COMPARATIVE EFFECTIVENESS OF BIOLOGIC AGENTS IN ETHNIC MINORITIES WITH COLORECTAL CANCER

生物制剂在少数民族结直肠癌中的比较疗效

• 批准号: 9432615
• 负责人: Sanjay Goel
• 金额: $ 21.58万
• 依托单位: MONTEFIORE MEDICAL CENTER (BRONX, NY)
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-06-01 至 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9432615
• 关键词: Adverse effects; Age; Age-Years; Aging; Applications Grants; Caucasians; Cetuximab; Clinical; Colorectal Cancer; County; Cytotoxic Chemotherapy; Data; Databases; Diagnosis; Elderly; Ethnic group; Expenditure; Felis catus; Future; Health Expenditures; Hispanics; Hospitals; Medicare; Minority; Pathogenesis; Patients; Pharmaceutical Preparations; Population; Race; Risk Factors; Suggestion; Survival Rate; Teenagers; Testing; Toxic effect; United States; base; bevacizumab; chemotherapy; cohort; comparative effectiveness; ethnic minority population; metastatic colorectal; panitumumab; young adult

Comparative effectiveness of biologic agents in ethnic minorities with colorectal cancer Abstract This grant proposal seeks to identify and describe the real world impact of the use of the biologic agents when added to cytotoxic chemotherapy for patients with metastatic colorectal cancer (mCRC). Furthermore, aging remains one the most critical risk factors in the pathogenesis of CRC . While CRC can occur in young adults and teenagers, more than 90% of CRC occur in people older than 50 years of age. The median age of diagnosis in the United States is 72 years. The biologic agents include bevacizumab, cetuximab and panitumumab. Cure rates for patients with mCRC are dismal, with a 5 year overall survival (OS) rate of only 12.5% and median OS of 30 months. The addition of biologic agents has led to statistically significant and clinically meaningful improvement in the OS; however little is known if the benefit it is uniformly shared across the various ethnic and racial groups. Over 70% of our patients are ethnic minorities. We conducted a CER study of our patients spanning 2000-2012. In our cohort of 290 patients, the median OS was 15.2 months in the patients that received chemotherapy versus 25.6 months in those that received chemotherapy plus biologics (p=0.0041 by log rank test). Propensity score based analysis overall and across the races showed a persistent benefit overall (HR 1.44; p=0.04), and this was maintained for Whites (HR 2.01, p=0.03) but not for Hispanics (HR 1.42, p=0.37) or Blacks (HR 1.12; p=0.59). We will first seek to validate our findings in the SEER Medicare database. Second, we seek to expand our cohort to include 3 hospitals in Bronx catering to ethnic minorities (Jacobi, Lincoln, and St. Barnabas hospitals). As Hispanics had a HR suggestive of benefit but did not reach statistical significance, with increased numbers available for analysis, we also aim to ascertain if this HR is statistically significant. If our findings are confirmed, this could indeed be practice changing, with the potential to save thousands of patients from the toxicity of these agents and billions of dollars to our ever soaring health care expenditure.

生物制剂治疗少数民族结直肠癌的疗效比较 摘要 这项拨款建议旨在确定和描述使用的真实的世界的影响， 转移性结直肠癌患者的细胞毒化疗中加入生物制剂 癌症（mCRC）。此外，老龄化仍然是最关键的风险因素之一， 大肠癌发病机制 .虽然CRC可以发生在年轻人和青少年中，但超过90%的人 CRC发生在50岁以上的人群中。在美国， 美国是72年。 生物制剂包括贝伐单抗、西妥昔单抗和帕尼单抗。 mCRC患者的治愈率令人沮丧，5年总生存率（OS）仅为 12.5%，中位OS为30个月。生物制剂的加入导致了统计学上的 OS显著且有临床意义的改善;然而， 它在各族裔和种族群体中是统一共享的。超过70%的患者 少数民族。我们对2000-2012年的患者进行了CER研究。在我们的队列中 在290例患者中，接受化疗的患者中位OS为15.2个月 而接受化疗加生物制剂的患者为25.6个月（对数秩检验，p=0.0041 test）。基于倾向评分的分析显示，总体和跨种族的持续受益 总体（HR 1.44; p=0.04），白人保持不变（HR 2.01，p=0.03），但 西班牙裔（HR 1.42，p=0.37）或黑人（HR 1.12; p=0.59）。我们将首先寻求验证我们的 SEER Medicare数据库中的结果。第二，我们寻求扩大我们的队列，包括3 布朗克斯的少数民族医院（雅可比、林肯和圣巴纳巴斯医院）。作为 西班牙裔患者的HR提示获益，但未达到统计学显著性， 增加可用于分析的数量，我们还旨在确定这一HR是否在统计学上 显著如果我们的发现得到证实，这可能确实是实践的改变， 有可能挽救成千上万的患者免受这些药物的毒性，并节省数十亿美元， 我们不断飙升的医疗保健开支。