目的：评价细胞因子诱导的杀伤细胞（cytokineinduced killer cell，CIK）免疫治疗在肾细胞癌治疗中的效果。方法：收集天津医科大学附属肿瘤医院2000年1月至2010年7月接受CIK治疗的119例肾细胞癌患者作为治疗组，IL2联合IFN治疗的119例肾细胞癌患者作为对照组。119对患者确诊时临床分期为：Ⅰ期21对，Ⅱ期21对，Ⅲ期49对，Ⅳ期28对。配对因素包括临床分期、性别、年龄、中性粒细胞计数、血小板、血红蛋白、乳酸脱氢酶、β2微球蛋白、KPS评分等，两组配对因素均衡一致。随访时间为2001年1月至2011年4月，临床疗效的观察终点为无进展生存（progressionfree survival，PFS）和总生存（overall survival，OS）。结果：治疗组与对照组5年PFS率分别为44%、42%（P=0.056），5年OS率分别为72%、51%（P<001）。两组患者中位PFS时间分别为54和43个月（P=0.088），中位OS时间分别为134和60个月（P<0.01）。两组中Ⅰ+Ⅱ期患者的PFS、OS差异无统计学意义；Ⅲ+Ⅳ期患者中，治疗组5年PFS、OS率明显高于对照组（26% vs 18%，P<0.01；58% vs 31%，P<0.01），且中位PFS、OS时间明显长于对照组（36个月 vs 13个月，P<001；68个月 vs 33个月，P<0.01）。多因素分析显示，CIK治疗的疗程数与患者PFS（HR=0.95，95% CI: 0.92~0.99，P<0.05）和OS（HR=0.79，95% CI: 0.71~0.87，P<0.001）相关，最佳CIK治疗的疗程数为7次以上。结论：CIK免疫疗程可以显著改善Ⅲ、Ⅳ期肾细胞癌患者预后，增加CIK治疗疗程数可以提高疗效。

Objective:To evaluate the efficacy of cytokineinduced killer cells（CIK）in treatment of patients with renal cell carcinoma. Methods: All the patients were diagnosed as renal cell carcinoma in Affiliated Cancer Hospital of Tianjin Medical University from January 2000 to July 2010. One hundred and nineteen patients received CIK treatment (CIK group) and 119 patients received treatment of IL2 in combination with IFN (control group). Of the 119 paired patients, 21 pairs had stage Ⅰ disease, 21 pairs stage Ⅱ, 49 stage Ⅲ, and 28 stage Ⅳ. Pairing consideration include clinical stage,sex,age,neutrophil count, platelet count,hemoglobin level,lactate dehydrogenase activity,β2microglobulin level and Karnofsky performance status at the time of diagnosis. Progressionfree survival (PFS) and overall survival (OS) were evaluated. Results:The 5year PFS and OS rates in the CIK and control groups were 44% and 42% (P=0.056), and 72% and 51% (P<0.001), respectively. The median PFS and OS in the CIK and control groups were 54 and 43 months (P=0.088), and 134 and 60 months (P<0.001), respectively. Patients with stage Ⅰ+Ⅱ disease in these two groups showed no statistical difference in PFS and OS. However, the 5year PFS and OS of stage Ⅲ+Ⅳ patients in the CIK group were significantly higher than those in the control group (26% vs 18%, P<0.001, and 58% vs 31%, P<0.001; respectively), the median PFS and OS of stage Ⅲ+Ⅳ patients in the CIK group were also remarkably longer than those in the control group (36 months vs 13 months, P=0.005; and 68 months vs 33 months, P<0.001; respectively). In the multivariate analysis, the frequency of CIK immunotherapy was related to the PFS (HR=0.95, 95% CI: 0.92-0.99, P=0.013) and OS (HR=0.79, 95% CI: 0.71-0.87, P<0.001). The optimal outpoint of the frequency was seven times. Conclusion: CIK immunotherapy can improve the prognosis of stage Ⅲ and Ⅳ renal cell carcinoma patients and increasing the frequency of CIK treatment benefits patients more.

天津市科技创新专项资金资助项目（No. 06FZZDSF01500）；天津市应用基础及前沿技术研究计划资助项目（No. 09JCZDJC20400）