A Prospective Observational Study of Neutropenia and Anemia Management in Subjects With Solid Tumors Receiving Myelotoxic Chemotherapy
This is a multi center international observational study of subjects receiving myelotoxic
regimens, with an investigator assessed risk of FN ≥ 20%, for the treatment of solid tumors
(breast, ovarian and lung). Approximately 100-150 sites will contribute information on
10-15 subjects treated at their institution. Sites will be selected where the data specified
below is routinely collected for patient management. The selection of sites will be managed
to try and represent a selection of various treating centers within each country. However,
whilst sites will be encouraged to provide data on patients with all tumor types this will
not be enforced and sites or indeed countries may enroll patients to only 1 tumor group.
The reason for any site not wishing to participate will be recorded and reported at study
end. Approximately 1300 subjects will be recruited . The aim is to have approximately 800
breast cancer, 300 Non-Small Cell Lung Cancer, 100 Small-Cell Lung Cancer and 100 ovarian
Time Perspective: Prospective
To describe incidence of Febrile Neutropenia (FN) based on Granulocyte Colony Stimulating Factor (G-CSF) (primary, secondary or no usage) use in subjects receiving myelotoxic chemotherapy.
The duration of the G-CSF use
Australia: Human Research Ethics Committee