Randomized Study of Autologous Cytokine-Induced Killer Cell Immunotherapy in Metastatic Renal Carcinoma
Randomized Study of Autologous Cytokine-Induced Killer Cell Immunotherapy in Metastatic Renal Carcinoma
复制标题
自体细胞因子诱导杀伤细胞免疫治疗转移性肾癌的随机研究
DOI：
10.1158/1078-0432.ccr-11-2442
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发表时间：
2012-03-15
影响因子：
11.5
通讯作者：
Ren, Xiubao
中科院分区：
文献类型：
--
作者：
Liu, Liang;Zhang, Weihong;Ren, Xiubao
目的：细胞因子诱导的杀伤细胞（CIK）在肾细胞癌（RCC）中的治疗效果尚不清楚。这项前瞻性随机研究旨在评估自体CIK细胞免疫治疗对转移性透明细胞rcc患者的影响。实验设计：从2005年6月到2008年6月，148例转移性透明细胞RCC患者被随机分为自体CIK细胞免疫治疗组（第1组，n = 74），或白细胞介素-2联合IFN-α-2a治疗组（第2组，n = 74）。主要终点是总生存期（OS），次要终点是Kaplan-Meier分析评估的无进展生存期（PFS）和Cox比例风险模型评估的治疗hr。结果：1组3年PFS和OS分别为18%和61%，而2组为12%和23% （P分别= 0.031和<0.001）。1组的中位PFS和OS明显长于2组（PFS， 12个月vs 8个月，P = 0.024； OS， 46个月vs 19个月，P < 0.001）。多因素分析表明，CIK细胞免疫治疗周期计数作为一个连续变量与PFS延长显著相关[HR = 0.88；95%置信区间（CI）， 0.84-0.93；P < 0.001]和OS （HR = 0.58; 95% CI, 0.48-0.69; P < 0.001）。结论：数据提示CIK细胞免疫治疗可改善转移性透明细胞RCC的预后，增加CIK细胞治疗周期计数可进一步增强疗效。临床癌症研究；18 (6);1751 - 9。AACR©2012。
Purpose: The therapeutic benefit of the cytokine-induced killer (CIK) cells was unknown in the renal cell carcinoma (RCC). This prospectively randomized study was conducted to evaluate the effects of autologous CIK cell immunotherapy in patients with metastatic clear cell RCCs. Experimental Design: From June 2005 to June 2008, 148 patients with metastatic clear cell RCC were randomized to autologous CIK cell immunotherapy (arm 1, n = 74), or interleukin-2 treatment combination with IFN-α-2a (arm 2, n = 74). The primary endpoint was overall survival (OS) and secondary endpoint was progression-free survival (PFS) evaluated by Kaplan–Meier analyses and treatment HRs with the Cox proportional hazards model. Results: The 3-year PFS and OS in arm 1 were 18% and 61%, as compared with 12% and 23% in arm 2 (P = 0.031 and <0.001, respectively). The median PFS and OS in arm 1 were significantly longer than those in arm 2 (PFS, 12 vs. 8 months, P = 0.024; OS, 46 vs. 19 months, P < 0.001). Multivariate analyses indicated that the cycle count of CIK cell immunotherapy as a continuous variable was significantly associated with prolonged PFS [HR = 0.88; 95% confidence interval (CI), 0.84-0.93; P < 0.001] and OS (HR = 0.58; 95% CI, 0.48–0.69; P < 0.001) in arm 1. Conclusion: The data suggested that CIK cell immunotherapy could improve the prognosis of metastatic clear cell RCC, and increased cycle count of CIK cell treatment could further enhance the beneficial effects. Clin Cancer Res; 18(6); 1751–9. ©2012 AACR.