Descriptive Analysis of G-CSF Use in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated

Sponsor
Biologics & Biosimilars Collective Intelligence Consortium (Other)
Overall Status
Completed
CT.gov ID
NCT02921191
Collaborator
Henry Ford Health System (Other), Aetna, Inc. (Industry), Amgen (Industry), College of Pharmacy, University of Nebraska College (Other), College of Pharmacy, University of New England (Other), HealthPartners Institute (Other), Momenta Pharmaceuticals, Inc. (Industry), Harvard Pilgrim Health Care (Other)
57,725
133

Study Details

Study Description

Brief Summary

Purpose:

With the existing recombinant human granulocyte colony-stimulating factors (G-CSFs) patents expiring and the FDA approval of new biosimilar and innovator biologics, patients being treated with Grade III and IV myelosuppressive chemotherapy regimens will have additional therapeutic options. This observational study will describe the patient characteristics of new users of G-CSFs. It will describe in the treatment cohorts a primary outcome of hospitalizations for febrile neutropenia. The BBCIC will use the findings from this descriptive analysis to design a comparative study evaluating the real-world effectiveness and safety of biosimilar and innovator G-CSFs.

Condition or Disease Intervention/Treatment Phase
  • Drug: filgrastim, TBO-filgrastim or pegfilgrastim

Detailed Description

Additional information:

To most effectively interpret results from this descriptive analysis it is important to consider that this protocol was not designed to support a hypothesis. This information is being provided to the public in the interest of transparency and for demonstrating the BBCIC's Distributed Research Network's (DRN) ability to define exposures, outcomes, covariates and confounders. When published, the report will caution that the protocol does not support any ability to compare safety or effectiveness but instead is to be used only to explore the feasibility of future, more detailed comparative analyses and to better understand the capabilities of the BBCIC project. Further, the report will caution that information from this protocol should not affect use of the medical products described in any way and the fact that the BBCIC is performing this descriptive analysis in no way suggests there is a safety or effectiveness issue with any of the products described.

Study Design

Study Type:
Observational
Actual Enrollment :
57725 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Descriptive Analysis of First-Cycle Prophylactic Use of G-CSF in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated With High Neutropenia Risk Chemotherapy
Study Start Date :
Jan 1, 2008
Actual Primary Completion Date :
Sep 1, 2015
Actual Study Completion Date :
Feb 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Lung cancer

Lung cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF.

Drug: filgrastim, TBO-filgrastim or pegfilgrastim
First cycle
Other Names:
  • Neupogen, Neulasta, Granix, Zarxio
  • Breast cancer

    Breast cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF (filgrastim, TBO-filgrastim or pegfilgrastim)

    Drug: filgrastim, TBO-filgrastim or pegfilgrastim
    First cycle
    Other Names:
  • Neupogen, Neulasta, Granix, Zarxio
  • Outcome Measures

    Primary Outcome Measures

    1. Hospitalizations for severe neutropenia [Anticipated completion February 2017]

      Primary: Incidence of hospitalizations for febrile neutropenia in patients with breast or lung cancer receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF

    Secondary Outcome Measures

    1. Incidence severe neutropenia [Anticipated completion February 2017]

      Incidence severe neutropenia (ANC<0.5g/l)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Individuals with baseline period of 183 days with continuous medical and pharmacy coverage preceding the first prescription fill for G-CSF

    • Breast or lung cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF.

    Exclusion Criteria:

    During baseline 365 days, any patient with a claim for (or with)

    • Chemotherapy drug.

    • Skilled nursing facility (SNF) or hospice care

    • Diagnosis for a secondary breast cancer diagnosis

    • A second cancer diagnosis (i.e., not breast, lung, lymphoma)

    • Bone marrow or stem cell transplant

    • Radiotherapy

    • Chemo cycle >First: (exclude any chemotherapy cycles post the index G-CSF date)

    • HIV/AIDS

    • Hepatic disease

    • Other non-oncology related neutropenia

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Biologics & Biosimilars Collective Intelligence Consortium
    • Henry Ford Health System
    • Aetna, Inc.
    • Amgen
    • College of Pharmacy, University of Nebraska College
    • College of Pharmacy, University of New England
    • HealthPartners Institute
    • Momenta Pharmaceuticals, Inc.
    • Harvard Pilgrim Health Care

    Investigators

    • Principal Investigator: Vanita Pindolia, PharmD, VP, Henry Ford Health Systems
    • Principal Investigator: Pam Pawloski, PharmD, HealthPartners Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Biologics & Biosimilars Collective Intelligence Consortium
    ClinicalTrials.gov Identifier:
    NCT02921191
    Other Study ID Numbers:
    • BBCIC -GCFs
    First Posted:
    Oct 3, 2016
    Last Update Posted:
    Jul 30, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Biologics & Biosimilars Collective Intelligence Consortium
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 30, 2021