Department of Internal Medicine, Faculty of Medical Sciences, State University of Campinas, Campinas, Brazil.
J Exp Clin Cancer Res. 2011 Jun 17;30(1):65. doi: 10.1186/1756-9966-30-65.
Overall therapeutic outcomes of advanced non-small-cell lung cancer (NSCLC) are poor. The dendritic cell (DC) immunotherapy has been developed as a new strategy for the treatment of lung cancer. The purpose of this study was to evaluate the feasibility, safety and immunologic responses in use in mature, antigen-pulsed autologous DC vaccine in NSCLC patients.
Five HLA-A2 patients with inoperable stage III or IV NSCLC were selected to receive two doses of 5 × 107 DC cells administered subcutaneous and intravenously two times at two week intervals. The immunologic response, safety and tolerability to the vaccine were evaluated by the lymphoproliferation assay and clinical and laboratorial evolution, respectively.
The dose of the vaccine has shown to be safe and well tolerated. The lymphoproliferation assay showed an improvement in the specific immune response after the immunization, with a significant response after the second dose (p = 0.005). This response was not long lasting and a tendency to reduction two weeks after the second dose of the vaccine was observed. Two patients had a survival almost twice greater than the expected average and were the only ones that expressed HER-2 and CEA together.
Despite the small sample size, the results on the immune response, safety and tolerability, combined with the results of other studies, are encouraging to the conduction of a large clinical trial with multiples doses in patients with early lung cancer who underwent surgical treatment.
Current Controlled Trials: ISRCTN45563569.
晚期非小细胞肺癌（NSCLC）的整体治疗效果较差。树突状细胞（DC）免疫疗法已被开发为治疗肺癌的新策略。本研究旨在评估成熟的、抗原脉冲自体 DC 疫苗在 NSCLC 患者中的应用的可行性、安全性和免疫反应。
选择 5 名 HLA-A2 期不可切除的 III 或 IV 期 NSCLC 患者，接受两次剂量为 5×107 个 DC 细胞，每两周皮下和静脉注射两次。通过淋巴细胞增殖试验、临床和实验室演变分别评估疫苗的免疫反应、安全性和耐受性。
疫苗剂量显示安全且耐受良好。淋巴细胞增殖试验显示免疫后特异性免疫反应有所改善，第二次剂量后有显著反应（p=0.005）。这种反应不是持久的，并且在第二次疫苗剂量后两周观察到有减少的趋势。两名患者的生存时间几乎是预期平均值的两倍，并且是唯一同时表达 HER-2 和 CEA 的患者。
尽管样本量较小，但免疫反应、安全性和耐受性的结果，结合其他研究的结果，令人鼓舞，可以在接受手术治疗的早期肺癌患者中进行多次剂量的大型临床试验。
当前对照试验：ISRCTN45563569。
