International, Prospective, Open-label, Multicenter, Pharmacoepidemiological Study to Determine Predictors of Clinical Outcomes in Chemotherapy-treated Cancer Patients at Risk for Febrile Neutropenia and Treated Prophylactically With Filgrastim Biosimilar.
- Male or female adults (age > / = 18 years)
- Diagnosed with one of the following types and stages of tumors: stage III or IV
breast cancer; stage III or IV ovarian cancer; stage III or IV bladder cancer; stage
III or IV lung cancer; metastatic prostate cancer; stage III or IV diffuse large
B-cell lymphoma; multiple myeloma.
- Planned to receive primary prophylaxis with ZARZIO® at the first cycle of
chemotherapy (regardless of line of chemotherapy); or receiving secondary prophylaxis
with ZARZIO® irrespective of chemotherapy cycle.
- Treated with commercially available ZARZIO® per physician's best clinical judgment
and per current European ZARZIO® label.
- Female patients must be either post-menopausal for one year or surgically sterile or
using effective contraceptive methods such as barrier method with spermicide or an
intra-uterine device. Oral contraceptive use is allowed.
- Informed written consent to participate in the study by patients or their legal
- Patients with myeloid malignancies, with the exception of multiple myeloma.
- Sensitivity to ZARZIO® or any other CSF.
- Hypersensitivity to E. coli-derived proteins.
- Radiotherapy to ≥ 20% of total body bone.
- Infection within two weeks of starting current line of chemotherapy.
- Patients with several medical condition(s) that in view of the investigator prohibits
participation in the study.
- Patients with willfully negligent nonadherence to their cancer treatment.
- Use of any investigational agent in the 30 days prior to enrollment.
- Women of childbearing potential not using the contraception method(s) described
- Women who are breastfeeding.