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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。
Objective To investigate the efficacy and safety of autologous cytokine-induced cytotoxicity (CIK) cell immunotherapy in first-line maintenance of advanced non-small cell lung cancer (NSCLC). Methods One hundred and twelve patients with NSCLC who received first-line therapy and had stable therapeutic effect (SD) or more in our hospital from June 2009 to March 2011 were randomly divided into treatment group (n = 56) and control group (n = 56). In the first-line chemotherapy regimens on the basis of chemotherapy or anti-chemotherapy, the treatment group plus CIK cell immunotherapy to detect changes in peripheral blood T cell subsets in CIK cells before and after treatment; according to drug toxicity criteria NCI-CTC 4.0 , Observe the two groups of patients with side effects and follow-up long-term survival. Results After CIK treatment, the status of T cell subsets was improved before treatment, and no grade 3 to 4 adverse reactions were found. The median progression-free survival (PFS) in the treatment group was 8.6 months, which was significantly higher than that in the control group (P <0.05), and the median survival time (OS) was 19.2 months and 18.6 months, respectively (P> 0.05). The median PFS of first-line response ≥50% of PR-CR patients (50% -100% reduction of target lesion maximum diameter) in the treatment group was 11.5 months, which was higher than that of <50% (P <0.05), but there was no significant difference between the two groups (P> 0.05). The first-line efficacy of the control group was ≥50 There was no significant difference in median PFS and OS between patients with PR% and those with PR% -PR% or less than 50% PR-SD (P> 0.05). The median PFS 11.5 months, also higher than the control group of 8.8 months (P <0.05), but the median OS was no significant difference (P> 0.05). Conclusion CIK cell immunotherapy can improve immune function, improve self-anti-tumor ability and prolong PFS in the maintenance of advanced NSCLC. And it has good safety and can improve the curative effect of maintenance treatment of NSCLC.