Clinical trial NCT02921191: Descriptive Analysis of G-CSF Use in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Biologics & Biosimilars Collective Intelligence Consortium
Sponsor class: OTHER
Collaborators: name: Henry Ford Health System
name: Aetna, Inc.
name: Amgen
name: College of Pharmacy, University of Nebraska College
name: College of Pharmacy, University of New England
name: HealthPartners Institute
name: Momenta Pharmaceuticals, Inc.
name: Harvard Pilgrim Health Care
First posted: 2016-10-03
Enrollment: 57725
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospitalizations for severe neutropenia
timeFrame: Anticipated completion February 2017
Secondary outcomes:
measure: Incidence severe neutropenia
timeFrame: Anticipated completion February 2017
Other outcomes:
Locations:
Study officials:
affiliation: Henry Ford Health Systems
name: Vanita Pindolia, PharmD, VP
role: PRINCIPAL_INVESTIGATOR
affiliation: HealthPartners Institute
name: Pam Pawloski, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.