Postmarketing Surveillance of Toxicities Associated with Cancer Chemotherapy

与癌症化疗相关的毒性的上市后监测

基本信息

批准号：
7768457
负责人：
XIANGLIN DU
金额：
$ 20.9万
依托单位：
UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-04-01 至 2012-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7768457
关键词：
Postmarketing Surveillance Toxicities Associated Cancer

项目摘要

DESCRIPTION (provided by applicant): DESCRIPTION (provided by applicant): Chemotherapy is effective in prolonging patient survival and decreasing tumor recurrence for an increasing number of cancers. Almost all chemotherapy agents are associated with toxicity, which is the prime factor limiting their use. Current information on toxicity from different types of chemotherapy usually comes from randomized controlled trials. However, there have been few population-based assessments of toxicities associated with cancer chemotherapy in the community. Our studies on the external and internal validity of Medicare claims for chemotherapy suggest that Medicare claims data provide valid information on cancer chemotherapy. We have also demonstrated the feasibility of using Medicare claims data to assess population-based hospitalizations for serious toxicities associated with breast cancer chemotherapy. We propose to use the updated National Cancer Institute's SEER (Surveillance, Epidemiology, and End Results)-Medicare linked data to address in-depth issues on the postmarketing surveillance of short- and longterm toxicities associated with chemotherapy for several major cancers that are often treated with chemotherapy, including breast, ovarian, colorectal, and lung cancers. Our specific aims are: 1) to determine the rate of hospitalization for short-term toxicity associated with chemotherapy administration; 2) to determine the mortality associated with hospitalization for short-term toxicity from chemotherapy; 3) to determine the incidence of long-term or late-stage toxicity associated with chemotherapy use (e.g., cardiac dysfunction, bone marrow failure, second malignancies, and cognitive impairment); 4) to determine how hospitalization, mortality and long-term toxicity vary with type of cancer, and type and amount of chemotherapy; and 5) to examine how hospitalization, mortality and long-term toxicity vary by age, gender, ethnicity, co-morbidity, socioeconomic factors, geographical area, hospital and physician characteristics. These analyses will be conducted in a large population-based cohort of over 300,000 patients diagnosed with the above cancers at age 65 or older from 1992 to 2002 in thirteen SEER areas, over 30% of whom receive chemotherapy. Currently, there is no systematic approach for evaluating long-term toxicity of the marketed drugs. The proposed innovative use of the nationwide, population-based computerized Medicare claims data offer a promising and less expensive way of obtaining information on postmarketing drug toxicity in community settings. This database is especially unique for studying cancer chemotherapy and its toxicity because chemotherapy is among the few drugs that are covered by Medicare for past several decades.

描述（由申请人提供）：描述（申请人提供）：化学疗法可有效延长患者的生存和减少肿瘤复发的癌症，以增加癌症的数量。几乎所有的化学疗法剂都与毒性有关，这是限制其使用的主要因素。当前有关来自不同类型化疗的毒性的信息通常来自随机对照试验。但是，对社区中与癌症化学疗法相关的毒性的基于人群的评估很少。我们对Medicare对化学疗法的外部和内部有效性的研究表明，Medicare主张数据提供了有关癌症化学疗法的有效信息。我们还证明了使用Medicare索赔数据来评估与乳腺癌化学疗法相关的严重毒性的可行性。我们建议使用最新的国家癌症研究所的先知（监视，流行病学和最终结果） - Medicare将数据连接起来，以解决有关与几种主要癌症相关的短期和长期毒性监测的深入问题，这些毒物与几种主要癌症有关，这些癌症经常接受化学治疗，包括乳房，Ovarian，Ovarian，Colorectal，lunung and Lung anung and cancers and overaption comperation。我们的具体目的是：1）确定与化疗给药相关的短期毒性的住院率； 2）确定与化学疗法短期毒性相关的住院死亡率； 3）确定与化疗相关的长期或晚期毒性的发生率（例如心脏功能障碍，骨髓衰竭，第二个恶性肿瘤和认知障碍）； 4）确定住院，死亡率和长期毒性如何随癌症类型以及化学疗法的类型和数量而变化； 5）检查住院，死亡率和长期毒性如何因年龄，性别，种族，合并症，社会经济因素，地理区域，医院和医师特征而变化。这些分析将在1992年至2002年以上诊断出的30万名患者的300,000名患者中，从1992年至2002年的13个SEER地区进行，其中30％以上的患者将进行这些分析，其中30％以上接受了化学疗法。当前，没有系统的方法来评估市场药物的长期毒性。在全国范围内，基于人群的计算机化医疗保险索赔的创新使用数据提供了一种有前途且较便宜的方式，可在社区环境中获取有关售后药物毒性的信息。该数据库对于研究癌症化学疗法及其毒性特别是独一无二的，因为化学疗法是过去几十年来医疗保险涵盖的少数药物之一。