Use of Biosimilar Nivestim® to Prevent Chemo-induced Neutropenia. Real Life Study (VISTA)

Pfizer

Status: Terminated

Conditions: Chemotherapy-Induced Neutropenia

Treatments: Biological: Nivestim®

Study type: Observational

Funder types: Industry

Identifiers

NCT02454530

C1121007 (Other Identifier)

VISTA

Details and patient eligibility

About

The aim of this study is to describe in real-life conditions the determinants of use of GCSF (Granulocyte Colony-Stimulating Factor) Nivestim® in primary or secondary prophylaxis and in patients receiving chemotherapy for solid tumour according to the chemotherapy context: adjuvant or metastatic setting.

Full description

This is a longitudinal, observational, prospective, multicentre, cohort study, conducted in France among a representative sample of public and/or private hospital-based oncologists.

Data will be collected by the investigator during three visits using data available in the patient medical record and obtained from patient questioning and clinical examination performed during the consultations:

• Baseline visit: prescription of Nivestim®.
• Follow-up visit: during the first cycle of chemotherapy after the first course of Nivestim®.
• Final visit: after the last cycle of chemotherapy or 16-18 weeks after inclusion.

Enrollment: 1,160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged at least 18 years, seen by the oncologist for chemotherapy for solid tumour.
• Patients for whom the oncologist has decided the initiation of G-CSF biosimilar treatment (Nivestim®) in primary or secondary prophylaxis.
• Patients informed about the computer processing of their medical data and their right of access and correction.

Exclusion criteria

• Patients with contraindication of use of Nivestim®.
• Patients with haematological malignancy including Myelodysplasia and Chronic myeloid leukemia treated or untreated.
• Patients participating or having participated in the previous month in a clinical trial.
• Patients refusing to participate in this study.

Trial design

1,160 participants in 1 patient group

Cancer patients treated with Nivestim®

Treatment:

Biological: Nivestim®