Postmarketing Surveillance of Toxicities Associated with Cancer Chemotherapy

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，化疗在延长患者生存期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，社区中很少有基于人群的癌症化疗相关毒性评估。我们对化疗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来评估与乳腺癌化疗相关的严重毒性的基于人群的住院治疗的可行性。 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化疗相关的几种主要癌症（包括乳腺癌，卵巢癌，结肠直肠癌和肺癌）的短期和长期毒性上市后监测的深入问题。我们的具体目标是：1）确定与化疗施用相关的短期毒性的住院率; 2）确定与化疗的短期毒性的住院相关的死亡率; 3）确定与化疗使用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、继发性恶性肿瘤和认知损害）; 4）确定住院、死亡率和长期毒性如何随癌症类型以及化疗的类型和量而变化;和5）检查住院、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、医院和医师特征而变化。 这些分析将在1992年至2002年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，尚无系统的方法评价上市药物的长期毒性。拟议创新使用全国范围内基于人口的计算机化医疗保险索赔数据，为在社区环境中获取上市后药物毒性信息提供了一种有前途且更便宜的方式。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来医疗保险覆盖的少数药物之一。

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.