ZOHé: A Prospective Study of the Use of Biosimilar Filgrastim Zarzio in Clinical Practice in Patients Treated With Chemotherapy for Lymphoid Malignancies.

Abstract

The ZOHé study was a prospective, observational, multicenter study in France to assess use of biosimilar filgrastim Zarzio in routine clinical practice in patients undergoing neutropenia-inducing chemotherapy. Patients≥ 18 years undergoing chemotherapy for a malignant disease and with a first prescription for Zarzio were enrolled in 2 cohorts: solid tumor (1174 patients) or hematological malignancy (633 patients); the latter is reported here. Analyses primarily described the prescription and use of Zarzio in current practice, and included identification of factors linked to prescription for primary prophylaxis, comparison of use in relation to European Organisation for the Research and Treatment of Cancer (EORTC) guidelines, and estimation of chemotherapy dose intensity maintenance in patients given Zarzio. Use of Zarzio in clinical practice was relatively standardized and followed label indication in 96.7% of the analysis population (633 patients). Most patients had≥ 2 EORTC patient-related risk factors for febrile neutropenia (FN). Chemotherapy dose intensity was maintained in 85.2% of evaluable patients and 89.6% of patients with non-Hodgkin lymphoma receiving R-CHOP (rituximab-cyclophosphamide/doxorubicin/vincristine/prednisone). The safety profile of Zarzio was confirmed. In routine clinical practice in France, Zarzio is mostly used as primary prophylaxis for chemotherapy-induced neutropenia in patients with hematological malignancies. Patient-related risk factors appear to have more weight in clinicians' decisions to give Zarzio than the FN risk category of the chemotherapy regimen alone in real-world practice.