Advanced Anatomic and Functional Response Assessment in Lung Cancer

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），采用一维（RECIST）或二维（WHO）标准测量肿瘤大小。同样的标准也用于衡量肺癌患者的研究性治疗的有效性。在过去的30年里，尽管出现了新的治疗方法和成像技术的进步，这种方法几乎没有改变。我们和其他人已经发现，仅在一个或两个维度上确定肿瘤大小的变化并不能充分捕获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（如吉非替尼或厄洛替尼）或血管生成抑制剂（如贝伐单抗）治疗的肿瘤中的放射学变化不一定以与用标准细胞毒性疗法治疗的那些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、中央坏死和密度变化，而这些变化可能无法通过最大病变直径的传统测量来捕捉。也会发生只能在PET FDG或FIT成像上捕获的功能变化。本研究的目的是通过使用先进的成像技术将肿瘤缓解与生物标志物以及无疾病进展和生存期相关联，研究使用成像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）的患者组的早期缓解和进展。具体而言，1.在接受细胞毒性、EGFR-TKI和抗血管生成治疗的患者中，使用RECIST、二维、CT体积测量以及FDG-PET代谢变化和FLT-PET增殖变化评估分类缓解评估，并将这些缓解测量得出的最佳总体缓解和无进展生存期与总体生存期相关联。2.比较总血浆DNA结果与基于图像的缓解（最佳总缓解和无进展生存期）和总生存期。3.确定使用连续量表最佳总体缓解是否比目前使用的分类缓解评估更好地预测。

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.