Caspofungin or Micafungin as Empiric Antifungal Therapy for Persistent Fever and Neutropenia

• Composite Primary Endpoint: Number of Participants With an Overall Favorable Response to Echinocandin Therapy for Empiric Antifungal Therapy for Persistent Febrile Neutropenia (FN) [ Time Frame: 11/1/2005 - 10/31/2007 ] [ Designated as safety issue: No ]
  Overall favorable response was defined as achievement of successful treatment of baseline fungal infections, survival to hospital discharge, absence of breakthrough Ivasive fungal disese (IFD), and lack of advserse events (AE) attributable to treatment that led to discontinuation of echinocandin therapy.
  
  
• Successful Treatment of Any Baseline Invasive Fungal Disease (IFD) [ Time Frame: 11/1/2005 - 10/31/2007 ] [ Designated as safety issue: No ]
  Possible or proven baseline invasive fungal disease were defined as were diagnosed within the 2 days of initiating echinocandin therapy for persistent febrile neutropenia
  
  
• Mortality at Hospital Discharge [ Time Frame: 11/1/2005 - 10/31/2007 ] [ Designated as safety issue: No ]
  We assessed all patients in the study cohort who dischaged from the hospital alive
  
  
• Absence of Any Breakthrough Invasive Fungal Disease (IFD) [ Time Frame: 11/1/2005 - 10/31/2007 ] [ Designated as safety issue: No ]
  a breakthrough invasive fungal disesase was defined as any fungal infection that was diagnosed > 3 days on or during therapy or within 7 days after completion of therapy with an echinocandin
  
  
• Lack of an Adverse Drug Event (ADE) Attributable to Echinocandin (EC) Therapy That Led to Discontinuation of Therapy [ Time Frame: 11/1/2005 - 10/31/2007 ] [ Designated as safety issue: No ]
  Defined as any advsere event directly attributable to echinocandin treatment that led to discontinuation of therapy or switch to alternative therapy
  
  

• Duration of Echinocadin Therapy for Persistent Febrile Neutropenia (FN) [ Time Frame: 11/1/2005 - 10/31/2007 ] [ Designated as safety issue: No ]
  median duration of therapy with an echinocandin (caspofungin or micafungin) for persistent febrile neutropenia (FN)
  
  
• Liver Function Tests (LFTs) Elevated During or After Echinocandin Therapy [ Time Frame: 11/1/2005 - 10/31/2007 ] [ Designated as safety issue: No ]
  aspartate aminotransferase (AST) or alanine aminotransferase (ALT)> 5x the upper limit of normal (ULN) or total bilirubin > 3x the upper limit of normal (ULN)
  
  
• Specific Type of Adverse Event That Resulted in Echinocandin (EC) Therapy Discontinuation [ Time Frame: 11/1/2005 - 10/31/2007 ] [ Designated as safety issue: Yes ]
  The description of the adverse event that resulted in discontinuation of echinocandin (EC) therapy
  
  
• Duration of Hospitization [ Time Frame: 11/1/2005 - 10/31/2007 ] [ Designated as safety issue: No ]
  Median number of days patients were hospitalized during the study period
  
  
• Duration of Neutropenia [ Time Frame: 11/1/2005 - 10/31/2007 ] [ Designated as safety issue: No ]
  Median number of days patients were neutropenic during the study period
  
  

Objectives

This retrospective cohort analysis of converting from caspofungin to micafungin as empiric antifungal therapy for cancer patients who are persistently febrile and neutropenic after receiving broad spectrum antibiotics at Brigham & Women's Hospital / Dana Farber Cancer Institute (BWH/DFCI) is designed to evaluate the following objectives:

• Safety of micafungin in this patient population
• Effective dose of 100 mg daily of micafungin compared to 70mg x1, then 50 mg daily of caspofungin
• Economic impact of converting or formulary echinocandin from micafungin to caspofungin

Study Design

• Retrospective cohort analysis - limited to medical records

• Data to be collected include the following:

  • Demographic information: including: gender, age, race
  • Past medical history and admitting diagnoses
  • Laboratory results: Liver function tests (LFTs), Including alanine aminotransferase (ALT), aspartate aminotransferase (AST), Total bilirubin, as well as serum fungal assays: Serum Galactomannan assay, 1.3-BD Glucan assay
  • Concomitant medications and duration of therapy for all systemic: antibiotics and antifungals
  • All invasive breakthrough fungal infection details, including speciation and outcomes during echinocandin therapy
  • Dosing, duration, and adverse events associated with echinocandin therapy