Individualization of Systemic Therapy in Patients with Estrogen Receptor-Pos

雌激素受体阳性患者全身治疗的个体化

• 批准号: 9142050
• 负责人: ALLISON W. KURIAN
• 金额: $ 27.63万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2018-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9142050
• 关键词: Address; Adjuvant Chemotherapy; Affect; Aftercare; Attitude; Biological Assay; Breast; Breast Cancer Treatment; Caring; Characteristics; Client satisfaction; Clinical; Cohort Studies; Communication; Data; Data Set; Data Sources; Decision Making; Diagnosis; Diffusion; Disease; Distant; Estrogen Receptors; Estrogen receptor positive; Family; Foundations; Friends; Genes; Genomics; Instruction; Intervention; Knowledge; Lead; Malignant Neoplasms; Medical Oncologist; Medical Surveillance; New Jersey; Oncologist; Patient Rights; Patient Selection; Patients; Play; Policies; Process; Recurrence; Registries; Regrets; Reporting; Research; Research Personnel; Risk; Risk Estimate; Role; Sampling; Staging; Surveys; Systemic Therapy; Testing; Woman; breast cancer diagnosis; cancer recurrence; chemotherapy; genomic profiles; health literacy; hormone therapy; improved; individualized medicine; innovation; malignant breast neoplasm; mathematical ability; outcome forecast; personalized care; population based; prospective; response; satisfaction; treatment effect; tumor

Decision-making regarding breast cancer adjuvant chemotherapy in patients with favorable prognoses poses challenges for clinicians and patients alike given the relatively low marginal benefit of chemotherapy. Genomic profile assays in early stage, estrogen receptor-positive breast cancer refine estimates of both the risk of distant recurrence and the marginal benefit of chemotherapy over endocrine therapy alone and thereby enhance individualized care for patients with cancer. The benefits of the assay, however, will be realized only if the assay is used in the right patients and if receipt of chemotherapy is guided by assay results. The extent to which genomic profiling assays are used in practice and the impact of the assay results on receipt of chemotherapy in population-based patient samples are unknown. The aims of this study are to investigate patient and clinician factors associated with the use of genomic profiles, specifically the 21-gene assay, and the impact of the assay on receipt of chemotherapy in at population-based sample. In addition, the study findings will inform innovative dissemination strategies of our research findings among oncologists. To achieve these aims, we will conduct a prospective population-based cohort study of 3,200 patients with early stage invasive, estrogen receptor-positive breast cancer and their treating oncologists (approximately 270) in the state-wide New Jersey and Georgia Surveillance, Epidemiology, and End Results (SEER) registries. Patients who are candidates for the genomic assay and their oncologists will be surveyed several months after diagnosis. Patient-reported variables, oncologist knowledge and attitudes elicited through vignettes, practice characteristics obtained from the oncologist survey, and SEER data will be merged to create a unique dataset. Multilevel analyses will incorporate consideration of patient, clinician, and practice influences on use of the assay and receipt of chemotherapy. The project aims will address critical barriers to our understanding of use and diffusion of tests-not only in breast cancer-^that promote individualized care and will ultimately help guide policies and interventions aimed at improving care.

乳腺癌患者辅助化疗的决策 由于相对较低的边际效益， 化疗基因组分析在早期阶段，雌激素受体阳性乳腺癌细化估计的风险，远处复发和边际效益的化疗内分泌治疗，从而提高癌症患者的个性化护理。然而，只有在正确的患者中使用该检测试剂盒，并且根据检测结果指导接受化疗，才能实现该检测试剂盒的益处。目前尚不清楚基因组谱分析在实践中的应用程度以及分析结果对基于人群的患者样本接受化疗的影响。本研究的目的是调查与使用基因组相关的患者和临床医生因素 在基于人群的样本中，分析了基因谱，特别是21-基因测定，以及测定对接受化疗的影响。此外，研究结果将告知我们的研究结果在肿瘤学家之间的创新传播策略。为了实现这些目标，我们将在全州范围内的新泽西和格鲁吉亚监测、流行病学和最终结果（SEER）登记研究中，对3,200例早期浸润性雌激素受体阳性乳腺癌患者及其治疗肿瘤学家（约270名）进行一项前瞻性基于人群的队列研究。候选患者 在诊断后几个月，将对基因组测定及其肿瘤学家进行调查。患者报告的变量，肿瘤学家的知识和态度，从肿瘤学家调查中获得的实践特征，以及SEER数据将被合并，以创建一个独特的数据集。多水平分析将考虑患者、临床医生和实践对检测试剂盒使用和接受化疗的影响。该项目的目标是解决我们理解使用和传播的关键障碍 不仅是乳腺癌检测，它还能促进个体化护理，并最终帮助指导旨在改善护理的政策和干预措施。