Autologous cytokine-induced killer cell immunotherapy in lung cancer: a phase II clinical study

Autologous cytokine-induced killer cell immunotherapy in lung cancer: a phase II clinical study
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DOI:
10.1007/s00262-012-1260-2
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发表时间:
2012-11-01
影响因子:
5.8
通讯作者:
Li, Hui
Li, Hui
中科院分区:
医学3区
文献类型:
--
作者:
Li, Runmei;Wang, Changli;Li, Hui

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目的细胞因子诱导的杀伤(CIK)细胞在体内外均具有杀伤肿瘤的能力。为探讨CIK细胞免疫治疗对非小细胞肺癌(NSCLC)患者术后常规化疗的临床疗效,对87例Ⅰ ~ Ⅳ期NSCLC患者进行配对研究。患者接受化疗(组2)或化疗联合自体CIK细胞免疫治疗(组1)。结果87例患者中,50例为早期(I-IIIA期),37例为晚期(IIIB-IV期)。在早期患者中,两组3年PFS率和中位PFS时间的分布无统计学差异(分别为p = 0.259和0.093);然而,第1组的3年OS率和中位OS时间显著高于第2组(分别为82%与66%; p = 0.049和73%与53个月; p = 0.006)。在晚期患者中,组1的3年PFS和OS率显著高于组2(分别为6 vs. 3%; p < 0.001和31 vs. 3%; p < 0.001);组1的中位PFS和OS时间也显著长于组2(分别为13与6个月; p = 0.001和24与10个月; p < 0.001)。多因素分析表明,CIK细胞免疫治疗的频率与PFS延长显著相关(HR = 0.91; 95% CI 0.85-0.98; p = 0.012)和OS(HR = 0.83; 95% CI,0.74-0.93; P = 0.001)。结论CIK细胞免疫治疗可提高NSCLC患者常规化疗的疗效,增加CIK细胞治疗频率可进一步增强有益效果。我们医院正在进行一项多中心随机试验,以进一步验证这些发现。
Objective Cytokine-induced killer (CIK) cells have the ability to kill tumor in vitro and in vivo. This study was designed to evaluate the clinical efficacy of CIK cell immunotherapy following regular chemotherapy in patients with non-small cell lung cancer (NSCLC) after surgery.Methods A paired study, with 87 stage I-IV NSCLC patients in each group, was performed. Patients received either chemotherapy (arm 2) or chemotherapy in combination with autologous CIK cell immunotherapy (arm 1). Progression-free survival (PFS) and overall survival (OS) were evaluated.Results Of the 87 paired patients, 50 had early-stage disease (stage I-IIIA) and 37 had advanced-stage disease (stage IIIB-IV). Among early-stage patients, the distribution of 3-year PFS rate and median PFS time showed no statistical difference between the two groups (p = 0.259 and 0.093, respectively); however, the 3-year OS rate and median OS time in arm 1 were significantly higher than those in arm 2 (82 vs. 66 %; p = 0.049 and 73 vs. 53 months; p = 0.006, respectively). Among the advanced-stage patients, the 3-year PFS and OS rates of arm 1 were significantly higher than those of arm 2 (6 vs. 3 %; p < 0.001 and 31 vs. 3 %; p < 0.001, respectively); the median PFS and OS times in arm 1 were also significantly longer than those in arm 2 (13 vs. 6 months; p = 0.001 and 24 vs. 10 months; p < 0.001, respectively). Multivariate analyses indicated that the frequency of CIK cell immunotherapy was significantly associated with prolonged PFS (HR = 0.91; 95 % CI 0.85-0.98; p = 0.012) and OS (HR = 0.83; 95 % CI, 0.74-0.93; p = 0.001) in the arm 1.Conclusions The data suggested that CIK cell immunotherapy could improve the efficacy of conventional chemotherapy in NSCLC patients, and increased frequency of CIK cell treatment could further enhance the beneficial effects. A multi-center randomized trial is being carried out in our hospital to further validate these findings.