Effectiveness of Early Stage Prostate Cancer Treatment

早期前列腺癌治疗的有效性

• 批准号: 7942930
• 负责人: PETER R CARROLL
• 金额: $ 49.62万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7942930
• 关键词: Address; Affect; Aftercare; Age; Area; Award; Benefits and Risks; Body mass index; Brachytherapy; Cancer Control; Cancer Patient; Cancer Survivorship; Characteristics; Climacteric; Clinical; Communities; Controlled Clinical Trials; Cost Analysis; Data; Data Set; Disease; Early treatment; Effectiveness; External Beam Radiation Therapy; Health; Health system; High-Risk Cancer; Interview; Knowledge; Lead; Life Expectancy; Link; Malignant Neoplasms; Malignant neoplasm of prostate; Measures; Medicare; Modeling; Outcome; Patient Outcomes Assessments; Patients; Physicians; Policy Maker; Probability; Prostate; Prostatectomy; Publishing; Quality of life; Radiation therapy; Radical Prostatectomy; Recommendation; Registries; Reporting; Research; Salvage Therapy; Severities; Staging; Structure of base of prostate; Symptoms; Treatment Cost; Treatment Effectiveness; United States; Urology; base; cancer recurrence; cancer risk; cancer therapy; cohort; comparative; comparative effectiveness; compare effectiveness; cost; cost effectiveness; economic cost; effectiveness measure; effectiveness research; evidence base; health related quality of life; markov model; older patient; patient population; population based; predictive modeling; prospective; urologic

DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (05) Comparative Effectiveness Research and specific Topic 05-CA-104* Comparative Effectiveness Research on Cancer Treatment. Effectiveness of prostate cancer treatment has been previously evaluated by Markov models to measure Quality-adjusted Life Expectancy (QALE), but these comparisons did not use prospectively collected HRQOL outcome data to assign transition probabilities for HRQOL health states, and assess effects of such patient baseline function on comparative effectiveness, as we propose herein. Moreover, prior studies have not combined prospective multi-center HRQOL outcomes data with cost analyses to generate estimates of cost-effectiveness comparing the 3 most common contemporary treatments for early stage prostate cancer: prostatectomy, external radiotherapy, and brachytherapy. We propose to address this knowledge gap to facilitate treatment decisions. We hypothesize that baseline health-related quality of life (HRQOL) and clinical characteristics of early stage prostate cancer patients are pivotal determinants of the comparative effectiveness of different treatments. We propose to extend and analyze 2 prospective and one population based cohort including: The PROSTQA cohort, a prospective, multi-center cohort of 1201 early stage prostate cancer patients undergoing primary treatment [Sanda et al in NEJM 2008]; the CaPSURE HRQOL cohort, a prospective, multicenter cohort of 2067 early stage prostate cancer patients accrued before being treated at community-based Urology practices nationwide and for whom detailed cost data are available (reported in Wu et al J Urol 2008 and Wilson et al Cancer 2007); and by analysis of costs in 16,757 prostate cancer patients from SEER-Medicare treated by prostatectomy, radiotherapy or brachytherapy from 2003-2005. Three Aims are proposed as follows: Aim 1. To generate and validate models that use pre-treatment HRQOL, clinical status, and treatment details to predict HRQOL changes after each of the three most common primary treatments for early stage prostate cancer: prostatectomy, external radiotherapy, or brachytherapy Aim 2. To construct decision analytic Markov models to predict QALE of primary prostate cancer treatments using prospective cohort data to drive transition probabilities between HRQOL states. Aim 3. To characterize treatment-related costs and combine these with QALE in the Markov model framework to assess overall cost effectiveness as measured by incremental cost-effectiveness ratio (ICER), of prostatectomy, external radiotherapy, or brachytherapy for early stage prostate cancer. The proposed studies will enable combining unique cohorts having extensive HRQOL outcomes data from 3,268 prospectively followed patients with SEER-Medicare data from 16,757 patients to establish a dataset of 20,025 subjects for characterizing how differences in pre-treatment HRQOL and clinical details influence comparative cost effectiveness of different treatments for early stage prostate cancer. This application addresses broad Challenge Area (05) Comparative Effectiveness Research and specific Topic 05-CA-104* Comparative Effectiveness Research on Cancer Treatment: "The results of controlled clinical trials guide recommendations for many initial cancer treatments. But cancer treatments are also prevalent for cancers for which the evidence base in-complete, not applicable to the patient population (e.g. older patients) or non-existent. Prostate cancer is a prime, but not the only example, of this situation. Comparative effectiveness research in this area would use retrospective data and/or prospective interviews with patients, physicians and policy makers to assess the clinical benefits, risks and economic costs of commonly used treatment approaches and assess patient, physician and health system factors that effect dissemination of these treatment approaches." Quality of life is important to prostate cancer patients but efforts to compare different treatments have not previously incorporated differences in patients' quality of life prior to treatment in predicting how patients would do after treatment. We propose to compare effectiveness of different treatments for early prostate cancer (that has not yet spread) while taking into consideration differences in symptoms and quality of life that patients have before treatment.

描述（由申请人提供）：本申请涉及广泛的挑战领域 (05) 比较有效性研究和特定主题 05-CA-104* 癌症治疗的比较有效性研究。前列腺癌治疗的有效性之前已通过马尔可夫模型评估，以测量质量调整预期寿命 (QALE)，但这些比较并未使用前瞻性收集的 HRQOL 结果数据来分配 HRQOL 健康状态的转变概率，并评估此类患者基线的影响正如我们在此提出的那样，它的作用是比较有效性。此外，先前的研究尚未将前瞻性多中心 HRQOL 结果数据与成本分析相结合，以生成成本效益估计，以比较早期前列腺癌 3 种最常见的当代治疗方法：前列腺切除术、外部放射治疗和近距离放射治疗。我们建议弥补这一知识差距，以促进治疗决策。我们假设早期前列腺癌患者的基线健康相关生活质量（HRQOL）和临床特征是不同治疗方法比较效果的关键决定因素。我们建议扩展和分析 2 个前瞻性队列和一个基于人群的队列，包括： PROSTQA 队列，这是一个由 1201 名接受初级治疗的早期前列腺癌患者组成的前瞻性多中心队列 [Sanda 等人，2008 年 NEJM]； CaPSURE HRQOL 队列是一个前瞻性、多中心队列，由 2067 名早期前列腺癌患者组成，这些患者在全国范围内的社区泌尿科诊所接受治疗之前累积，并且可以获得这些患者的详细费用数据（Wu 等 J Urol 2008 和 Wilson 等 Cancer 中报告） 2007）；并分析了 2003 年至 2005 年 SEER-Medicare 接受前列腺切除术、放射治疗或近距离放射治疗的 16,757 名前列腺癌患者的费用。提出三个目标如下： 目标 1. 生成并验证使用治疗前 HRQOL、临床状态和治疗细节的模型来预测早期前列腺癌三种最常见的主要治疗（前列腺切除术、外部治疗）后 HRQOL 的变化。放射治疗或近距离放射治疗 目标 2. 构建决策分析马尔可夫模型，使用前瞻性队列数据来预测原发性前列腺癌治疗的 QALE，以驱动 HRQOL 状态之间的转换概率。目标 3. 描述与治疗相关的成本，并将其与马尔可夫模型框架中的 QALE 相结合，以评估早期前列腺癌的前列腺切除术、外部放射治疗或近距离放射治疗的增量成本效益比 (ICER) 所衡量的总体成本效益。拟议的研究将能够将具有来自 3,268 名前瞻性随访患者的广泛 HRQOL 结果数据的独特队列与来自 16,757 名患者的 SEER-Medicare 数据相结合，建立一个包含 20,025 名受试者的数据集，用于描述治疗前 HRQOL 和临床细节的差异如何影响治疗前的 HRQOL 和临床细节的差异如何影响比较成本效益早期前列腺癌的不同治疗方法。此应用程序解决了广泛的挑战领域 (05) 比较有效性研究和特定主题 05-CA-104* 癌症治疗的比较有效性研究：“对照临床试验的结果指导了许多初始癌症治疗的建议。但癌症治疗也普遍用于证据基础不完整、不适用于患者群体（例如老年患者）或不存在的癌症是该领域的比较有效性研究的主要但不是唯一的例子。回顾性数据和/或对患者、医生和政策制定者进行前瞻性访谈，以评估常用治疗方法的临床效益、风险和经济成本，并评估影响这些治疗方法传播的患者、医生和卫生系统因素。”生活质量对前列腺癌患者很重要，但之前比较不同治疗方法的努力并未将治疗前患者生活质量的差异纳入预测患者治疗后的表现。我们建议比较早期前列腺癌（尚未扩散）的不同治疗方法的有效性，同时考虑患者治疗前症状和生活质量的差异。