Understanding the Guideline-Discordant Use of Bone Modifying Agents in Prostate Cancer

了解骨修饰剂在前列腺癌中的使用与指南不一致

• 批准号: 10370432
• 负责人: Aaron P Mitchell
• 金额: $ 8.85万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10370432
• 关键词: Address; Affect; Benefits and Risks; Bone necrosis; Breast; Cancer Patient; Caring; Castration; Clinical; Cost Analysis; Cost Savings; Data; Data Analyses; Disadvantaged; Electrolytes; Equilibrium; Ethnic group; Financial cost; Fracture; Future; Guidelines; Health Care Costs; Health system; High Prevalence; Intervention; Jaw; Kidney Failure; Knowledge; Lead; Link; Low income; Malignant neoplasm of prostate; Measures; Medicare; Metastatic Prostate Cancer; Multiple Myeloma; National Comprehensive Cancer Network; Newly Diagnosed; Outcome; Patient-Focused Outcomes; Patients; Pattern; Pharmaceutical Preparations; Physicians' Offices; Prevalence; Provider; Quality of Care; Quality of life; Resources; Risk; Socioeconomic Factors; Time; Time trend; Treatment Cost; Work; Zoledronic Acid; barrier to care; bone; cancer care; cancer type; castration resistant prostate cancer; cost; cost effective; design; experience; fracture risk; improved; improved functioning; men; pain reduction; prevent; prostate cancer risk; provider factors; racial and ethnic; side effect; therapy design

PROJECT SUMMARY Bone-modifying agents (BMAs) can improve quality-of-life in metastatic prostate cancer. The BMAs zoledronic acid and denosumab prevent bone fractures among men with metastatic, castration-resistant prostate cancer (mCRPC), resulting in reduced pain and improved function. However, BMAs can cause serious side effects. Because BMAs do not prevent fractures among men with metastatic, castration-sensitive prostate cancer (mCSPC), the risk/benefit balance does not support BMA use for these patients. For these reasons, the National Comprehensive Cancer Network Guidelines recommend for the use of BMAs in mCRPC, and against their use in mCSPC. Patient outcomes may therefore be adversely affected by both BMA underuse among patients with mCRPC and by overuse among patients with mCSPC. However, little is known about the real- world use of BMAs in prostate cancer. To determine whether BMA underuse and/or overuse are significant problems, the utilization patterns of BMAs for prostate cancer must first be understood. BMA drugs also have important differences in value – benefits relative to financial cost. Zoledronic acid is cost-effective, but denosumab, which is much more expensive, is not. The use of denosumab instead of zoledronic acid may therefore result in avoidable costs to patients and the health system. To address these knowledge gaps, we propose to describe real-world use of BMAs in prostate cancer using SEER-Medicare data. We will identify two key patient groups: those with mCRPC, among whom BMA use is recommended, and those with mCSPC, among whom BMA use is discouraged and would constitute overuse. We will determine the prevalence of BMA therapy within each group and characterize the patient and provider factors associated with underuse and overuse. We will also assess whether increased denosumab use has resulted in excess financial costs to patients or to Medicare. Aim 1: Measure the prevalence of underuse and overuse of bone-modifying agents in prostate cancer. To measure potential underuse, we will use SEER-Medicare data to identify patients with mCRPC and determine their receipt of BMAs (Aim 1A). To measure overuse (Aim 1B), we will identify patients newly diagnosed with mCSPC and determine receipt of BMAs. Aim 2: Identify and describe patient and provider factors associated with underuse and overuse of bone-modifying agents. We will use SEER-Medicare data to identify key patient socioeconomic factors and provider organizational factors associated with BMA underuse (Aim 2A) and overuse (Aim 2B). Aim 3: Evaluate changes in utilization of denosumab and associated costs. We will assess temporal trends in the relative use of denosumab vs. zoledronic acid (Aim 3A) and estimate resulting costs to patients and to Medicare (Aim 3B). Impact: This study will increase our understanding of BMA utilization in prostate cancer. Study results may lead to future interventional work to improve prostate cancer outcomes by reducing BMA underuse and overuse.

项目摘要 骨改良剂（BMA）可以改善转移性前列腺癌的生活​​质量。 BMA ZOLEDRONIC 酸和denobab预防转移性，耐castration前列腺癌的男性骨折 （MCRPC），导致疼痛减轻和功能改善。但是，BMA会引起严重的副作用。 因为BMAS不能预防转移性，cast割敏感的前列腺癌的男性骨折 （MCSPC），风险/福利余额不支持这些患者的BMA使用。由于这些原因， 国家综合癌症网络指南建议在MCRPC中使用BMA，并反对 它们在MCSPC中的使用。因此 MCRPC患者和MCSPC患者的过度使用。但是，关于实地知之甚少 世界在前列腺癌中使用BMA。确定BMA是否不足和/或过度使用是重要的 问题，必须首先了解BMA的BMA的利用模式。 BMA药物也有 价值的重要差异 - 相对于财务成本的收益。唑来膦酸具有成本效益，但 denosumab的价格要贵得多，不是。使用denosumab代替唑来膦酸的使用可能 因此，导致患者和卫生系统的可避免成本。为了解决这些知识差距，我们 使用SEER-MEDICARE数据来描述BMA在前列腺癌中使用现实世界的建议。我们将确定两个 关键患者组：使用MCRPC的患者，其中建议使用BMA，而MCSPC的患者则为 在其中使用BMA，不建议使用，并将构成过度使用。我们将确定患病率 每个组内的BMA治疗，并表征与不足有关的患者和提供者的因素 和过度使用。我们还将评估是否增加了地诺巴的使用是否导致了过多的财务成本 病人或医疗保险。目的1：测量不足和过度使用骨修改的患病率 前列腺癌的代理。为了衡量潜在的无法使用，我们将使用Seer-Medicare数据来识别 患有MCRPC的患者并确定其BMA的收到（AIM 1A）。要测量过度使用（AIM 1B），我们将 识别新诊断为MCSPC的患者并确定BMA的接收。目标2：识别并描述 患者和提供者的因素与骨修改药物的不足和过度使用有关。我们将 使用SEER-MEDICARE数据来识别关键的患者社会经济因素和提供者组织因素 与BMA不足（AIM 2A）和过度使用（AIM 2B）相关。目标3：评估利用率的变化 Denosumab及相关费用。我们将评估denosumab V的相对使用的临时趋势。 唑来膦酸（AIM 3A），并估计患者和Medicare的成本（AIM 3B）。影响：这个 研究将增加我们对前列腺癌中BMA利用的理解。研究结果可能会导致未来 通过减少BMA不足和过度使用来改善前列腺癌预后的介入工作。

项目成果

Real-World Use of Bone-Modifying Agents in Metastatic Castration-Sensitive Prostate Cancer.

骨改性剂在转移性去势敏感前列腺癌中的实际应用。

• DOI: 10.1093/jnci/djab196
• 发表时间: 2022
• 期刊: Journal of the National Cancer Institute
• 作者: Mitchell,AaronP;MishraMeza,Akriti;Panageas,KatherineS;Lipitz-Snyderman,Allison;Bach,PeterB;Morris,MichaelJ
• 通讯作者: Morris,MichaelJ