National Utilization Patterns of Oncotype DX in Early Stage Breast Cancer

描述(申请人提供)：OncotypeDX 21基因复发评分分析(ODX)是最广泛用于指导早期、雌激素受体阳性(ER+)、淋巴结阴性乳腺癌患者治疗的基因标记。在临床试验和患者人数较少的情况下使用ODX表明，在受控设置下，ODX可能会改变大约25%-33%的患者的管理决定，并可能减少化疗的使用以及相关成本、毒性和生活质量障碍，一家私营保险公司估计每个患者可节省1200美元。2007年更新的ASCO指南建议，可以在患者中使用ODX检测来确定患者的预后和化疗的相对益处。 迫切需要了解美国普通癌症人群中到底有哪些患者 接受ODX测试以及它如何影响他们的治疗、结果和成本，因为尚未在受控临床试验或模拟环境之外进行过关于其使用的流行病学研究。在这项提案中，我们调查了OncotypeDX(ODX)基因组检测在全国具有代表性的老年乳腺癌患者群体中的应用。 目的1：了解全国范围内ODX在早期乳腺癌中的使用情况 目的2：研究不同化疗方案与ODX利用率的关系 目标3：调查与ODX使用相关的不同医疗保健成本 将分子医学应用于全科医学依赖于许多在临床试验设置中没有解决的因素，包括获得新兴技术、指南遵守情况和护理质量的变化、成本、患者人口统计、地区差异以及其他可能对护理产生重大影响的未观察到的患者和医生因素。这项拟议的研究解决了了解诸如Oncotype DX基因组测试等分子技术如何在实际应用中使用的重要需要，并详细说明了一种创新的概念性方法，使用新的索赔方法和医生-患者共享网络建模，结合传统的严格方法，在全国范围内检查临床重要问题，以便优化目前乳腺癌患者的临床实践。

DESCRIPTION (provided by applicant): The OncotypeDX 21-gene recurrence score assay (ODX) is the most widely used gene signature for guiding the management of patients with early stage, estrogen receptor positive (ER+), lymph node negative breast cancers. The use of ODX within the context of clinical trials and small patient populations indicates that in controlled settings, ODX likely changes management decisions in roughly 25-33% of patients and may reduce the use of chemotherapy and associated costs,toxicities, and impediments to quality of life, with one private insurer estimating savings of $1,200 per patient. Updated 2007 ASCO guidelines recommend that ODX testing may be used in patients to determine both patient prognosis and the relative benefit of chemotherapy. There is a critical need to understand which patients in the general U.S. cancer population actually receive ODX testing and how it affects their treatment, outcomes, and costs, as no epidemiologic studies of its use have been conducted outside of controlled clinical trial or modeling settings. In this proposal, we investigate the use of OncotypeDX (ODX) genomic testing in a nationally representative elderly breast cancer patient population. Aim 1: Characterize Nationwide Utilization of ODX in early stage breast cancer Aim 2: Investigate differential chemotherapy utilization associated with ODX utilization Aim 3: Investigate differential health care costs associated with ODX utilization The adoption of molecular medicine into general practice relies on many factors that are not addressed within the setting of clinical trials that include access to emerging technologies, variation in guideline adherence and quality of care, costs, patient demographics, regional variation, and other unobserved patient and physician factors that may significantly impact care. The proposed research addresses the significant need to understand how molecular technologies such as the Oncotype DX genomic test are being used in actual practice and details an innovative conceptual approach using novel claims methods and physician-patient sharing network modeling in combination with conventional rigorous methodologies to examine clinically important questions on a national scale in order to optimize current clinical practice fr breast cancer patients.