1555P - Biosimilar Filgrastim Initiation in Patients Enrolled in the Monitor G-CSF Observational Study Relative to EORTC Guidelines

Abstract

ABSTRACT Introduction MONITOR G-CSF is a prospective observational study of practice patterns and outcomes for prophylaxis of chemotherapy-induced febrile neutropenia (FN) with biosimilar filgrastim (Zarzio®, Sandoz Biopharmaceuticals). Methods This analysis describes treatment initiation with biosimilar filgrastim in the 788 patients enrolled to date (target 1500) in the MONITOR G-CSF study relative to the 2010 EORTC G-CSF guidelines. Patients were enrolled at 134 centres (199 open) across 12 European countries. Results In this mainly female (62%) and older (61.6 ± 11.9 years) cohort with predominately solid tumours (79%), FN risk based on chemotherapy (CT) regimen was 20% in 39% of patients. All patients with Table 1 . All patients Prophylaxis (%) Initiation (%) Duration (%) Primary Secondary 24-72 h Days 5-8 3 days 5 days Tumour type: Oncology Haematology 70 70 30 30 56 24 30 56 16 11 42 47 CT toxicity: > 20% 10-20% 76 74 56 24 26 44 53 49 54 29 32 25 13 13 15 44 39 41 Table 2 . FN risk 10-20% Prophylaxis (%) Patient-related risk factors Primary Secondary Age >65 years 79 21 Advanced disease (Stage IV) 74 26 History of prior FN 29 71 No antibiotic prophylaxis 73 24 Poor performance (ECOG >2) 83 17 Female 76 24 Hb 70 30 Liver, renal or CV disease 72 28 One or more risks 74 26 Conclusions Variability exists in biosimilar filgrastim initiation by tumour type (day of initiation), CT toxicity and patient-related risk. About a quarter of patients with FN risk >20% or 10-20% in combination with other risk factors did not receive primary prophylaxis as recommended. The trend to initiate filgrastim in regimens with Disclosure M.S. Aapro: Member of the steering committee for Sandoz Biopharmaceuticals supported study. P. Gascon: Member of the steering committee for Sandoz Biopharmaceuticals supported study. H. Ludwig: Member of the steering committee for Sandoz Biopharmaceuticals supported study. On Speakers Bureau and advisory board for Amgen. C. Bokemeyer: Member of the steering committee for Sandoz Biopharmaceuticals supported study. M. Boccadoro: Member of the steering committee for Sandoz Biopharmaceuticals supported study. M. Turner: Employee of Sandoz Biopharmaceuticals. M. Muenzberg: Employee of Sandoz Biopharmaceuticals. K. Denhaerynck: Employee of Matrix 45. I. Abraham: Employee of Matrix 45. K. Macdonald: Employee of Matrix 45.