Dendreon Corporation, Research, Seattle, WA, USA.
Hum Vaccin Immunother. 2012 Apr;8(4):520-7. doi: 10.4161/hv.18769. Epub 2012 Feb 28.
Sipuleucel-T, the first autologous active cellular immunotherapy approved by the United States Food and Drug Administration, is designed to stimulate an immune response to prostate cancer. Sipuleucel-T is manufactured by culturing a patient's peripheral blood mononuclear cells (including antigen presenting cells) with a recombinant protein comprising a tumor-associated antigen (prostatic acid phosphatase) and granulocyte-macrophage colony stimulating factor. Treatment consists of 3 infusions at approximately 2-week intervals, resulting in a prime-boost pattern of immune activation, a robust antigen-specific cellular and humoral immune response, and, consequently, a survival benefit in subjects with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. Adverse events are generally mild to moderate and resolve within 2 d. Serious adverse events occur at a low rate. As the first autologous cellular immunotherapy to demonstrate a survival benefit, sipuleucel-T is a novel oncologic therapeutic that warrants the reassessment of the current prostate cancer treatment paradigm.
Sipuleucel-T 是美国食品和药物管理局批准的首个自体主动细胞免疫疗法，旨在刺激对前列腺癌的免疫反应。Sipuleucel-T 通过培养患者的外周血单个核细胞（包括抗原呈递细胞）与包含肿瘤相关抗原（前列腺酸性磷酸酶）和粒细胞-巨噬细胞集落刺激因子的重组蛋白来制造。治疗包括 3 次输注，大约间隔 2 周，形成免疫激活的初始-增强模式，产生强大的抗原特异性细胞和体液免疫反应，从而使无症状或轻度症状的转移性去势抵抗性前列腺癌患者获益。不良事件通常为轻度至中度，在 2 天内得到解决。严重不良事件的发生率较低。作为首个证明生存获益的自体细胞免疫疗法，Sipuleucel-T 是一种新型肿瘤治疗药物，值得重新评估当前的前列腺癌治疗模式。
