Advanced Anatomic and Functional Response Assessment in Lung Cancer

肺癌的高级解剖和功能反应评估

基本信息

批准号：
7876979
负责人：
Lawrence H Schwartz
金额：
$ 30.75万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-08-07 至 2012-06-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7876979
关键词：
Algorithms Alternative Therapies Anatomy Angiogenesis Inhibitors Biological Markers Caliber Clinical Data DNA Development Dimensions Disease Effectiveness Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Erlotinib Gefitinib Goals High Resolution Computed Tomography Image Imaging Techniques Imaging technology Individual Investigational Therapies Lesion Malignant neoplasm of lung Manuals Measurement Measures Metabolism Methodology Methods Necrosis Neoplasm Metastasis New Agents Outcome Patients Pharmaceutical Preparations Plasma Positron-Emission Tomography Primary Neoplasm Progression-Free Survivals Public Domains Qualifying Research Resistance Signal Transduction Speed Systemic Therapy Techniques Testing X-Ray Computed Tomography base bevacizumab chemotherapy clinically significant cytotoxic density novel outcome forecast response tumor

项目摘要

DESCRIPTION (provided by applicant): The standard way to assess a patient's response to chemotherapy is to use computed tomography (CT) to measure tumor size using uni-dimensional (RECIST) or bi-dimensional (WHO) criteria. The same standards are used to gauge the effectiveness of investigational therapies in patients with lung cancer. This methodology has changed little in the past 30 years despite the emergence of new therapies and advances in imaging technology. We and others have found that only determining the changes in the size of tumors in one or two dimensions does not adequately capture the effects of novel therapies on primary tumors and metastases. Radiographic changes in tumors treated with epidermal growth factor receptor tyrosine kinase inhibitors such as gefitinib or erlotinib or inhibitors of angiogenesis such as bevacizumab do not necessarily occur at the same magnitude or speed as observed in those individuals treated with standard cytotoxic therapies. With these newer agents, tumors respond by undergoing cystic change, central necrosis and density changes that may not be captured by conventional measurements of the largest lesion diameter. Functional changes that can only be captured on PET FDG or FIT imaging also occur. The goals of this study are to investigate the use of imaging to assess early response and progression in groups of patients receiving different types of systemic therapy (standard cytotoxic, EGFR-TKI and antiangiogenic standard) for lung cancer by correlating tumor response using advanced imaging techniques with biomarkers as well as with disease-free progression and survival. Specifically, 1.To evaluate categorical response assessment using RECIST, bi-dimensional, volumetric measures on CT and changes in metabolism on FDG-PET and proliferation on FLT-PET in patients on cytotoxic, EGFR-TKI and antiangiogenic therapy and to correlate the Best Overall Response and Progression Free Survival derived from these measurements of response with overall survival. 2. To compare total plasma DNA results with image based response (best overall response and progression free survival) and overall survival. 3. To determine if the use of a continuous scale best overall response better predicts than the categorical response assessment currently used.

描述（由申请人提供）：评估患者对化疗反应的标准方法是使用计算机断层扫描（CT），按照一维（RECIST）或二维（WHO）标准测量肿瘤大小。相同的标准用于衡量肺癌患者研究疗法的有效性。尽管出现了新疗法和成像技术的进步，但这种方法在过去 30 年中几乎没有变化。我们和其他人发现，仅确定一维或二维肿瘤大小的变化并不能充分捕捉新疗法对原发性肿瘤和转移瘤的影响。用表皮生长因子受体酪氨酸激酶抑制剂（例如吉非替尼或厄洛替尼）或血管生成抑制剂（例如贝伐珠单抗）治疗的肿瘤的放射线变化不一定以与用标准细胞毒性疗法治疗的个体中观察到的相同的幅度或速度发生。使用这些较新的药物，肿瘤会发生囊性变化、中心坏死和密度变化，而这些变化可能无法通过最大病变直径的常规测量来捕获。只能通过 PET FDG 或 FIT 成像才能捕获的功能变化也会发生。本研究的目的是通过使用先进的成像技术关联肿瘤反应，研究如何使用影像学来评估接受不同类型肺癌全身治疗（标准细胞毒性、EGFR-TKI 和抗血管生成标准）的患者组的早期反应和进展具有生物标志物以及无病进展和生存。具体来说， 1. 使用 RECIST、CT 上的二维体积测量以及 FDG-PET 上的代谢变化和 FLT-PET 上的增殖变化来评估接受细胞毒性、EGFR-TKI 和抗血管生成治疗的患者的分类反应评估，并将最佳值关联起来。总体反应和无进展生存期源自这些反应与总体生存期的测量。 2. 将总血浆 DNA 结果与基于图像的反应（最佳总体反应和无进展生存期）和总体生存期进行比较。 3. 确定使用连续量表最佳总体响应是否比当前使用的分类响应评估能更好地进行预测。