Systematic evaluation of predicted outcomes and costs to inform clinical and policy decision making for emerging postmastectomy radiotherapies

对预测结果和成本进行系统评估，为新兴乳房切除术后放射治疗的临床和政策决策提供信息

• 批准号: 9324723
• 负责人: Rui Zhang
• 金额: $ 19.32万
• 依托单位: LOUISIANA STATE UNIV A&M COL BATON ROUGE
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-01 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9324723
• 关键词: Acute; Adverse effects; Advisory Committees; Applications Grants; Bolus Infusion; Breast; Breast Cancer Patient; Breast Cancer Treatment; Breast Cancer survivor; Chronic; Clinical; Clinical Trials; Computer Simulation; Conformal Radiotherapy; Cost Effectiveness Analysis; Cost Savings; Data; Decision Making; Development Plans; Diagnosis; Disease; Dose; Economic Models; Educational workshop; Electrons; Evaluation; Expenditure; Female Breast Carcinoma; Goals; Gray unit of radiation dose; Health Care Costs; Heart; K-Series Research Career Programs; K22 Award; Knowledge; Learning; Left; Life; Literature; Long-Term Survivors; Lymph Node Involvement; Malignant Neoplasms; Mastectomy; Methods; Microscopic; Modality; Myocardial Ischemia; Normal tissue morphology; Organ; Outcome; Outcome Study; Patient Care; Patients; Photons; Policies; Population Research; Prevalence; Quality of life; Radiation Tolerance; Radiation therapy; Reading; Recurrence; Research; Research Personnel; Residual Tumors; Risk; Sampling; Side; Supervision; Techniques; Technology; Testing; Toxic effect; Training; Training Support; Translating; Treatment Cost; Treatment outcome; Treatment-related toxicity; United States; Woman; anatomic imaging; base; cancer site; career; career development; clinical decision-making; cost; cost effectiveness; cost-effectiveness evaluation; effective therapy; evidence base; experience; improved; improved outcome; malignant breast neoplasm; markov model; meetings; mortality; multidisciplinary; neoplastic cell; new technology; novel strategies; outcome prediction; personalized approach; proton therapy; public health relevance; radiosensitive; reconstruction; skills; treatment planning; treatment strategy; tumor

 DESCRIPTION (provided by applicant): Breast cancer is the second most common cancer among women and there are about 2.8 million breast cancer survivors in the US. A mastectomy is highly recommended for local advanced patients, and postmastectomy radiation therapy (PMRT) is a major and effective treatment method for these patients. However, acute and chronic radiogenic side effects can seriously decrease patients' quality of life after radiotherapy Among various cancer sites, expenditures for female breast cancer remain as the highest. New technologies keep disseminating into radiotherapy field and are used to treat breast cancer patients. Usually the more advanced radiotherapy techniques are more expensive to deliver, but they may yield better survival and cost savings due to lower toxicities. Currently clinical and policy decision making is challenging because of the many possible treatment strategies, the rapid technological advancement of radiotherapy, escalating costs, and an insufficient evidence base. Our long term research goal is improve treatment outcomes for breast cancer patients. This project will focus on the impact of advanced radiotherapy modalities on postmastectomy patients, and our hypothesis is that for left sided postmastectomy patients, the predicted risk of radiogenic side effects and the total treatment costs can be significantly reduced by using advanced-technology radiotherapies. In aim 1, retrospective in-silico clinical trial will be performed to compare the predicted outcomes after various modalities for a sample of left sided PMRT patients. The cost-effectiveness analysis of these modalities will be performed in aim 2 by using Markov model and risk values from aim 1 and literature. My long term career goal is to become an independent investigator and leader of a multi- disciplinary team focused on breast cancer. This K22 award will provide me with the necessary training and support to accomplish the following goals: 1) to obtain more hands-on population- based research experience; 2) to learn cost-effectiveness analysis of different radiotherapy modalities for breast cancer treatment; 3) to translate current risk/cost-effectiveness calculations into daily clinical practic; 4) to develop the skills and knowledge needed to be an independent investigator. To achieve these goals, I have proposed a detailed career development plan, including taking short courses and workshops, attending seminars and professional meetings, supervised reading, meetings with my advisory committee regularly to discuss knowledge deficits and training progress, and obtaining practice experience by working on proposed research plan. This K22 research will form the basis for a study to develop a more personalized approach to treat all breast cancer patients (whole breast, partial breast and postmastectomy patients): compare existing techniques and develop novel approaches to improve outcome, taking into account the risk of side effects and cost-effectiveness. This will be proposed in an R01 grant application 1 year before the end of the K award.

 描述（由申请人提供）：乳腺癌是女性中第二常见的癌症，在美国约有280万乳腺癌幸存者。乳腺切除术是高度推荐的局部晚期患者，乳腺切除术后放射治疗（PMRT）是这些患者的主要和有效的治疗方法。然而，急性和慢性放射性副作用会严重降低患者的生活质量，在各种癌症部位中，女性乳腺癌的支出仍然是最高的。新技术不断渗透到放射治疗领域，用于治疗乳腺癌患者。通常，更先进的放射治疗技术更昂贵，但由于毒性较低，它们可能会产生更好的生存率和成本节约。目前，临床和政策决策是具有挑战性的，因为许多可能的治疗策略，放射治疗的快速技术进步，不断上升的成本，以及证据基础不足。我们的长期研究目标是改善乳腺癌患者的治疗效果。该项目将重点关注先进的放射治疗方式对乳房切除术后患者的影响，我们的假设是，对于左侧乳房切除术后患者，使用先进技术的放射治疗可以显着降低放射性副作用的预测风险和总治疗费用。在目标1中，将进行回顾性计算机模拟临床试验，以比较左侧PMRT患者样本的各种模式后的预测结局。将在目标2中使用马尔可夫模型和目标1和文献中的风险值对这些模式进行成本-效果分析。我的长期职业目标是成为一名独立的研究者和一个专注于乳腺癌的多学科团队的领导者。这个K22奖将为我提供必要的培训和支持，以实现以下目标：1）获得更多的基于人群的实践研究经验; 2）学习乳腺癌治疗不同放射治疗方式的成本效益分析; 3）将当前的风险/成本效益计算转化为日常临床实践; 4）将现有的风险/成本效益计算转化为临床实践。4）发展成为独立调查员所需的技能和知识。为了实现这些目标，我提出了一个详细的职业发展计划，包括参加短期课程和工作坊，参加研讨会和专业会议，监督阅读，定期与我的顾问委员会开会讨论知识赤字和培训进度，并通过拟议的研究计划获得实践经验。这项K22研究将为一项研究奠定基础，该研究旨在开发一种更个性化的方法来治疗所有乳腺癌患者（全乳房，部分乳房和乳房切除术后患者）：比较现有技术并开发新方法来改善结果，同时考虑副作用和成本效益的风险。这将在K奖结束前1年在R 01补助金申请中提出。