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Galinpepimut-S

肿瘤

关键词肿瘤 治疗方法 疫苗

词汇介绍

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解析

Galinpepimut-S

释    义   n. Galinpepimut-S疫苗

例    句   A prior pilot study to assess the safety, activity, and immunogenicity of galinpepimut-S included nine patients with MPM and 3 with NSCLC. 先前评估galinpepimut-S安全性、活性和免疫原性的试点研究包括9例MPM患者和3例NSCLC患者。

概述

新型Galinpepimut-S疫苗,简写为GPS,GPS是一种靶向WT1(Wilms Tumor 1)蛋白的癌症疫苗,由4条多肽链构成,抗原表位多达25个,能够激发自身免疫系统对WT1抗原强烈的免疫反应,它与其他疗法相结合可以达到杀伤缓解期时体内残存的肿瘤细胞和加强免疫系统对肿瘤细胞的免疫监察作用。WT1是最广泛表达的癌症抗原之一,已被美国国家癌症研究所(NCI)列为癌症免疫治疗的首要靶标。重要的是,由于WT1抗原在多种血液恶性肿瘤和实体肿瘤细胞中过表达,但在大多数正常组织中没有发现,因此

A Randomized Phase II Trial of Adjuvant Galinpepimut-S, WT-1 Analog Peptide Vaccine, after Multimodality Therapy for Patients with Malignant Pleural Mesothelioma复制标题

恶性胸膜间皮瘤患者综合治疗后辅助Galinpepimut-S,WT-1类似肽疫苗的随机II期试验

发表时间:2017-12-15

影响因子:8.9

作者: Marjorie G. Zauderer

期刊:Clin. Cancer Res.

Purpose: Determine the 1-year progression-free survival (PFS) rate among patients with malignant pleural mesothelioma (MPM) receiving the WT1 peptide vaccine galinpepimut-S after multimodality therapy versus those receiving control adjuvants. Experimental Design: This double-blind, controlled, two center phase II trial randomized MPM patients after surgery and another treatment modality to galinpepimut-S with GM-CSF and Montanide or GM-CSF and Montanide alone. An improvement in 1-year PFS from 50% to 70% was the predefined efficacy threshold, and 78 patients total were planned. The study was not powered for comparison between the two arms. Results: Forty-one patients were randomized. Treatment-related adverse events were mild, self-limited, and not clinically significant. On the basis of a stringent prespecified futility analysis (futility = ≥10 of 20 patients on one arm experiencing progression < 1 year), the control arm closed early. The treatment arm was subsequently closed because of the resultant unblinding. The PFS rate at 1 year from beginning study treatment was 33% and 45% in the control and vaccine arms, respectively. Median PFS was 7.4 months versus 10.1 months and median OS was 18.3 months versus 22.8 months in the control and vaccine arms, respectively.

译文

目的:确定接受多模式治疗后接受WT1肽疫苗galinpepimut-S的恶性胸膜间皮瘤(MPM)患者与接受对照佐剂的患者的1年无进展生存率(PFS)。实验设计:这项双盲,对照,两个中心II期临床试验对MPM患者进行了手术后随机分组,另一种针对galinpepimut-S的GM-CSF和Montanide或GM-CSF和Montanide单独治疗。 1年PFS从50%提高到70%是预定义的疗效阈值,计划共78例患者。该研究无权进行两个部门之间的比较。结果:41例患者被随机分组。与治疗有关的不良事件是轻度的,自我限制的,在临床上不显着。根据严格的预先设定的无效性分析(无效性=≥20名患者的一只手臂的进展<1年的患者中≥10),对照臂应尽早关闭。随后,由于产生的致盲现象,治疗臂被关闭。从开始研究治疗开始的第1年,对照组和疫苗组的PFS率分别为33%和45%。对照组和疫苗组的中位PFS分别为7.4个月和10.1个月和中位OS为18.3个月和22.8个月。