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树突状细胞(dendritic cell,DC)免疫治疗作为一种无严重毒性反应、前景广阔的主动免疫治疗策略,自从1998年以来,已经在转移性肾细胞癌(metastatic renal cell carcinoma,mRCC)的治疗中进行了广泛研究,并在2007年5月韩国FDA批准了一种称为CreaVax RCC的自体DC疫苗用于mRCC的治疗。目前已经有31项非随机对照的Ⅰ/Ⅱ期临床试验研究了DC免疫治疗用于mRCC患者的安全性和有效性,虽然这些试验结果已经证实DC免疫治疗的安全性和对一小部分mRCC患者的有效性,但这些临床试验在受试者选择、DC疫苗的标准化、免疫学终点和临床终点的选择和评价等方面难以统一标准,这导致DC免疫治疗疗效的发挥受限且不同试验结果无法进行直接比较;另外,所开展的试验均为非随机对照小样本临床研究。因此,期待临床试验设计方案的进一步优化,以客观评估DC免疫治疗对mRCC患者的临床治疗效果,并应在临床试验中加强对DC免疫治疗联合mRCC一线治疗方案疗效的评价,以进一步开发对mRCC更加有效的联合治疗策略。
Dendritic cell (DC) immunotherapy As a promising active immunotherapy strategy with no serious toxicity, it has been used in the treatment of metastatic renal cell carcinoma (mRCC) since 1998 In May 2007, the South Korean FDA approved a self-generated DC vaccine called CreaVax RCC for the treatment of mRCC. Thirty-one non-randomized Phase I / II clinical trials have investigated the safety and efficacy of DC immunotherapy in patients with mRCC although these trials have demonstrated the safety and efficacy of DC immunotherapy in a minority of patients with mRCC However, these clinical trials are difficult to unify in the selection of subjects, standardization of DC vaccines, choice of immunological end point and clinical end point, and evaluation, which results in the limited efficacy of DC immunotherapy and different test results Direct comparison; In addition, the tests carried out are non-randomized controlled small sample clinical study. Therefore, looking forward to further optimization of clinical trial design to objectively assess the clinical efficacy of DC immunotherapy in patients with mRCC, and should strengthen the evaluation of the efficacy of DC immunotherapy combined with first-line treatment of mRCC in clinical trials to further develop the mRCC More effective combination treatment strategy.