CIK细胞用于中晚期非小细胞肺癌一线维持治疗的临床观察

目的 探讨自体细胞因子诱导的杀伤（CIK）细胞免疫治疗在中晚期非小细胞肺癌（NSCLC）一线维持治疗中的疗效及安全性。方法 选取本院2009年6月至2011年3月接受一线治疗且疗效评价稳定（SD）或以上的NSCLC患者112例，随机分为治疗组（n=56）和对照组（n=56）。在接受一线化疗方案原药或减药的维持化疗基础上，治疗组加用CIK细胞免疫治疗，检测CIK细胞治疗前后外周血T细胞亚群的变化；根据药物毒副反应判定标准NCI-CTC 4.0，观察两组患者的毒副反应情况并随访远期生存。结果 CIK治疗后较治疗前T细胞亚群状态改善，未见3～4级不良反应。治疗组的中位无进展生存期（PFS）为8.6个月，高于对照组的7.5个月（P＜0.05），中位生存时间（OS）分别为19.2个月和18.6个月，差异无统计学意义（P＞0.05）；治疗组中一线疗效≥50％PR-CR者（靶病灶最大径之和缩小50％～100％）的中位PFS为11.5个月，高于疗效＜50％PR-SD者（靶病灶最大径之和缩小0～50％）的79个月（P＜005），但中位OS的差异无统计学意义（P＞0.05）；对照组中一线疗效≥50％PR-CR者和疗效＜50％PR-SD者中位PFS及OS的差异均无统计学意义（P＞0.05）；一线疗效≥50％PR-CR者中，治疗组的中位PFS为11.5个月，亦高于对照组的88个月（P＜0.05），但中位OS的差异无统计学意义（P＞0.05）。结论 CIK细胞免疫治疗在中晚期NSCLC维持治疗中，可以改善患者免疫功能，提高自身抗肿瘤能力，延长PFS，而且具有良好的安全性，可提高NSCLC维持治疗的疗效。

Clinical observation of maintenance therapy with autologous cytokine-induced killer cells in patients with medium and advanced non-small cell lung cancer after first-line treatment

Objective To investigate the efficacy and safety of maintenance therapy with autologous cytokine induced killer cells（CIK） in patients with medium and advanced non-small cell lung cancer（NSCLC） after first line treatment. MethodsA total of 112 medium and advanced NSCLC patients with therapeutic effect of SD or above after first line treatment were selected and assigned to treatment group（n=56） and control group（n=56） at random. The treatment group accepted maintenance therapy with autologous CIK cells after the first line treatment. T lymphocyte subpopulations in peripheral blood were measured and the side effects were estimated according to NCI-CTC 4.0 version. Then， patients of both groups were followed up. Results The statuses of T lymphocyte subpopulation were improved after the therapy with autologous CIK cells and no side effects of grade 3-4 occurred. The median progression free survival（PFS） of treatment group was 8.6 months， higher than 7.5 months of control group（P＜0.05）. The median overall survival（OS） in treatment group and control group were 19.2 and 18.6 months without significant difference（P＞0.05）. In treatment group， the median PFS in patients with therapeutic effect ≥50％ PR-CR was 11.5 months， higher than 7.9 months in patients with ＜50％ PR-SD and the difference was significant（P＜0.05）， but no difference was observed on the median OS between both subgroups（P＞005）. In control group, there was no significant difference on the median PFS and OS between patients with therapeutic effect ≥50％ PR-CR or ＜50％ PR-SD（P＞0.05）. In the cases whose therapeutic effect ≥50％ PR-CR， the median PFS was 11.5 months in treatment group， higher than 8.8 months in control group with significant difference（P＜0.05）， but no difference was observed on the median OS between both groups（P＞0.05）. Conclusion Maintenance therapy with autologous CIK cells in patients with medium and advanced NSCLC after first line treatment improves the immune function and enhances the ability of anti tumor effect by natural immunity with a prolonged PFS and well tolerated toxicity.