Laboratory of Tumor Immunology & Biology, Center for Cancer Research, National Cancer Institute, 10 Center Drive, 8B09 MSC 1750, Bethesda, MD 20892, USA.
Immunotherapy. 2011 Jan;3(1):27-31. doi: 10.2217/imt.10.77.
For many years, preclinical and clinical studies have attempted to harness the power of the immune system and focus it on malignant cells in an attempt to improve clinical outcomes for patients with cancer. This paper describes the landmark Phase III trial that led to the first US FDA approval of a therapeutic cancer vaccine. In a randomized trial of 512 patients, those treated with sipuleucel-T survived for 25.8 months compared with those treated with placebo, who survived 21.7 months (HR: 0.78; p = 0.03). There was, however, no change in time to progression, which may relate to the underlying mechanism of this new class of therapeutics.
多年来,临床前和临床研究一直试图利用免疫系统的力量,将其集中在恶性细胞上,以改善癌症患者的临床结果。本文描述了一项具有里程碑意义的 III 期临床试验,该试验导致了首个美国 FDA 批准的治疗性癌症疫苗。在一项 512 名患者的随机试验中,接受 sipuleucel-T 治疗的患者存活时间为 25.8 个月,而接受安慰剂治疗的患者存活时间为 21.7 个月(HR:0.78;p = 0.03)。然而,无进展时间没有变化,这可能与这一新类治疗药物的潜在机制有关。