Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Disease epidemiology

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine, other

Neulasta Onpro kit

Medical condition to be studied

Febrile neutropenia
Population studied

Short description of the study population

The study population will consist of subjects diagnosed with biopsy-proven confirmed breast cancer, lung cancer, NHL, or prostate cancer, who are receiving myelosuppressive chemotherapy and are at “high risk” for FN. Subjects at “high risk” for FN will be defined as subjects receiving high risk chemotherapy regimens with FN risk > 20%, or intermediate risk chemotherapy regimen with FN risk between 10% to 20% and 1 additional risk factor for FN.
Inclusion Criteria
1. Subject ≥ 18 years of age at the time of signing the informed consent form.
2. Subject with biopsy-proven breast cancer, lung cancer, NHL or prostate cancer starting myelosuppressive chemotherapy in the neoadjuvant/adjuvant or first line advanced/metastatic setting with at least 4 anticipated chemotherapy cycles.
3. Life expectancy > 6 months
4. Subject is starting or has recently (within the past 7 days) started myelosuppressive chemotherapy regimen with every 3 or 4-week cycle with a high FN risk > 20%, OR intermediate FN risk 10% to 20% risk (refer to Appendix E [only regimens listed within this appendix are allowed for enrollment]) and at least 1 risk factor for FN per Appendix F. Addition of non-cytotoxic targeted agents (eg, monoclonal antibodies, anti-angiogenic agents, and kinase inhibitors) to the listed chemotherapy regimens is permitted.
5. Subject who is starting adjuvant chemotherapy, neoadjuvant chemotherapy or first line chemotherapy in the metastatic setting and will be receiving at least 4 cycles of planned chemotherapy
Exclusion Criteria
1. Subject initiating chemotherapy regimen with < 14 days between cytotoxic and G-CSF drug dosing.
2. Planned chemotherapy dose reduction for cycle 1.
3. Known history of serious allergic reactions to pegfilgrastim or filgrastim.
4. Contraindication to short acting G-CSFs, Neulasta PFS, pegfilgrastim biosimilar PFS, or Neulasta Onpro kit.
5. Currently receiving treatment in another investigational device or drug study, or ≤ 28 days before screening/enrollment since ending treatment on another investigational device or drug study(ies).
6. Subject who started first line chemotherapy for metastatic disease who completed adjuvant/neoadjuvant chemotherapy < 6 months prior to study enrollment.
7. Subject who has received radiation < 2 weeks prior to study enrollment.
8. Any co-morbidity (refer to Appendix H) in the opinion of investigator will prevent the subject from receiving chemotherapy.
9. Subject has significant abnormalities on the most recent laboratory test prior to screening/enrollment per the Investigator including but not limited to the following: • white blood cell (WBC) < 4, ANC < lower limit of normal (LLN), hemoglobin < 10 g/dL, hematocrit < 30%, platelet count < 100,000, creatinine ≥ 1.5 or glomerular filtration rate < 30 (as calculated by Cockcroft-Gault Equation), total Bilirubin ≥ 2.0, aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≥ 3 x upper limit of normal (ULN), and a subject without liver metastasis or AST/ALT ≥ 5 ULN in a subject with liver metastasis
10. Known human immunodeficiency virus (HIV) infection by history.
11. History of solid organ or stem cell transplant.
12. Concurrent primary cancers except non-melanoma skin cancer, or adequately treated carcinoma in situ (CIS)

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Other

Special population of interest, other

Febrile neutropenia patients

Estimated number of subjects

5440
Study design details

Main study objective

To estimate the incidence of FN among subjects treated with myelosuppressive chemotherapy for the treatment of non myeloid malignancies and receiving Neulasta Onpro kit, Neulasta Onpro kit with every administered chemotherapy cycle, or other physician choice options for FN prophylaxis

Data analysis plan

Estimation Analysis, Confidence Intervals
Documents
Study results
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