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: 8702135
• 负责人: Michaela Ann Dinan
• 金额: $ 13.58万
• 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/8702135
• 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基因复发评分测定法（ODX）是使用最广泛使用的基因签名，用于指导早期阶段，雌激素受体阳性（ER+），淋巴结阴性乳腺癌患者的管理。在临床试验和少数患者人群的背景下，使用ODX的使用表明，在受控的环境中，ODX可能会改变大约25-33％的患者的管理决策，并可能减少使用化学疗法和相关成本，毒性，毒性以及对生活质量的障碍的使用，其中一名私人保险公司估计每位患者的储蓄为1,200美元。更新的2007年ASCO指南建议可以在患者中使用ODX测试来确定患者预后和化学疗法的相对好处。 迫切需要了解美国一般癌症人群中哪些患者 接受ODX测试及其如何影响其治疗，结果和成本，因为在对照临床试验或建模环境之外，没有对其使用的流行病学研究进行。在此提案中，我们研究了在全国代表性的乳腺癌患者人群中使用Oncotypedx（ODX）基因组测试。 AIM 1：在早期乳腺癌中全国范围内ODX的使用表征 目标2：研究与ODX利用相关的差异化疗利用 目标3：调查与ODX利用相关的差异医疗保健费用 将分子医学的采用用于普通实践取决于在临床试验中未解决的许多因素，包括访问新兴技术，指南依从性和护理质量的差异，成本，患者人口统计学，区域变异以及其他未经关注的患者和医生因素可能会对护理产生重大影响。拟议的研究旨在了解如何在实际实践中使用分子技术，例如Oncotype DX基因组检验，并详细介绍一种创新的概念方法，使用新颖的索赔方法和医师患者分享网络建模，结合常规的严格方法与常规的严格方法结合使用，以在当前的临床规模上检查临床上重要的问题，以使当前的临床疗法在当前的临床诊所临床诊所临床临床诊所患者中进行最佳范围。