Using SWOG-Medicare database to evaluate long-term toxicities of cancer survivors

使用 SWOG-Medicare 数据库评估癌症幸存者的长期毒性

• 批准号: 8997455
• 负责人: DAWN HERSHMAN
• 金额: $ 31.87万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-02-15 至 2018-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8997455
• 关键词: Adverse effects; Age; Androgens; Area; Breast; Cancer Survivor; Cancer Survivorship; Cardiovascular system; Cessation of life; Clinical; Clinical Treatment; Clinical Trials; Clinical Trials Cooperative Group; Clinical Trials Database; Common Terminology Criteria for Adverse Events; Comorbidity; Current Procedural Terminology Codes; Data; Databases; Demographic Factors; Diabetes Mellitus; Diagnosis; Dose; Eligibility Determination; Enrollment; Evaluation; Finasteride; Gender; Health; Health Insurance Portability and Accountability Act; Healthcare Common Procedure Coding System; Heterogeneity; Hospitalization; Hypertension; ICD-9; Incidence; Institutional Review Boards; Intravenous; Kidney; Late Effects; Link; Long-Term Survivors; Malignant Neoplasms; Malignant neoplasm of prostate; Medical; Medical Surveillance; Medicare; Medicare claim; Methodology; Neurologic; Non-Small-Cell Lung Carcinoma; Observational Study; Oncology Group; Oral; Outcome; Patients; Pelvic Cancer; Pharmaceutical Preparations; Placebos; Platinum Compounds; Population; Prevention trial; Prognostic Factor; Prostate; Race; Radiation; Radiation therapy; Randomized; Randomized Clinical Trials; Recurrence; Research; Research Personnel; Resources; Risk; Sampling; Selection Bias; Southwest Oncology Group; Survivors; Toxic effect; Treatment Factor; acute toxicity; administrative database; base; cancer clinical trial; cancer recurrence; cancer therapy; chemotherapy; cost; demographics; deprivation; follow-up; gastrointestinal; high risk men; improved; malignant breast neoplasm; novel strategies; population based; prognostic; prospective; prostate cancer prevention; subcutaneous; survival outcome; taxane; tool; treatment duration; treatment effect; treatment group; treatment trial; tumor

DESCRIPTION (provided by applicant): There are over 12 million cancer survivors in the UC. Cancer survivorship and understanding late effects of cancer therapy is a high priority area. The linkage of the powerful SWOG clinical trial database to Medicare claims data provides a unique opportunity to evaluate late effects of therapy, and may establish a mechanism for identifying differences in outcomes between treatment groups after the clinical trial follow-up ends. We propose to use a database that has linked patients enrolled on SWOG clinical treatment and prevention trials where detailed information on demographics, tumor details, prognostic factors, clinical factors, treatment type (intravenous, subcutaneous and oral) and dose received, short term toxicities during the treatment period, recurrence and survival outcomes are captured with Medicare claims data (based on ICD-9, HCPCS, and CPT codes) which can provide long-term follow-up with underlying illnesses, comorbid conditions, new diagnoses, subsequent treatment, hospitalizations and costs/resource utilization associated with treatment. For the specific aims of our proposal, we will use the SWOG-Medicare linked database to determine the long term cardiovascular, hematologic, gastrointestinal, renal, endocrinologic and neurologic complications of (a) patients with prostate cancer randomized to continuous vs intermittent androgen deprivation (b) patients with prostate cancer treated with and without androgen deprivation (c) patients with breast and prostate cancer treated with and without taxanes (d) patients with non-small cell lung cancer treated with and without platinum agents (e) patients with pelvic cancer treated with chemotherapy and radiation vs. radiation alone. For each of these sub-aims, we will examine how these complications vary by pre-existing co-morbidities, such as diabetes and hypertension, as well as clinical and demographic factors, and examine the relationship between short term toxicities assessed during therapy on a clinical trial, as characterized by the Common Toxicity Criteria (CTC-AE), and long-term toxicities. Using the unique and valuable linked Medicare claims database with the NCI clinical trials database of the Southwest Oncology Group, we can perform analyses that overcome limitations of previously conduced population based research that utilized the SEER-Medicare database alone. If we can better predict who is at greatest risk for late toxicity, and who is not, we can improve long term outcomes for the growing population of cancer survivors

描述（由申请人提供）：UC中有超过1200万癌症幸存者。癌症存活率和了解癌症治疗的晚期效应是一个高度优先的领域。强大的SWOG临床试验数据库与医疗保险索赔数据的链接提供了评估治疗后期效果的独特机会，并可能建立一种机制，用于在临床试验随访结束后识别治疗组之间结果的差异。我们建议使用一个数据库，该数据库将参加SWOG临床治疗和预防试验的患者联系起来，其中包含人口统计学、肿瘤详情、预后因素、临床因素、治疗类型等详细信息（静脉、皮下和口服）和接受的剂量、治疗期间的短期毒性、复发和生存结局与Medicare索赔数据一起收集（基于ICD-9、HCPCS和CPT代码），可以提供与基础疾病、共病、新诊断、后续治疗、住院和与治疗相关的成本/资源利用的长期随访。具体目标是 我们的建议，我们将使用SWOG-Medicare链接数据库来确定长期心血管，血液，胃肠道，肾脏，内分泌和神经系统并发症：（a）前列腺癌患者随机分配至连续与间歇雄激素剥夺组（B）前列腺癌患者接受和不接受雄激素剥夺治疗（c）乳腺癌和前列腺癌患者接受和不接受紫杉烷类治疗（d）用和不用铂剂治疗的非小细胞肺癌患者（e）用化疗和放射治疗的骨盆癌患者与单独放射治疗的骨盆癌患者。对于这些子目标中的每一个，我们将检查这些并发症如何因预先存在的合并症（如糖尿病和高血压）以及临床和人口统计学因素而变化，并检查临床试验治疗期间评估的短期毒性（以通用毒性标准（CTC-AE）为特征）与长期毒性之间的关系。使用独特而有价值的关联医疗保险索赔数据库与西南肿瘤组的NCI临床试验数据库，我们可以进行分析，克服以前单独使用SEER-医疗保险数据库进行的基于人群的研究的局限性。如果我们能更好地预测谁是晚期毒性的最大风险，谁不是，我们就能改善不断增长的癌症幸存者的长期预后。