Project 2

项目2

• 批准号: 10491111
• 负责人: Felicity Harper
• 金额: $ 36.79万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 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/10491111
• 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; Clinical Trials; Consolidation Therapy; County; DNA Sequence Alteration; Demographic Factors; Disease; Documentation; Dose; Emergency Situation; Enrollment; Goals; Histology; Hospitalization; Immune; Immune checkpoint inhibitor; Immunotherapy; Individual; Institutes; Intervention; Knowledge; Malignant Neoplasms; Malignant neoplasm of lung; Measures; Moods; Non-Small-Cell Lung Carcinoma; Nonmetastatic; Outcome; Pathway interactions; Patients; Platinum; Population; Quality of life; Race; Reporting; Research; Risk; Risk Factors; Sampling; Self Efficacy; Smoking History; Socioeconomic Status; Symptoms; Testing; Time; Treatment Side Effects; Unresectable; Visit; base; cancer diagnosis; cancer health disparity; cancer therapy; chemotherapy; comorbidity; cost; health disparity; 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

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.

项目摘要 肺癌治疗中最重要的进步之一是引入免疫 检查点抑制剂（ICIS），无论是单个药物还是与铂基化学疗法结合使用） 现在是大多数转移性非小细胞肺癌（NSCLC）患者的前线治疗。治疗时 响应率可能是显着的，副作用，尤其是与免疫相关的不良事件（IRAE），是主要的 忧虑。如果不受控制，副作用可能会导致不定期的护理，自付费用增加 患者以及治疗延迟或中断。非裔美国人在 肺癌的诊断比白人诊断，非裔美国人和白人之间存在已知差异 尊重癌症治疗的许多方面，包括启动时间和化学疗法的剂量，症状 负担，甚至对副作用的治疗。但是，关于种族的潜在差异知之甚少 尊重对ICI治疗的反应很大程度上是由于缺乏非裔美国人患者临床 试验导致FDA批准。因此，迫切需要探索非裔美国人和白人是否 患者受到与ICI治疗有关的副作用的差异影响。具体目的是：1） 表征患者报告的副作用和生活质量以及与ICI相关的临床医生评估的IRAE 在标准护理环境中接受治疗的一组非裔美国人和白肺癌患者的治疗； 2）确定患者报告的一面的社会人口统计学，个体和疾病的决定因素 与ICI治疗相关的生活质量和质量和伊拉斯的质量以及划分的差异。尽管 ICIS有望改善结果，对患者报告的潜在预测因素知之甚少 副作用和生活质量和伊拉斯因种族而异。这项研究将直接评估多层预测指标 对非裔美国人和白人患者的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 朝着更具股权的使用方式迈入ICIS的使用。通过确定潜在差异的驱动因素， 我们可以更好地识别患有副作用和伊拉斯的高风险的患者，制定干预措施以减少危险因素， 从而提高患者的生活质量并减少结果的种族差异。