Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

An Exploratory Comparative Effectiveness Analysis of Granulocyte Colony Stimulating Factor Originator Products Versus Biosimilars in Real-world Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04971304
• Other study ID #: BBCIC-GCSF-02
• Status: Completed
• Start date: March 1, 2015
• Est. completion date: December 31, 2022

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

This comparative effectiveness and descriptive retrospective cohort study will evaluate safety and effectiveness outcomes among commercially insured adults who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy.

Description:

This comparative effectiveness and descriptive retrospective cohort study includes commercially insured adults enrolled in one of four health plans participating in the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network. The investigators included patients who received a granulocyte colony stimulating factor (G-CSF) biosimilar or originator product during the first cycle of clinical guideline-indicated intermediate or high febrile neutropenia risk chemotherapy. The investigators will collect patient demographics, cancer diagnosis, chemotherapy regimen, and patterns of G-CSF biosimilar and originator product use. The investigators will follow patients from first G-CSF exposure until up to six cycles of chemotherapy receipt, death, or insurance disenrollment. The primary effectiveness outcome is incidence of febrile neutropenia. Secondary outcomes include incidence of adverse events and trends in product use over time. The investigators will compare febrile neutropenia incidence between originator and biosimilar products using inverse probability weighting to control for confounding. Secondary analyses will examine 'as treated' outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16506
• Est. completion date: December 31, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients age 20 or older
• Diagnosis of lung, breast, colon, ovarian, pancreatic, testicular, cervical, uterine, or NHL cancer
• Beginning intermediate or high neutropenia risk chemotherapy

Exclusion Criteria:

• One inpatient or two outpatient cancer diagnoses at least 30 days apart in the 183 days prior to the Index Date for cancer different from enrolling cancer diagnosis
• Any of the following in 183 days prior to Index Date:
• Any chemotherapy or G-CSF product receipt
• 2< medical claims at least 30 days apart for a skilled nursing facility or hospice care
• 2< diagnoses/procedure codes at least 1 day apart for cancer-related radiotherapy, bone marrow or stem cell transplant, diagnosis of HIV/AIDS, severe hepatic disease, chronic kidney disease, or any non-oncology related neutropenia

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer of Colon
• Cancer of Pancreas
• Cancer, Breast
• Cancer, Lung
• Cancer, Ovarian
• Colonic Neoplasms
• Lung Neoplasms
• Lymphoma, Non-Hodgkin
• Ovarian Neoplasms
• Pancreatic Neoplasms

Intervention

Drug:
• Receipt of granulocyte-colony stimulating factor
Receipt of originator or biosimilar

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Catherine M. Lockhart	Harvard Pilgrim Health Care, HealthPartners Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who develop febrile neutropenia	ICD-9 or ICD-10 codes for inpatient or outpatient visit indicating fever with infection per validated algorithms.	Within 30 days of receipt of first chemotherapy
Secondary	Number of patients who develop G-CSF associated adverse events	ICD-9 or ICD-10 codes indicating splenic rupture, anaphylaxis, or leukocytosis.	Within 30 days of receipt of first chemotherapy