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

July 25, 2023 updated by: Biologics & Biosimilars Collective Intelligence Consortium

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

57725

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study subjects are selected according to inclusion criteria from a source population within the Sentinel Common Data Mode v5.0.1 (SCDM). The SCDM includes over 100 million individuals with 358 million person-years of observation time who are covered by Aetna, Anthem, Group Health Cooperative, Harvard Pilgrim Health Care, and HealthPartners. The time period assessed will be 1/1/2008-9/30/2015.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospitalizations for severe neutropenia
Time Frame: 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
Anticipated completion February 2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence severe neutropenia
Time Frame: Anticipated completion February 2017
Incidence severe neutropenia (ANC<0.5g/l)
Anticipated completion February 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biologics & Biosimilars Collective Intelligence Consortium

Collaborators

Henry Ford Health System
HealthPartners Institute
Amgen
Aetna, Inc.
Harvard Pilgrim Health Care
Momenta Pharmaceuticals, Inc.
College of Pharmacy, University of Nebraska College
College of Pharmacy, University of New England

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

February 1, 2019

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

September 29, 2016

First Posted (Estimated)

October 3, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BBCIC -GCFs

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BBCIC Charter requires transparency and publication

IPD Sharing Time Frame

Publication is in press as of January 2021 in the Journal of the National Comprehensive Cancer Network. Pawlowski PM, McDermott CL, Marshall JH et al.

"BBCIC Research Network Analysis of First-Cycle Prophylactic G-CSF Use in Patients Treated With High Neutropenia Risk Chemotherapy."

IPD Sharing Supporting Information Type

  • SAP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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