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

Study Overview
=================
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.

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

Conditions
-----------------
Breast Cancer, Lung Cancer

Intervention / Treatment
-----------------
* Drug: filgrastim, TBO-filgrastim or pegfilgrastim


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lung cancer<br>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<br>* First cycle<br>* Other names: Neupogen, Neulasta, Granix, Zarxio;|
| Breast cancer<br>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<br>* First cycle<br>* Other names: Neupogen, Neulasta, Granix, Zarxio;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence severe neutropenia | Incidence severe neutropenia (ANC<0.5g/l) | Anticipated completion February 2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
recombinant human granulocyte colony-stimulating factors, G-CSFs, biosimilar, biologics, High Neutropenia Risk Chemotherapy, Biologic and Biosimilars Collective Intelligence Consortium, bbcic