【佳学基因检测】2 型神经纤维瘤病相关前庭神经鞘瘤 II 期抗肿瘤药物研究的建议反应标准

1年靶向药物要多少钱评价

探索明白《J Neurooncol》在 2009 May;93(1):61-77发表了一篇题目为《2 型神经纤维瘤病相关前庭神经鞘瘤 II 期抗肿瘤药物研究的建议反应标准》肿瘤靶向药物治疗基因检测临床研究文章。该研究由Scott R Plotkin, Chris Halpin, Jaishri O Blakeley, William H Slattery rd, D Bradley Welling, Susan M Chang, Jay S Loeffler, Gordon J Harris, A Gregory Sorensen, Michael J McKenna, Fred G Barker nd等完成。促进了肿瘤的精准治疗与个性化用药的发展，进一步强调了基因信息检测与分析的重要性。

肿瘤靶向药物及精准治疗临床研究内容关键词：

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肿瘤靶向治疗基因检测临床应用结果

2型神经纤维瘤病（NF2）是一种以多发性神经鞘瘤，尤其是前庭神经鞘瘤（VS）和脑膜瘤为特征的抑癌基因综合征。目前正在探索抗癌药物试验，但 NF2 没有标准化的终点。我们回顾了 NF2 临床试验的挑战，并提出了用于初始 II 期研究的可能反应标准。我们建议在此类试验中使用两个主要的反应标准。客观放射学反应定义为 VS 体积持久减少 20% 或更多，基于通过内耳道收集 3 毫米或更细切口的增强后 T1 加权 MRI 图像。听力反应被定义为在听力学中使用 50 个单词的记录列表在单词识别分数方面的统计显着改善。概述了结合放射学反应和听力反应的可能复合终点。我们强调应对评估中的陷阱，并提出指导方针，以尽量减少对应对的误解。我们还确定了 NF2 的研究目标，以促进未来的试验进行，例如确定对未经治疗的 NF2 相关 VS 的肿瘤进展时间和可测量听力损失时间的预期，以及这两个终点与患者预后因素（如年龄）的关系、基线肿瘤体积和疾病严重程度的测量）。这些数据将有助于未来使用基于肿瘤大小和听力稳定性的端点，这可能更适合测试某些药物。我们鼓励在为该人群开发 II 期试验的早期采用标准化终点，以促进不同药物试验之间结果的比较。

肿瘤发生与复发转移国际数据库描述：

Neurofibromatosis type 2 (NF2) is a tumor suppressor gene syndrome characterized by multiple schwannomas, especially vestibular schwannomas (VS), and meningiomas. Anticancer drug trials are now being explored, but there are no standardized endpoints in NF2. We review the challenges of NF2 clinical trials and suggest possible response criteria for use in initial phase II studies. We suggest two main response criteria in such trials. Objective radiographic response is defined as a durable 20% or greater reduction in VS volume based on post-contrast T1-weighted MRI images collected with 3 mm or finer cuts through the internal auditory canal. Hearing response is defined as a statistically significant improvement in word recognition scores using 50-word recorded lists in audiology. A possible composite endpoint incorporating both radiographic response and hearing response is outlined. We emphasize pitfalls in response assessment and suggest guidelines to minimize misinterpretations of response. We also identify research goals in NF2 to facilitate future trial conduct, such as identifying the expectations for time to tumor progression and time to measurable hearing loss in untreated NF2-related VS, and the relation of both endpoints to patient prognostic factors (such as age, baseline tumor volume, and measures of disease severity). These data would facilitate future use of endpoints based on stability of tumor size and hearing, which might be more appropriate for testing certain drugs. We encourage adoption of standardized endpoints early in the development of phase II trials for this population to facilitate comparison of results across trials of different agents.

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