Primary Prevention to Reduce Cardiovascular Morbidity and Optimize Cancer Outcomes

降低心血管发病率和优化癌症结果的一级预防

基本信息

批准号：
10522430
负责人：
Aniket A Kawatkar
金额：
$ 71.84万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-08-10 至 2027-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10522430
关键词：
Address Adult American American Heart Association American Society of Clinical Oncology Anthracycline Antihypertensive Agents Atherosclerosis Biochemistry Breast Cancer Patient Cancer Patient Cancer Survivor Cardiology Cardiotoxicity Cardiovascular Diseases Cardiovascular system Chemotherapy-Oncologic Procedure Computerized Medical Record Data Data Set Decision Making Disease Disease Outcome Dose Early Diagnosis Early treatment Economic Burden Evaluation Event Expenditure Financial Support Functional disorder Future Goals Guidelines Health Health Policy Healthcare Heterogeneity Histopathology Incidence Income Individual Informatics Infrastructure Interdisciplinary Study Lead Long-Term Effects Longterm Follow-up Malignant Neoplasms Medical Medical Oncologist Metastatic to Methods Modeling Monitor Morbidity - disease rate Morphology Myocardial dysfunction Observational Study Oncologist Oncology Outcome Outcome Study Patient-Focused Outcomes Patients Pharmaceutical Preparations Pharmacology Policies Policy Making Prevention Prevention Guidelines Prevention therapy Primary Prevention Progression-Free Survivals Radiation Oncologist Recommendation Recurrence Regimen Research Resources Retrospective cohort Risk Societies Subgroup System Techniques Treatment outcome Treatment-Related Cancer United States Social Security Administration base cancer recurrence cancer therapy cardiovascular disorder risk chemotherapy clinical practice cohort college comparative effectiveness compare effectiveness cost cost effective cost effectiveness disability economic outcome evidence base experience financial toxicity health care service organization healthy lifestyle high risk hypertensive improved innovation malignant breast neoplasm mortality multimodality neoplasm registry patient subsets prevent programs relative effectiveness risk stratification targeted treatment treatment choice treatment effect treatment response tumor

项目摘要

Project Summary Our overarching goal is to identify and characterize cancer patients at risk of developing cancer treatment- related cardiotoxicity and to mitigate cardiovascular dysfunction while optimizing cancer outcomes. Advances in early detection and treatment of cancer has improved 5-year survival. However, multi-modal cancer treatment often leads to cardiotoxicity. Cardiovascular disease (CVD) events during treatment can interfere with its delivery and thus lead to sub-optimal cancer outcomes and increased downstream morbidity, cost, and mortality. American Heart Association (2019) guidelines recommend primary prevention with anti- hyperlipidemic and anti-hypertensive medication in high-risk individuals, based on atherosclerotic cardiovascular disease (ASCVD) risk. However, it’s uncertain if primary prevention in cancer patients improves long-term CVD outcomes. American Society of Clinical Oncology (ASCO) (2017) guidelines has categorized high-dose anthracyclines, targeted therapy, and certain combinations of these, as cardiotoxic regimens. The impact of primary prevention in patients on such cardiotoxic regimens is unknown. To evaluate these questions, we will create a unique dataset by merging Kaiser Permanente (KP)’s electronic medical records with KP’s SEER cancer registry, KP’s medical financial assistance program, and Social Security Administration’s supplemental income, disability, and mortality data, in a cohort of 17,000+ breast cancer patients followed longitudinally for 5+years. We will risk stratify breast cancer patients on ASCVD risk and evaluate the effect of primary prevention using advanced causal inference models exploring treatment effect heterogeneity from policy and decision-making perspectives. The study aims are Aim 1: Compare effectiveness of primary prevention pharmacological therapy on 1) cancer and CVD outcomes during chemotherapy and 2) cancer and CVD outcomes post- chemotherapy in adults with breast cancer. Aim 2: Evaluate the impact of primary prevention pharmacological therapy on financial toxicity and disability in adults with breast cancer. Aim 3: Evaluate the incremental medical expenditure and cost-effectiveness of primary prevention pharmacological therapy in adults with breast cancer using a net-benefit regression framework. Completion of this proposal will answer crucial questions to improve patient outcomes (1) Does primary prevention prevent future CVD events, improve/optimize cancer treatment and outcomes, reduce financial toxicity, disability, and cost? (2) How many patients need to be treated to avoid one adverse cardiovascular or cancer outcome? (2) What are the long-term effects of primary prevention? (3) Is primary prevention cost-effective or should society invest its resources elsewhere?

项目摘要我们的总体目标是识别和表征有患癌症治疗风险的癌症患者 - 相关的心脏毒性和减轻心血管功能障碍，同时优化癌症结局。进步在癌症的早期发现和治疗中，有5年的生存率提高了。但是，多模式癌治疗通常会导致心脏毒性。治疗期间的心血管疾病（CVD）事件可能会干扰随着它的分娩，从而导致了亚最佳癌症的结局，并增加了下游的发病率，成本和死亡。美国心脏协会（2019）指南建议与反抗基于动脉粥样硬化心血管疾病（ASCVD）风险。但是，尚不确定癌症患者的主要预防是否有所改善长期CVD结果。美国临床肿瘤学会（ASCO）（2017）指南已分类高剂量的蒽环类药物，靶向疗法以及其中的某些组合作为心脏毒性方案。原发性预防对患者对这种心脏毒性方案的影响尚不清楚。评估这些问题，我们将通过合并Kaiser Permanente（KP）的电子病历来创建一个唯一的数据集 KP的SEER癌症注册表，KP的医疗财务援助计划和社会保障行政管理的补充收入，残疾和死亡率数据在17,000多个乳腺癌中患者纵向跟踪5年以上。我们将冒着将乳腺癌患者分类为ASCVD风险和使用先进的因果推理模型探索治疗效果，评估初级预防的效果从政策和决策角度出发的异质性。研究目的是目标1：比较有效性 1）化学疗法期间癌症和CVD结局的一级预防药物治疗和2）乳腺癌成人化疗后的癌症和CVD结局。目标2：评估乳腺癌成年人财务毒性和残疾的一级预防药物治疗。目标3：评估初级预防的增量医疗支出和成本效益使用净效率回归框架的乳腺癌成年人的药理治疗。完成该建议将回答至关重要的问题以改善患者的预后（1）主要预防可以预防未来的CVD事件，改善/优化癌症治疗和结果，减少财务毒性，残疾和成本？（2）需要治疗多少患者以避免一种不良心血管或癌症结果？（2）初级预防的长期影响是什么？（3）主要预防成本效益或应社会在其他地方投资资源？