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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921191
• Other study ID #: BBCIC -GCFs
• Status: Completed
• Start date: January 2008
• Est. completion date: February 2019

Study information

• Verified date: July 2023
• Source: Biologics & Biosimilars Collective Intelligence Consortium
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57725
• Est. completion date: February 2019
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• filgrastim, TBO-filgrastim or pegfilgrastim
First cycle

Locations

Country	Name	City	State
n/a

Sponsors (9)

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

References & Publications (2)

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. doi: 10.18553/jmcp.2015.21.1.23. — View Citation

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:jnccn20268. doi: 10.6004/jnccn.2021.7027. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalizations for severe neutropenia	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	Incidence severe neutropenia	Incidence severe neutropenia (ANC<0.5g/l)	Anticipated completion February 2017

External Links

•   The Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) was established in 2015 to address anticipated needs for post-marketed evidence generation for novel biologics, their corresponding biosimilars and other related products.