Breast Cancer, Lung Cancer
Conditions
Keywords
recombinant human granulocyte colony-stimulating factors, G-CSFs, biosimilar, biologics, High Neutropenia Risk Chemotherapy, Biologic and Biosimilars Collective Intelligence Consortium, bbcic
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.
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.
Interventions
DRUGfilgrastim, TBO-filgrastim or pegfilgrastim
First cycle
Sponsors
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
Biologics & Biosimilars Collective Intelligence Consortium
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Incidence severe neutropenia | Anticipated completion February 2017 | Incidence severe neutropenia (ANC\<0.5g/l) |
Outcome results
None listed