Comparative Effectiveness of Surgery vs Stereotactic Radiation Therapy for Stage I Lung Cancer

手术与立体定向放射治疗 I 期肺癌的疗效比较

• 批准号: 10579175
• 负责人: Benjamin D Kozower
• 金额: $ 62.66万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-24 至 2027-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10579175
• 关键词: Address; Adverse event; Aftercare; Benchmarking; Cancer Etiology; Cancer Patient; Caring; Characteristics; Clinical; Cohort Studies; Comparative Study; Data; Databases; Disease; Disease-Free Survival; Disparate; Early Diagnosis; Equipoise; Evidence based treatment; Goals; Information Systems; Institution; Investigation; Knowledge; Light; Malignant Neoplasms; Malignant neoplasm of lung; Measurement; Modeling; Morbidity - disease rate; National Comprehensive Cancer Network; Non-Small-Cell Lung Carcinoma; Operative Surgical Procedures; Outcome; Patient Care; Patient Outcomes Assessments; Patient-Centered Care; Patients; Population Study; Provider; Publications; Publishing; Radiation Oncology; Radiation therapy; Randomized; Randomized, Controlled Trials; Recommendation; Research Design; Retrospective Studies; Sample Size; Scanning; Selection Bias; Societies; Surgical Oncology; Techniques; Thoracic Surgical Procedures; Treatment outcome; Work; X-Ray Computed Tomography; cohort; comorbidity; comparative effectiveness; comparative effectiveness study; compare effectiveness; design; experience; improved; individual patient; lung cancer screening; medical specialties; mortality; patient advocacy group; personalized medicine; pragmatic study; predictive modeling; preference; premature; prospective; recruit; systematic review; trial comparing; tumor; web-based tool

Non-small cell lung cancer (NSCLC) is the leading cause of cancer related morbidity and mortality in the U.S. With the increasing use of computed tomography scans and lung cancer screening, tumors are increasingly being detected at stage I disease, conferring a greater than 70% likelihood of cure. Surgery has been the traditional treatment for stage I NSCLC. However, population-based studies demonstrate a rapid increase in stereotactic body radiation therapy (SBRT) over the past decade. Retrospective studies comparing surgery and SBRT, including several publications from our group, have been hampered by relatively small sample sizes, lack of patient reported outcomes, and sparse information on comorbidities and cancer-related outcomes. Consequently, a recent systematic review concluded, “there is a need to compare both treatments in large prospective trials”. Unfortunately, multiple attempted randomized controlled trials comparing surgery to SBRT have failed to accrue and closed prematurely due to specialty bias and perceived lack of equipoise. Furthermore, our previous work has demonstrated that individual patient characteristics are crucial in the choice of therapy. In the absence of prospective comparative studies, treatment allocation is largely directed by institutional experience, retrospective data, and provider opinion. The lack of evidence-based treatment allocation in patients with stage I lung cancer remains a critical unmet need. To address this fundamental gap in knowledge, we will perform a prospective, pragmatic, multi-center cohort study to compare the effectiveness of surgery and SBRT for stage I NSCLC. This pragmatic study design is ideally suited to provide actionable results. Aim 1: To compare the effectiveness of surgery versus stereotactic body radiation therapy (SBRT) on stakeholder selected short and long-term outcomes in patients with clinical stage I lung cancer. Aim 1a: To compare 3-year disease-free survival (DFS) between surgery and SBRT. We will compare long-term DFS using propensity score matched cohorts. We hypothesize that SBRT will lead to fewer and less severe treatment- related complications, while surgery will result in longer DFS. Aim 1b: To compare patient reported outcomes (PRO) between surgery and SBRT. We will compare short and long-term PRO in propensity-matched cohorts using the Patient Reported Outcomes Measurement Information System. We hypothesize that SBRT will result in better short-term PRO with equivalent long-term PRO. Aim 2: To develop and validate prediction models for treatment outcomes for an individual patient with stage I lung cancer. In prospectively assembled cohorts of patients undergoing surgery or SBRT for stage I lung cancer, we will predict long-term DFS and PRO for an individual patient using regression techniques. These models will be validated and presented as a web-based tool for patients with stage I NSCLC. Our proposal will create a benchmark for personalized treatment allocation in lung cancer and provide actionable results to improve care for Stage I NSCLC patients.

非小细胞肺癌（NSCLC）是美国相关发病率和死亡率的主要原因 随着计算机断层扫描和肺癌筛查的越来越多的使用，肿瘤越来越多 在I阶段疾病中发现，会议的治愈可能性大于70％。手术一直是 阶段INSCLC的传统治疗方法。但是，基于人群的研究表明 在过去的十年中，立体定向的身体放射疗法（SBRT）。回顾性研究比较手术和 SBRT，包括我们小组的几本出版物，被相对较小的样本量所阻碍，缺乏 患者报告的结果，以及有关合并症和与癌症相关结果的稀疏信息。 因此，最近的系统评论得出结论：“有必要比较两种治疗方法 前瞻性试验”。不幸的是，将手术与SBRT进行比较的多次尝试随机对照试验 由于专业偏见和缺乏平衡性，未能产生并过早关闭。此外， 我们以前的工作表明，个体患者特征对于选择治疗至关重要。 缺乏前瞻性比较研究，治疗分配在很大程度上是由机构指导的 经验，回顾性数据和提供商的意见。患者缺乏基于证据的治疗分配 伴随I期，肺癌仍然是一个至关重要的未满足需求。为了解决这一知识的基本差距，我们将 进行前瞻性，务实的多中心队列研究，以比较手术和SBRT的有效性 对于I阶段NSCLC。这种务实的研究设计非常适合提供可行的结果。 目的1：比较手术与立体定向的身体放射疗法（SBRT）的有效性 利益相关者在临床I期肺癌患者中选择了短期和长期结局。 AIM 1A： 比较手术和SBRT之间的3年无病生存期（DFS）。我们将比较长期DFS 使用倾向得分匹配的队列。我们假设SBRT会导致较少和不太严重的治疗 - 相关并发症，而手术将导致更长的DF。目标1B：比较患者报告的结果 （Pro）在手术和SBRT之间。我们将比较有希望匹配的队列中的短期和长期职业 使用患者报告的结果测量信息系统。我们假设SBRT会导致 在更好的短期专业中，具有同等的长期专业。 目标2：为个体患者开发和验证治疗结果的预测模型 第一阶段的肺癌。在预期的接受手术或SBRT的患者中， 肺癌，我们将使用回归技术为个体患者预测长期DFS和PRO。这些 模型将被验证并作为基于Web的工具，适用于I级NSCLC患者。我们的建议将 为肺癌的个性化治疗分配创建基准，并提供可行的结果 改善对I阶段NSCLC患者的护理。