Multi-level Evaluation of Chemotherapy-induced Febrile Neutropenia Prophylaxis, Outcomes, and Determinants With Granulocyte-colony Stimulating Factor (Monitor-GCSF)

• Cohort identification and differentiation [ Time Frame: 6 months, 6 cycles of chemotherapy ] [ Designated as safety issue: No ]
  Patient profiles based on medical history, concomitant comorbid conditions and current clinical status.
• Nonresponder analyses [ Time Frame: 6 months, 6 cycles of chemotherapy ] [ Designated as safety issue: Yes ]

  Patient- and center-level variables between patients who had:

  • chemotherapy dose delays or reductions,
  • surgery delays or cancellations, and
  • radiotherapy delays, dose reductions or cancellations vs no such events and
  • patients who died vs. survived during the course of prophylaxis with filgrastim biosimilar in all patients and those with break-through FN episodes.

This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for febrile neutropenia (FN) who are receiving filgrastim biosimilar for primary or secondary FN prophylaxis to better describe the patient population at risk for FN, to describe prophylaxis patterns involving filgrastim biosimilar, and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy and surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which therapy and prophylaxis of FN is in congruence with guideline recommendations.

Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for febrile neutropenia.

• Febrile Neutropenia
• Cancer
• Breast Cancer
• Ovarian Cancer
• Lung Cancer
• Prostate Cancer
• Multiple Myeloma
• Bladder Cancer
• B-cell Lymphoma

Inclusion Criteria:

• 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 guardian.

Exclusion Criteria:

• 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 above.
• Women who are breastfeeding.