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

• 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
• 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

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?

项目概要 我们的首要目标是识别和描述有癌症治疗风险的癌症患者 - 相关的心脏毒性并减轻心血管功能障碍，同时优化癌症结果。进展 癌症的早期发现和治疗提高了 5 年生存率。然而，多模式癌症 治疗常常导致心脏毒性。治疗期间的心血管疾病 (CVD) 事件可能会干扰 其交付，从而导致次优的癌症结果并增加下游发病率、成本和 死亡。美国心脏协会 (2019) 指南建议采用抗 基于动脉粥样硬化的高危人群的高脂血症和抗高血压药物 心血管疾病（ASCVD）风险。然而，尚不确定癌症患者的一级预防是否有所改善 长期 CVD 结果。美国临床肿瘤学会 (ASCO) (2017) 指南已将 高剂量蒽环类药物、靶向治疗以及这些药物的某些组合，作为心脏毒性治疗方案。这 患者一级预防对此类心脏毒性治疗方案的影响尚不清楚。来评价这些 问题，我们将通过合并 Kaiser Permanente (KP) 的电子病历来创建一个独特的数据集 KP 的 SEER 癌症登记处、KP 的医疗财务援助计划和社会保障 政府在 17,000 多名乳腺癌患者队列中提供的补充收入、残疾和死亡率数据 患者纵向随访5年以上。我们将对乳腺癌患者进行 ASCVD 风险分层，并 使用先进的因果推理模型评估一级预防的效果，探索治疗效果 政策和决策角度的异质性。研究目的是目标 1：比较有效性 一级预防药物治疗对 1) 化疗期间癌症和 CVD 结局的影响以及 2) 成人乳腺癌化疗后的癌症和心血管疾病结局。目标 2：评估影响 对成年乳腺癌患者经济毒性和残疾的一级预防药物治疗。 目标3：评估增量医疗支出和一级预防的成本效益 使用净效益回归框架对成人乳腺癌进行药物治疗。完成 该提案将回答改善患者治疗效果的关键问题（1）一级预防是否可以预防 未来的 CVD 事件，改善/优化癌症治疗和结果，减少经济毒性、残疾和 成本？ (2) 有多少患者需要接受治疗才能避免一种不良的心血管或癌症结果？ (2) 一级预防的长期效果是什么？ (3) 一级预防是否具有成本效益或应该 社会将资源投资到其他地方？