Project 2

项目2

基本信息

批准号：
10684281
负责人：
Felicity Harper
金额：
$ 28.99万
依托单位：
WAYNE STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-20 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10684281
关键词：
Adherence African American African American population Age Area Automobile Driving Behavioral Biological Markers Cancer Patient Caring Characteristics Chemotherapy and/or radiation Cities Clinical Trials Consolidation Therapy County DNA Sequence Alteration Demographic Factors Disease Disparity Documentation Dose Emergency Situation Enrollment Equity Goals Histology Hospitalization Immune Immune checkpoint inhibitor Immunotherapy Individual Intervention Knowledge Malignant Neoplasms Malignant neoplasm of lung Measures Moods Non-Small-Cell Lung Carcinoma Outcome Pathway interactions Patients Platinum Population Quality of life Race Reporting Research Risk Risk Factors Risk Reduction Sampling Self Efficacy Smoking History Socioeconomic Status Symptoms Testing Time Treatment Side Effects Unresectable Visit cancer diagnosis cancer health disparity cancer therapy chemotherapy clinical trial enrollment comorbidity cost high risk immune-related adverse events improved improved outcome metropolitan outcome prediction racial difference racial disparity racial diversity response sex side effect sociodemographics standard care standard of care treatment effect treatment response treatment trial tumor urgent care

项目摘要

Project Summary One of the most significant advancements in lung cancer treatment has been the introduction of immune checkpoint inhibitors (ICIs), which either as single agents or in combination with platinum-based chemotherapy, are now front-line therapy for most patients with metastatic non-small cell lung cancer (NSCLC). While treatment response rates can be remarkable, side effects, especially immune-related adverse events (irAEs), are of major concern. When uncontrolled, side effects can result in unscheduled care, increased out-of-pocket costs for patients, and treatment delays or discontinuation. African Americans continue to have worse outcomes after a lung cancer diagnosis than whites, and there are known differences between African Americans and whites with respect to many aspects of cancer treatment, including time to initiation and dose of chemotherapy, symptom burden, and even treatment of side effects. However, little is known about potential differences by race with respect to response to ICI treatment largely due to a lack of inclusion of African American patients in the clinical trials leading to FDA approvals. Thus, there is a critical need to explore whether African American and white patients are differentially impacted by side effects related to ICI treatment. The specific aims are to: 1) Characterize patient-reported side effects and quality of life and clinician-assessed irAEs associated with ICI treatment in a group of African American and white lung cancer patients being treated in a standard care setting; and 2) Identify the sociodemographic, individual, and disease-specific determinants of patient-reported side effects and quality of life and irAEs associated with ICI treatment and characterize differences by race. While ICIs holds promise for improved outcomes, little is known about whether potential predictors of patient-reported side effects and quality of life and irAEs vary by race. This study will directly evaluate multi-level predictors in response to ICI treatment in African American and white patients. Understanding the sociodemographic, individual, and disease-specific determinants of these outcomes in lung cancer patients provides the basis for moving towards a more equity-focused approach to the use of ICIs. By identifying drivers of potential disparities, we can better identify patients at high risk for side effects and irAEs, develop interventions to reduce risk factors, thereby improving patient quality of life and reducing racial disparities in outcomes.

项目概要肺癌治疗最显着的进步之一是免疫疗法的引入检查点抑制剂（ICIs），可以作为单一药物或与铂类化疗联合使用，现在是大多数转移性非小细胞肺癌（NSCLC）患者的一线治疗。治疗时缓解率可能非常显着，但副作用，尤其是免疫相关不良事件 (irAE) 是主要的忧虑。如果不加以控制，副作用可能会导致计划外的护理，增加自付费用患者以及治疗延迟或停止。非裔美国人在经历了肺癌诊断率高于白人，非裔美国人和白人之间存在已知的差异关于癌症治疗的许多方面，包括开始化疗的时间和剂量、症状负担，甚至副作用的治疗。然而，人们对不同种族之间的潜在差异知之甚少。对 ICI 治疗的反应主要是由于临床中缺乏非裔美国患者的参与导致 FDA 批准的试验。因此，迫切需要探讨非洲裔美国人和白人是否患者受到 ICI 治疗相关副作用的影响不同。具体目标是：1）描述患者报告的副作用和生活质量以及临床医生评估的与 ICI 相关的 irAE 一组在标准护理环境中接受治疗的非裔美国人和白人肺癌患者的治疗； 2) 确定患者报告一侧的社会人口统计学、个体和疾病特异性决定因素与 ICI 治疗相关的影响和生活质量以及 irAE，并描述了种族差异的特征。尽管 ICI 有望改善结果，但对于患者报告的潜在预测因素知之甚少副作用、生活质量和 irAE 因种族而异。本研究将直接评估多级预测变量非裔美国人和白人患者对 ICI 治疗的反应。了解社会人口统计学，肺癌患者这些结果的个体和疾病特异性决定因素为转向更加注重公平的 ICI 使用方法。通过识别潜在差异的驱动因素，我们可以更好地识别副作用和 irAE 高风险患者，制定干预措施以减少风险因素，从而提高患者的生活质量并减少结果的种族差异。