Advanced Anatomic and Functional Response Assessment in Lung Cancer

肺癌的高级解剖和功能反应评估

• 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
• 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

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）：评估患者对化学疗法反应的标准方法是使用计算机断层扫描（CT）使用单差（RECIST）或BI二维（WHO）标准来测量肿瘤大小。使用相同的标准来评估研究疗法在肺癌患者中的有效性。尽管出现了新的疗法和成像技术的进步，但在过去30年中，这种方法的变化很少。我们和其他人发现，仅确定一个或二维中肿瘤大小的变化不会充分捕获新疗法对原发性肿瘤和转移的影响。用表皮生长因子受体受体激酶抑制剂（例如吉非替尼或厄洛替尼）或血管生成抑制剂（例如贝伐单抗）（例如贝伐单抗）治疗的肿瘤的射线照相变化，不一定像在那些用标准细胞毒素治疗的个体中观察到的相同的幅度或速度发生。借助这些较新的药物，肿瘤通过经历囊性变化，中央坏死和密度变化做出反应，这些变化可能不会通过最大病变直径的常规测量来捕获。还会发生仅在PET FDG或FIT成像上捕获的功能变化。这项研究的目的是研究使用成像来评估接受不同类型的全身疗法（标准细胞毒性，EGFR-TKI和抗血管生成标准）对肺癌的早期反应和进展，通过使用先进的成像技术与生物标志物以及无生物标志物以及无疾病的进展和生存的肿瘤反应相关联。具体而言，1。使用恢复，双维，体积测量的CT以及对FDG-PET的代谢变化以及对FLT-PET的代谢变化的变化，对细胞毒性，EGFR-TKI和抗基安基因疗法的抗反应和抗抗反应的自由生存量的生存率相关联，对这些响应的整体生存量来评估fDG-PET和FLT-PET的增殖的分类响应评估。 2。将总等离子体DNA结果与基于图像的响应（最佳总体反应和无进展生存）和总生存期进行比较。 3。确定使用连续规模是否比当前使用的分类响应评估更好地预测总体响应。