首页 > 肿瘤医学词汇大全 > Sipuleucel-T
A Randomized Phase II Trial of Sipuleucel-T with Concurrent versus Sequential Abiraterone Acetate plus Prednisone in Metastatic Castration-Resistant Prostate Cancer.
一项 Sipuleucel-T 同期与序贯醋酸阿比特龙联合泼尼松治疗转移性去势抵抗性前列腺癌的随机 II 期试验。

摘要

PURPOSE:This phase II open-label study evaluated the effect of concurrent or sequential administration of abiraterone acetate plus prednisone (AA + P) on sipuleucel-T manufacture and immune responses in metastatic castration-resistant prostate cancer (mCRPC) patients.
EXPERIMENTAL DESIGN:mCRPC patients received sipuleucel-T followed by AA + P 1 day (concurrent) or 10 weeks (sequential) after the first sipuleucel-T infusion. AA + P treatment continued for 26 weeks. The primary endpoint was cumulative antigen presenting cell (APC) activation, and secondary endpoints included cumulative APC number and total nucleated cell counts. Additional endpoints included in vivo peripheral immune responses to sipuleucel-T (T-cell responses, T-cell proliferation, humoral responses, and antigen spread) as well as safety.
RESULTS:Sixty-nine mCRPC patients were enrolled, with 35 and 34 patients randomized to the concurrent and sequential arms, respectively. Ex vivo APC activation was significantly greater at the second and third infusions compared with baseline in both arms (P < 0.05), indicative of an immunologic prime-boost effect. In both arms, sipuleucel-T product parameter profiles and peripheral immune responses were consistent with previously conducted sipuleucel-T phase III trials. Antigen spread was similarly observed in both arms and consistent with the other immunologic endpoints.
CONCLUSIONS:These data suggest that sipuleucel-T can be successfully manufactured during concurrent administration of AA + P without blunting immunologic effects or altering immune parameters that correlate with sipuleucel-T's clinical benefit. Combination of these agents was well tolerated, with no new safety signals emerging.

译文

目的: 这项 II 期开放标签研究评估了同时或连续服用醋酸阿比特龙加泼尼松 (AA P) 的效果关于转移性去势抵抗性前列腺癌 (mCRPC) 患者的 sipuleucel-T 制造和免疫反应。
实验设计: mCRPC 患者接受 sipuleucel-T,然后在第一次 sipuleucel-T 输注后 1 天 (同时) 或 10 周 (连续) 进行 AA P。AA P 治疗持续 26 周。主要终点是累积抗原呈递细胞 (APC) 激活,次要终点包括累积 APC 数量和总有核细胞计数。其他终点包括对 sipuleucel-T 的体内外周免疫反应 (T 细胞反应、 T 细胞增殖、体液反应和抗原扩散) 以及安全性。
结果: 69 例 mCRPC 患者被纳入研究,其中 35 例和 34 例患者分别随机分配到并行组和序贯组。与双臂基线相比,第二次和第三次输注时的体外 APC 活化显著增加 (P & lt; 0.05),表明免疫素增强效应。在两组中,sipuleucel-T 产品参数分布和外周免疫反应与先前进行的 sipuleucel-T III 期试验一致。在双臂中同样观察到抗原扩散,并与其他免疫终点一致。
结论: 这些数据表明,在 AA P 的同时给药过程中,sipuleucel-T 可以成功制造,而不会减弱免疫效应或改变与 sipuleucel-T 的临床益处相关的免疫参数。这些药物的组合耐受性良好,没有新的安全信号出现。

Sipuleucel-T

肿瘤 前列腺癌 治疗方法
概述  :  

Sipuleucel-T是Valeant Pharmaceuticals公司研发,2010年4月获得美国FDA批准的用于治疗无症状或症状轻微的转移性去势治疗无效的难治性前列腺癌(CRPC)。它是迄今为止首个被FDA批准的治疗性癌症疫苗。Sipuleucel-T 是一种自体细胞来源的免疫治疗药,它由自体树突状细胞(DCs)与融合蛋白 PA2024在体外共孵化获得,其中 PA2024 是一种由前列腺酸性磷酸酶(PAP)和粒细胞巨噬细胞集落刺激因子 (GM-CSF) 构建的融合蛋白(PAP-GM-

Sipuleucel 

释    义   n. 西普鲁塞

例    句   Sipuleucel-T's main drawback is that each treatment has to be handcrafted to the individual receiving it, using dendritic cells from his own body. 西普鲁塞-T的主要缺点是,每一种治疗都必须是手工制作的,使用的是来自患者自身的树突细胞。

请扫描右侧二维码,免费查看词汇专业知识背景