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Sipuleucel-T

肿瘤

关键词肿瘤 治疗方法 前列腺癌

词汇介绍

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解析

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。

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-

Real-World Outcomes of Sipuleucel-T Treatment in PROCEED, a Prospective Registry of Men With Metastatic Castration-Resistant Prostate Cancer复制标题

Sipuleucel-T治疗的真实世界结果,一个转移性去势抵抗性前列腺癌男性的前瞻性登记

发表时间:2019-09-04

影响因子:6.1

作者: Celestia S. Higano

期刊:Cancer

In 2011-2017, 1976 patients were followed for 46.6 months (median). The median age was 72 years, and the baseline median prostate-specific antigen level was 15.0 ng/mL; 86.7% were white, and 11.6% were African American. Among the patients, 1902 had 1 or more sipuleucel-T infusions. The median OS was 30.7 months (95% confidence interval [CI], 28.6-32.2 months). Known prognostic factors were independently associated with OS in a multivariable analysis. Among the 1255 patients who died, 964 (76.8%) died of prostate cancer (PC) progression. The median time from the first infusion to PC death was 42.7 months (95% CI, 39.4-46.2 months). The incidence of sipuleucel-T-related SAEs was 3.9%. The incidence of CVEs was 2.8%, and the rate per 100 person-years was 1.2 (95% CI, 0.9-1.6). The CVE incidence among 11,972 patients with mCRPC from the Surveillance, Epidemiology, and End Results-Medicare database was 2.8%; the rate per 100 person-years was 1.5 (95% CI, 1.4-1.7). One or more ACIs (abiraterone, enzalutamide, docetaxel, cabazitaxel, or radium 223) were received by 77.1% of the patients after sipuleucel-T; 32.5% and 17.4% of the patients experienced 1- and 2-year treatment-free intervals, respectively.

译文

在2011-2017年,对1976名患者进行了46.6个月的随访(中位)。中位年龄为72岁,基线中位前列腺特异性抗原水平为15.0 ng / mL;白人占86.7%,非裔美国人占11.6%。在这些患者中,1902年进行了1次或更多次sipuleucel-T输注。中位OS为30.7个月(95%置信区间[CI]为28.6-32.2个月)。在多变量分析中,已知的预后因素与OS独立相关。在1255名死亡的患者中,有964名(76.8%)因前列腺癌(PC)进展而死亡。从第一次输注到PC死亡的中位时间为42.7个月(95%CI,39.4-46.2个月)。 sipuleucel-T相关SAE的发生率为3.9%。 CVE的发生率为2.8%,每100人年的发生率为1.2(95%CI,0.9-1.6)。根据监测,流行病学和最终结果-医疗保险数据库,在11,972例mCRPC患者中,CVE发生率为2.8%。每100人年的比率为1.5(95%CI,1.4-1.7)。 sipuleucel-T术后77.1%的患者接受一种或多种ACI(阿比特龙,恩杂鲁胺,多西紫杉醇,卡巴他赛或镭223);分别有32.5%和17.4%的患者经历了1年和2年的无治疗间隔。