National Utilization Patterns of Oncotype DX in Early Stage Breast Cancer

Oncotype DX 在早期乳腺癌中的全国使用模式

• 批准号: 8519160
• 负责人: Michaela Ann Dinan
• 金额: $ 13.52万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-08-01 至 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8519160
• 关键词: National; Utilization; Patterns; Oncotype; DX

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.

描述（由申请人提供）：OncotypeDX 21-基因复发评分测定（ODX）是用于指导早期雌激素受体阳性（ER+）、淋巴结阴性乳腺癌患者管理的最广泛使用的基因签名。在临床试验和小患者人群的背景下使用ODX表明，在受控环境中，ODX可能会改变大约25-33%患者的管理决策，并可能减少化疗的使用和相关费用，毒性和对生活质量的阻碍，一家私人保险公司估计每位患者可节省1，200美元。更新的2007年ASCO指南建议，ODX测试可用于患者，以确定患者预后和化疗的相对效益。 有一个关键的需要，以了解哪些患者在一般美国癌症人口实际上 接受ODX检测以及它如何影响他们的治疗，结果和成本，因为在对照临床试验或建模环境之外没有进行流行病学研究。在这项提案中，我们调查了OncotypeDX（ODX）基因组检测在全国代表性老年乳腺癌患者人群中的使用。 目标1：表征全国范围内ODX在早期乳腺癌中的使用情况 目的2：研究与ODX利用相关的差异化疗利用 目标3：调查与ODX使用相关的不同医疗保健成本 将分子医学纳入全科医学依赖于许多在临床试验环境中未解决的因素，包括获得新兴技术，指南依从性和护理质量的变化，成本，患者人口统计学，区域差异以及其他未观察到的患者和医生因素，这些因素可能会显着影响护理。拟议的研究解决了理解诸如Oncotype DX基因组测试等分子技术如何在实际实践中使用的重大需求，并详细介绍了一种创新的概念方法，该方法使用新的索赔方法和医患共享网络建模，结合传统的严格方法来检查全国范围内的临床重要问题，以优化乳腺癌患者的当前临床实践。