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（由申请人提供）：对于越来越多的癌症，化疗可有效延长患者生存期并减少肿瘤复发。几乎所有化疗药物都具有毒性，这是限制其使用的主要因素。目前有关不同类型化疗毒性的信息通常来自随机对照试验。然而，社区中很少有针对癌症化疗相关毒性的基于人群的评估。我们对医疗保险化疗索赔的外部和内部有效性的研究表明，医疗保险索赔数据提供了有关癌症化疗的有效信息。我们还证明了使用医疗保险索赔数据来评估基于人群的乳腺癌化疗相关严重毒性住院治疗的可行性。我们建议使用更新的国家癌症研究所的 SEER（监测、流行病学和最终结果）-医疗保险相关数据来解决与经常治疗的几种主要癌症的化疗相关的短期和长期毒性的上市后监测的深入问题化疗，包括乳腺癌、卵巢癌、结直肠癌和肺癌。我们的具体目标是：1）确定因化疗相关的短期毒性而住院的比率； 2) 确定与化疗短期毒性住院相关的死亡率； 3) 确定与化疗相关的长期或晚期毒性的发生率（例如心功能障碍、骨髓衰竭、第二恶性肿瘤和认知障碍）； 4) 确定住院治疗、死亡率和长期毒性如何随癌症类型以及化疗类型和剂量的变化而变化； 5) 研究住院治疗、死亡率和长期毒性如何随年龄、性别、种族、共病、社会经济因素、地理区域、医院和医生特征而变化。这些分析将在 1992 年至 2002 年间在 13 个 SEER 地区超过 300,000 名 65 岁或以上诊断患有上述癌症的患者中进行，其中超过 30% 的患者接受化疗。目前，尚无系统的方法来评估上市药物的长期毒性。拟议的对全国范围内基于人口的计算机化医疗保险索赔数据的创新使用为获取社区环境中上市后药物毒性信息提供了一种有前途且成本较低的方式。该数据库对于研究癌症化疗及其毒性特别独特，因为化疗是过去几十年医疗保险承保的少数药物之一。

项目成果

期刊论文数量（27）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Review of major adverse effects of androgen-deprivation therapy in men with prostate cancer.

前列腺癌男性雄激素剥夺疗法主要不良反应的回顾。

DOI：
发表时间：
2009-06-01
期刊：
影响因子：
6.2
作者：
Taylor, Lockwood G;Canfield, Steven E;Du, Xianglin L
通讯作者：
Du, Xianglin L

Racial disparities and survival for nonsmall-cell lung cancer in a large cohort of black and white elderly patients.

一大群黑人和白人老年患者中非小细胞肺癌的种族差异和生存率。

DOI：
发表时间：
2009-10-15
期刊：
影响因子：
6.2
作者：
Hardy, Dale;Xia, Rui;Liu, Chih;Cormier, Janice N;Nurgalieva, Zhannat;Du, Xianglin L
通讯作者：
Du, Xianglin L

Incidence trends of mantle cell lymphoma in the United States between 1992 and 2004.

1992 年至 2004 年间美国套细胞淋巴瘤的发病趋势。

DOI：
发表时间：
2008-08-15
期刊：
影响因子：
6.2
作者：
Zhou, Yuhong;Wang, Haijun;Fang, Wenjing;Romaguer, Jorge E;Zhang, Yanxia;Delasalle, Kay B;Kwak, Larry;Yi, Qing;Du, Xianglin L;Wang, Michael
通讯作者：
Wang, Michael

Comparative effectiveness of white blood cell growth factors on neutropenia, infection, and survival in older people with non-Hodgkin's lymphoma treated with chemotherapy.

白细胞生长因子对接受化疗的非霍奇金淋巴瘤老年人的中性粒细胞减少症、感染和生存的比较效果。