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A Randomized Phase II Trial of Adjuvant Galinpepimut-S, WT-1 Analogue Peptide Vaccine, After Multimodality Therapy for Patients with Malignant Pleural Mesothelioma.
恶性胸膜间皮瘤患者综合治疗后,辅助 Galinpepimut-S (WT-1 类似物肽疫苗) 的随机 II 期试验。

摘要

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.Conclusions: The favorable safety profile was confirmed. PFS and OS were greater in those who received vaccine, but the trial was neither designed nor powered for comparison between the arms. On the basis of these promising results, the investigators are planning a larger randomized trial with greater statistical power to define the optimal use and benefit of galinpepimut-S in the treatment of MPM. Clin Cancer Res; 23(24); 7483-9. ©2017 AACR.

译文

目的: 确定恶性胸膜间皮瘤 (MPM) 患者的 1 年无进展生存率 (PFS) 多模式治疗后接受 WT1 肽疫苗 galinpepimut-S 与接受对照组佐剂的比较。实验设计: 这个双盲的,受控的,两个中心 II 期试验术后随机 MPM 患者和另一种治疗方式为 galinpepimut-S 与 GM-CSF 和 Montanide 或 GM-CSF 和 Montanide 单独使用。1 年 PFS 从 50% 提高到 70% 是预定义的疗效阈值,并且计划总共 78 名患者。这项研究没有动力用于两组之间的比较。结果: 41 名患者是随机的。治疗相关的不良事件是轻微的,自我限制的,并且没有临床意义。在严格的预先指定的无效分析 (无效 = ≥ 10 的 20 名患者在一只手臂上经历进展 <1 年) 的基础上,控制臂提前关闭。治疗臂随后被关闭,因为结果是不致盲。在对照组和疫苗组中,研究治疗开始后 1 年的 PFS 率分别为 33% 和 45%。在控制组和疫苗组中,中位 PFS 分别为 7.4 个月和 10.1 个月,中位 OS 分别为 18.3 个月和 22.8 个月。结论: 良好的安全性得到了证实。接受疫苗的人的 PFS 和 OS 更大,但是该试验既不是为武器之间的比较而设计的,也不是为动力。在这些有希望的结果的基础上,研究人员正在计划一项更大的具有更大统计能力的随机试验,以确定 galinpepimut-S 在 MPM 治疗中的最佳用途和益处。Clin Cancer Res; 23 (24); 7483-9。©2017 AACR。

Galinpepimut-S

肿瘤 疫苗 治疗方法
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

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。

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