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

Sandoz

Status: Completed

Conditions: Breast Cancer; Febrile Neutropenia; Bladder Cancer; Multiple Myeloma; B-cell Lymphoma; Lung Cancer; Cancer; Ovarian Cancer; Prostate Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT01459653

EP06-502

Details and patient eligibility

About

This international, prospective, observational, open-label, pharmaco-epidemiologic study observes cancer patients at risk for chemotherapy-induced febrile neutropenia (FN) who are receiving filgrastim biosimilar (EP2006) for primary or secondary FN prophylaxis to better describe the patient population at risk for FN and treated prophylactically in physician's best clinical judgement with filgrastim biosimilar (EP2006), to describe prophylaxis patterns involving filgrastim biosimilar (EP2006), and to evaluate hematology levels and variability in hematological outcomes, impact on chemotherapy delivery, radiotherapy, surgery, and mortality. Additionally the study aims to identify patient cohorts who are vulnerable to poor response to FN prophylaxis and experience break-through episodes of FN, understand the differences between prophylaxis responders and non-responders, and describe the degree to which prophylaxis of FN is in congruence with guideline recommendations.

Enrollment: 1,496 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 filgrastim biosimilar (EP2006) at the first cycle of chemotherapy (regardless of line of chemotherapy); or receiving secondary prophylaxis with filgrastim biosimilar (EP2006) irrespective of chemotherapy cycle.
• Treated with commercially available filgrastim biosimilar per physician's best clinical judgment and per current European filgrastim biosimilar (EP2006) 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 filgrastim biosimilar 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.

Trial design

1,496 participants in 1 patient group

Only 1 group

Description:

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