Descriptive Analysis of G-CSF Use in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated
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 |
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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
Arms and Interventions
Arm | Intervention/Treatment |
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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:
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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:
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Outcome Measures
Primary Outcome Measures
- 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
- Incidence severe neutropenia [Anticipated completion February 2017]
Incidence severe neutropenia (ANC<0.5g/l)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Individuals with baseline period of 183 days with continuous medical and pharmacy coverage preceding the first prescription fill for G-CSF
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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)
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Chemotherapy drug.
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Skilled nursing facility (SNF) or hospice care
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Diagnosis for a secondary breast cancer diagnosis
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A second cancer diagnosis (i.e., not breast, lung, lymphoma)
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Bone marrow or stem cell transplant
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Radiotherapy
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Chemo cycle >First: (exclude any chemotherapy cycles post the index G-CSF date)
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HIV/AIDS
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Hepatic disease
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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
- AMCP Task Force on Biosimilar Collective Intelligence Systems, Baldziki M, Brown J, Chan H, Cheetham TC, Conn T, Daniel GW, Hendrickson M, Hilbrich L, Johnson A, Miller SB, Moore T, Motheral B, Priddy SA, Raebel MA, Randhawa G, Surratt P, Walraven C, White TJ, Bruns K, Carden MJ, Dragovich C, Eichelberger B, Rosato E, Sega T. Utilizing data consortia to monitor safety and effectiveness of biosimilars and their innovator products. J Manag Care Spec Pharm. 2015 Jan;21(1):23-34.
- Pawloski PA, McDermott CL, Marshall JH, Pindolia V, Lockhart CM, Panozzo CA, Brown JS, Eichelberger B. BBCIC Research Network Analysis of First-Cycle Prophylactic G-CSF Use in Patients Treated With High-Neutropenia Risk Chemotherapy. J Natl Compr Canc Netw. 2021 Aug 16. pii: jnccn20268. doi: 10.6004/jnccn.2021.7027. [Epub ahead of print]
- BBCIC -GCFs