Postmarketing Surveillance of Toxicities Associated with Cancer Chemotherapy

描述(申请人提供)：描述(申请人提供)：对于越来越多的癌症，化疗在延长患者生存和减少肿瘤复发方面是有效的。几乎所有的化疗药物都与毒性有关，这是限制其使用的主要因素。目前关于不同类型化疗毒性的信息通常来自随机对照试验。然而，在社区中，很少有基于人群的与癌症化疗相关的毒性评估。我们对化疗的医疗保险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关于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评估因乳腺癌化疗相关的严重毒性而以人群为基础的住院治疗的可行性。 我们建议使用最新的国家癌症研究所的SEER(监测、流行病学和最终结果)-Medicare关联数据来解决有关几种主要癌症(包括乳腺癌、卵巢癌、结直肠癌和肺癌)的化疗相关短期和长期毒性的上市后监测的深入问题。我们的具体目标是：1)确定与化疗相关的短期毒性的住院率；2)确定因化疗的短期毒性而住院的死亡率；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、继发性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、化疗的类型和数量而变化；以及5)检查住院、死亡率和长期毒性如何随年龄、性别、种族、合并症、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年期间在13个SEER地区的30多万名年龄在65岁或以上的被诊断患有上述癌症的大型人群队列中进行，其中30%以上接受了化疗。目前，还没有一种系统的方法来评估上市药物的长期毒性。拟议的创新使用全国性的、基于人口的计算机化的医疗保险索赔数据，为在社区环境中获得上市后药物毒性信息提供了一种有前途的、成本更低的方式。这个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来医疗保险覆盖的为数不多的药物之一。

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.