自体细胞因子诱导的杀伤细胞免疫治疗转移性肾细胞癌的随机研究。

Randomized study of autologous cytokine-induced killer cell immunotherapy in metastatic renal carcinoma.

机构信息

Department of Biotherapy, Tianjin Medical University Cancer Institute & Hospital, Tampa, FL, USA.

出版信息

Clin Cancer Res. 2012 Mar 15;18(6):1751-9. doi: 10.1158/1078-0432.CCR-11-2442. Epub 2012 Jan 24.

DOI:10.1158/1078-0432.CCR-11-2442

PMID:22275504

Abstract

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.

摘要

目的

细胞因子诱导的杀伤（CIK）细胞在肾细胞癌（RCC）中的治疗益处尚不清楚。本前瞻性随机研究旨在评估自体 CIK 细胞免疫疗法在转移性透明细胞 RCC 患者中的疗效。

实验设计

2005 年 6 月至 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（arm 1，n = 74）或白细胞介素-2 联合 IFN-α-2a 治疗组（arm 2，n = 74）。主要终点为总生存期（OS），次要终点为无进展生存期（PFS），通过 Kaplan-Meier 分析和 Cox 比例风险模型评估治疗 HRs。

结果

arm 1 的 3 年 PFS 和 OS 分别为 18%和 61%，而 arm 2 分别为 12%和 23%（P = 0.031 和 <0.001）。arm 1 的中位 PFS 和 OS 明显长于 arm 2（PFS，12 个月 vs. 8 个月，P = 0.024；OS，46 个月 vs. 19 个月，P < 0.001）。多变量分析表明，CIK 细胞免疫治疗的周期数作为连续变量与延长的 PFS[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）显著相关。