ZOHé: A prospective study of the use of biosimilar filgrastim Zarzio® in clinical practice in patients treated with chemotherapy for lymphoid malignancies

• Published in: Clinical lymphoma, myeloma and leukemia Vol. 17; no. 6; pp. 362 - 369.e2
• Main Authors: Damaj, Gandhi Laurent, Benbrahim, Omar, Hacini, Maya, Voronina, Inna, Benabed, Khaled, Soumoudronga, Ravaka-Fatoma, Gasnereau, Isabelle, Haioun, Corinne, Solal-Céligny, Philippe
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2017
• Subjects: Aged; EP2006; Febrile neutropenia; Female; Filgrastim - pharmacology; Filgrastim - therapeutic use; G-CSF; Hematologic Agents - pharmacology; Hematologic Agents - therapeutic use; Hematology, Oncology and Palliative Medicine; Humans; Lymphoma, B-Cell - drug therapy; Lymphoma, B-Cell - pathology; Male; Middle Aged; Prophylaxis; Prospective Studies; Real-world practice; EP2006; febrile neutropenia; real-world practice; G-CSF; prophylaxis; Real-world practice; Prophylaxis; Febrile neutropenia
• ISSN: 2152-2650; 2152-2669
• DOI: 10.1016/j.clml.2017.05.002

Abstract Background The ZOHé study was a prospective, observational, multicentre study in France to assess use of biosimilar filgrastim Zarzio® in routine clinical practice in patients undergoing neutropenia-inducing chemotherapy (CT). Patients and methods Patients ≥18 years undergoing CT for a malignant disease and with a first prescription for Zarzio® were enrolled in two cohorts: solid tumour (1174 patients) or haematological 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 CT dose intensity maintenance in patients given Zarzio®. Results Use of Zarzio® in clinical practice was relatively standardised and followed label indication in 96.7% of the analysis population (633 patients). The majority of patients had ≥2 EORTC patient-related risk factors for febrile neutropenia (FN). CT 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. Conclusions In routine clinical practice in France, Zarzio® is mostly used as primary prophylaxis for CT-induced neutropenia in patients with haematological malignancies. Patient-related risk factors appear to have more weight in clinicians’ decisions to give Zarzio® than the FN risk category of the CT regimen alone in real-world practice.