COMPARATIVE EFFECTIVENESS OF BIOLOGIC AGENTS IN ETHNIC MINORITIES WITH COLORECTAL CANCER

Information

  • Research Project
  • 9432615
  • ApplicationId
    9432615
  • Core Project Number
    R21AG058027
  • Full Project Number
    1R21AG058027-01
  • Serial Number
    058027
  • FOA Number
    PA-16-161
  • Sub Project Id
  • Project Start Date
    6/1/2018 - 6 years ago
  • Project End Date
    5/31/2020 - 4 years ago
  • Program Officer Name
    SALIVE, MARCEL
  • Budget Start Date
    6/1/2018 - 6 years ago
  • Budget End Date
    5/31/2019 - 5 years ago
  • Fiscal Year
    2018
  • Support Year
    01
  • Suffix
  • Award Notice Date
    5/31/2018 - 6 years ago

COMPARATIVE EFFECTIVENESS OF BIOLOGIC AGENTS IN ETHNIC MINORITIES WITH COLORECTAL CANCER

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.

IC Name
NATIONAL INSTITUTE ON AGING
  • Activity
    R21
  • Administering IC
    AG
  • Application Type
    1
  • Direct Cost Amount
    150000
  • Indirect Cost Amount
    65786
  • Total Cost
    215786
  • Sub Project Total Cost
  • ARRA Funded
    False
  • CFDA Code
    866
  • Ed Inst. Type
  • Funding ICs
    NIA:215786\
  • Funding Mechanism
    Non-SBIR/STTR RPGs
  • Study Section
    NRCS
  • Study Section Name
    Nursing and Related Clinical Sciences Study Section
  • Organization Name
    MONTEFIORE MEDICAL CENTER (BRONX, NY)
  • Organization Department
  • Organization DUNS
    041581026
  • Organization City
    NEW YORK
  • Organization State
    NY
  • Organization Country
    UNITED STATES
  • Organization Zip Code
    104672490
  • Organization District
    UNITED STATES