Carolina Urologic Research Center/Atlantic Urology Clinics, Myrtle Beach, SC 29572, USA.
Cancer Control. 2013 Jan;20(1):7-16. doi: 10.1177/107327481302000103.
Sipuleucel-T is an autologous cellular immunotherapy approved by the US Food and Drug Administration for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer. Its mechanism of action is based on stimulation of the patient's own immune system to target prostate cancer. Peripheral blood mononuclear cells, including antigen-presenting cells and T cells, are obtained from patients via leukapheresis and treated ex vivo with PA2024, a fusion protein consisting of prostatic acid phosphatase/granulocyte-macrophage colony-stimulating factor antigen.
Data relating to the potential pharmacodynamic biomarkers associated with sipuleucel-T activity are reviewed, as well as considerations for patient selection and for sequencing sipuleucel-T with other prostate cancer treatments. Possible directions for future development are also discussed, including treatment of less advanced prostate cancer populations, combination treatment, and immune modulation.
Data from three randomized, double-blind, placebo-controlled phase III clinical trials of sipuleucel-T in patients with metastatic castration-rresistant prostate cancer have shown improvement in overall survival vs control. Here, we review its developing role in prostate cancer therapy and future directions for development.
There is potential to build on sipuleucel-T to further advance immunotherapy of prostate cancer.
Sipuleucel-T 是一种获得美国食品和药物管理局批准的自体细胞免疫疗法，用于治疗无症状或轻度症状的转移性去势抵抗性前列腺癌。其作用机制基于刺激患者自身免疫系统靶向前列腺癌。通过白细胞分离术从患者中获得外周血单核细胞，包括抗原呈递细胞和 T 细胞，并在体外使用 PA2024 进行处理，PA2024 是一种由前列腺酸性磷酸酶/粒细胞-巨噬细胞集落刺激因子抗原组成的融合蛋白。
回顾与 sipuleucel-T 活性相关的潜在药效学生物标志物数据，以及患者选择和与其他前列腺癌治疗联合应用 sipuleucel-T 的考虑因素。还讨论了未来发展的可能方向，包括治疗进展程度较低的前列腺癌患者、联合治疗和免疫调节。
三项随机、双盲、安慰剂对照的 III 期临床试验的数据表明，与安慰剂相比，转移性去势抵抗性前列腺癌患者接受 sipuleucel-T 治疗可改善总体生存率。在这里，我们回顾了它在前列腺癌治疗中的发展作用和未来的发展方向。
有可能在 sipuleucel-T 的基础上进一步推进前列腺癌的免疫治疗。
