Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, U.S.A.
Curr Oncol. 2011 Jun;18(3):e150-7. doi: 10.3747/co.v18i3.783.
With the recent approval by the U.S. Food and Drug Administration of the first therapeutic vaccine for cancer, the long-awaited goal of harnessing a patient's immune system to attack cancer through this modality is finally realized. However, as researchers in the field of cancer immunotherapy continue to perform randomized definitive studies, much remains to be learned about potential surrogate endpoints and appropriate patient populations for therapeutic vaccines. The present review addresses available data from clinical trials of immunotherapeutic agents relevant to the selection of appropriate patient populations. We believe that the weight of evidence supports the use of immunotherapy earlier in the disease course and in patients with less aggressive disease, and that the relevant findings have important implications for the design of clinical trials with therapeutic vaccines.
随着美国食品和药物管理局最近批准了第一种癌症治疗性疫苗，通过这种方式利用患者的免疫系统来攻击癌症的长期目标终于实现了。然而，随着癌症免疫治疗领域的研究人员继续进行随机对照的研究，对于治疗性疫苗的潜在替代终点和合适的患者人群仍有许多需要了解。本综述讨论了与选择合适的患者人群相关的免疫治疗药物临床试验的现有数据。我们认为，证据的权重支持在疾病早期和疾病较轻的患者中更早地使用免疫疗法，相关发现对治疗性疫苗临床试验的设计具有重要意义。
