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

NCT02921191 | Completed DMC

• 1 other identifier: BBCIC -GCFs
• Study Type: observational
• Target: 57,725
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Lung Cancer

Keywords

recombinant human granulocyte colony-stimulating factors; G-CSFs; biosimilar; biologics; High Neutropenia Risk Chemotherapy; Biologic and Biosimilars Collective Intelligence Consortium; bbcic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Incidence severe neutropenia

  Anticipated completion February 2017

Study Arms (2)

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

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

Interventions

filgrastim, TBO-filgrastim or pegfilgrastim DRUG

First cycle

Also known as: Neupogen, Neulasta, Granix, Zarxio

Breast cancer; Lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Related 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.

  PMID: 25562770 BACKGROUND

• 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.

  PMID: 34399406 BACKGROUND

Related 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.

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms

Interventions

Filgrastim; pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Vanita Pindolia, PharmD, VP

  Henry Ford Health Systems

  PRINCIPAL INVESTIGATOR

• Pam Pawloski, PharmD

  HealthPartners Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 3, 2016
• Study Start: January 1, 2008
• Primary Completion: September 1, 2015
• Study Completion: February 1, 2019
• Last Updated: July 27, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• 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."