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

基本信息

批准号：
8620619
负责人：
DAWN HERSHMAN
金额：
$ 31.48万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-02-15 至 2017-01-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8620619
关键词：
Acute 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 Prognostic Factor Prostate Race Radiation Radiation therapy Randomized Randomized Clinical Trials Recurrence Research Research Personnel Resources Risk Sampling Selection Bias Southwest Oncology Group Survivors Taxane Compound Toxic effect Treatment Factor administrative database base 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 taxane tool treatment duration treatment effect tumor

项目摘要

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。癌症的生存和了解癌症治疗的后期作用是高优先级。强大的SWOG临床试验数据库与Medicare索赔数据的联系为评估治疗后期影响提供了独特的机会，并可能建立一种机制来识别临床试验随访后治疗组之间结果差异的机制。 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代码）可以提供长期随访，并具有潜在的疾病，合并症，新诊断，随后的治疗，住院和与治疗相关的成本/资源利用。为了具体目的我们的提议，我们将使用Swog-Medicare链接数据库来确定（a）（a）前列腺癌患者的长期心血管，血液学，胃肠道，肾脏，肾脏，内分泌学和神经学上的并发症，可随机癌症随机与持续的患者与乳腺癌治疗癌症患者持续降级，并治疗癌症患者（b）患者（B）前列腺癌症患者（b）前列腺癌症患者（b）前列腺治疗（b）患者（B）没有铂和没有铂药治疗的非小细胞肺癌患者（d）患有非小细胞肺癌的患者（E）单独接受化学疗法和放射治疗的骨盆癌患者。对于这些子aim，我们将研究这些并发症如何因糖尿病和高血压以及临床和人口统计学因素等先前存在的共生性以及临床和人口统计学因素的变化，并研究临床试验治疗期间在治疗期间评估的短期毒性之间的关系，如常见毒性标准（CTC-EA）的特征（CTC-EA）和长期毒性和长期毒性。使用独特而有价值的链接Medicare Simpare数据库，以及西南肿瘤学组的NCI临床试验数据库，我们可以进行分析，以克服对先前基于人群的研究的限制，这些研究仅利用Seer-Medicare数据库。如果我们能够更好地预测谁对晚期毒性有最大的风险，而谁没有，那么我们可以改善癌症幸存者不断增长的人群的长期结局