Clinical Research Division, Fred Hutchinson Cancer Research Center, and Division of Medical Oncology, University of Washington, Seattle, WA 98109, USA.
Clin Cancer Res. 2011 Jun 1;17(11):3520-6. doi: 10.1158/1078-0432.CCR-10-3126. Epub 2011 Apr 6.
Sipuleucel-T (PROVENGE; Dendreon) is the first therapeutic cancer vaccine to be approved by the U.S. Food and Drug Administration. In men who have metastatic castration-resistant prostate cancer with no or minimal symptoms, sipuleucel-T prolongs median survival by 4.1 months compared with results in those treated with placebo. At 3 years, the proportion of patients in the vaccine group who were alive was 50% higher than that in the control group (31.7% versus 21.7%, respectively). Sipuleucel-T, which is designed to elicit an immune response to prostatic acid phosphatase, uses the patient's own immune system to recognize and combat his cancer. Currently, no other agents are available that offer a survival benefit for this population of asymptomatic patients who have not been treated with chemotherapy, except for docetaxel (whose inherent toxicities often lead patients and physicians to delay administration until symptoms develop). Straightforward strategies to increase the efficacy of sipuleucel-T are likely to provide even greater benefit. The preclinical and clinical development of sipuleucel-T is reviewed, and approaches to enhance efficacy are considered herein.
Sipuleucel-T（普罗文奇；Dendreon）是首个获得美国食品和药物管理局批准的治疗性癌症疫苗。在转移性去势抵抗性前列腺癌且无症状或症状轻微的男性中，与安慰剂治疗相比，sipuleucel-T 可使中位生存期延长 4.1 个月。3 年时，疫苗组的患者存活率比对照组高 50%（分别为 50%和 31.7%）。Sipuleucel-T 旨在诱导针对前列腺酸性磷酸酶的免疫反应，利用患者自身的免疫系统来识别和对抗癌症。目前，除多西他赛（由于其固有的毒性，常导致患者和医生在症状出现后才开始使用，从而延迟了治疗）外，对于未接受化疗的无症状患者，尚无其他可提供生存获益的药物。增加 sipuleucel-T 疗效的简单策略可能会带来更大的获益。本文回顾了 sipuleucel-T 的临床前和临床开发，并探讨了增强其疗效的方法。
