Gandhi Laurent Damaj1, Omar Benbrahim2, Maya Hacini3, Inna Voronina4, Khaled Benabed5, Ravaka-Fatoma Soumoudronga6, Isabelle Gasnereau6, Corinne Haioun7, Philippe Solal-Céligny8. 1. Institut d'hématologie, Centre Hospitalier Universitaire de Caen and Faculté de Médecine, Université de Caen-Normandie, Caen, France. 2. Centre Hospitalier Régionale d'Orléans, Orléans, France. 3. Centre Hospitalier Métropole Savoie, Chambéry, France. 4. Centre Hospitalier Boulogne, Boulogne-sur-Mer, France. 5. Centre Hospitalier Public du Cotentin, Cherbourg-en-Cotentin and Centre Hospitalier Universitaire Côte de Nacre, Caen, France. 6. Sandoz France, Levallois-Perret, France. 7. Unité Hémopathies Lymphoïdes, Hôpital Henri Mondor-Albert, Université Paris Est, Créteil, France. 8. Institut de Cancérologie de l'Ouest René Gauducheau, Saint Herblain, France. Electronic address: philippe.solal-celigny@ico.unicancer.fr.
Abstract
BACKGROUND: 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 AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
BACKGROUND: 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 AND METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.