Sipuleucel-T
Sipuleucel-T
复制标题
DOI：
10.1038/nrd3220
复制
发表时间：
2010-07-01
影响因子：
120.1
通讯作者：
Kantoff, Philip W.
中科院分区：
文献类型：
--
作者：
Higano, Celestia S.;Small, Eric J.;Kantoff, Philip W.
目前，无症状或症状轻微的转移性去势抵抗性前列腺癌（CRPC）患者的治疗选择很少。二线激素治疗的中位有效期为3个月，但从未显示出延长生存期。直到最近，多西他赛是FDA批准的唯一一种mCRPC治疗方法，已被证明可延长生存期。Sipuleucel-T是一种自体细胞免疫疗法。在最初的3期研究中，未证实对疾病进展时间的主要终点的显著影响，但观察到与对照组相比，中位生存期延长了4.5个月。随后在512例无症状或症状轻微的CRPC患者中进行的sipuleucel-T III期研究，与对照组相比，中位生存期延长了4.1个月。在随机试验中sipuleucel-T治疗的患者中观察到的最常见的不良事件是寒战、疲劳、发热、背痛、恶心、关节痛和头痛。与sipuleucel-T疗法相关的生存益处、不良事件特征和短疗程（4周）使其成为无症状转移性去势抵抗性前列腺癌患者的有吸引力的治疗选择。
Few treatment options are currently available for patients with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (CRPC). Second line hormonal approaches are effective for a median of 3 months’ time but have never been shown to prolong survival. Until recently, docetaxel was the only FDA-approved therapy for mCRPC that has been shown to extend survival. Sipuleucel-T is an autologous cellular immunotherapy treatment. In an initial Phase 3 study, a significant effect on the primary endpoint of time to disease progression was not demonstrated, but a 4.5-month improvement in median survival compared to control was observed. A subsequent phase III study of sipuleucel-T in 512 men with asymptomatic or minimally symptomatic CRPC, resulted in a 4.1-month improvement in median survival compared to control. The most common adverse events observed in sipuleucel-T treated patients in randomized trials have been chills, fatigue, fever, back pain, nausea, joint ache, and headache. The survival benefit, adverse event profile, and short course of treatment (4 weeks) associated with sipuleucel-T therapy make it an appealing treatment option for asymptomatic metastatic castrate resistant prostate cancer patients.