS, and secondary endpoints included OS. During follow-up time of median 68.5 months (interquartile range 45.0–82.2 months), the immunotherapy group continued to show a significantly lower risk of recurrence or death [hazard ratio (HR) 0.67; 95% confidence interval (CI) 0.48–0.94; P = 0.009 by one-sided log-rank test]. At 5 years, RFS rate was 44.8% in the immunotherapy group and 33.1% in the control group. The risk of all-cause death was also lower in the immunotherapy group compared to the control group (HR 0.33; 95% CI 0.15–0.76; P = 0.006). In patients who received curative treatment for HCC, the significant improvement in RFS and OS as a result of adjuvant CIK cell immunotherapy lasted over 5 years without boosting. The online version of this article (10.1007/s00262-018-2247-4) contains supplementary material, which is available to authorized users.
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