Clinical trial · Observational
Descriptive Analysis of G-CSF Use in Patients With Breast Cancer, Lung Cancer, or Lymphoma Treated
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| filgrastim, TBO-filgrastim or pegfilgrastim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Lung cancer
- description
- Lung cancer patients receiving their first cycle of Grade III and IV myelosuppressive chemotherapy regimen treated prophylactically with G-CSF.
- interventionNames
- Drug: filgrastim, TBO-filgrastim or pegfilgrastim
- label
- Breast cancer
- description
- 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)
- interventionNames
- Drug: filgrastim, TBO-filgrastim or pegfilgrastim
Primary outcomes (1)
- measure
- Hospitalizations for severe neutropenia
- timeFrame
- Anticipated completion February 2017
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDAMCP 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
- BACKGROUNDPawloski 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