Biosimilars offer the potential to increase patient access to biological therapies and improve financial sustainability in oncology treatment.1 The filgrastim biosimilar Zarzio®/Zarxio®/EP2006 (Hexal AG) has been approved in Europe since 2009, and is prescribed according to label and guidelines for the prevention of chemotherapy-induced (CIN) and febrile neutropenia (FN) in patients receiving myelosuppressive chemotherapy. However, there is a paucity of data on the real-world use of filgrastim in non-small cell lung cancer (NSCLC). MONITOR-GCSF is an international, multicenter, prospective, observational study performed in 12 European countries. The study was designed to describe patient characteristics, treatment patterns and clinical outcomes in patients receiving biosimilar filgrastim in the prophylaxis of CIN/FN. This analysis evaluates the NSCLC cohort of the MONITOR-GCSF study.
MONITOR-GCSF enrolled 345 evaluable patients with NSCLC receiving up to 6 chemotherapy cycles. Patients were treated with biosimilar filgrastim as per their treating physician’s best judgement.
At study start patient characteristics were as follows: mean (± SD) age 62.9 (± 8.56) years; mean body weight 72.3 (±14.85) kg; 69.6% of patients were male; 29.3% of patients had stage 3 disease; and 69.9% of patients had stage 4 disease. CIN (any grade) occurred in 13.6% (n = 47) of patients in Cycle 1 and in 36.5% (n = 126) of patients in all cycles. FN occurred in 1.4% (n = 5) of patients in Cycle 1 and in 5.2% (n = 18) of patients in all cycles. Grade 3—4 FN occurred in 1.2% of patients (n = 4) in Cycle 1 and in 3.8% of patients (n = 13) in all cycles.
In real-world practice in patients with NSCLC, biosimilar filgrastim has similar efficacy and safety compared with published data on reference filgrastim. This adds to the evidence base for biosimilar filgrastim and supports its use in the NSCLC population. Reference: 1Tabernero J, et al. ESMO Open 2016;1:e000142.
Clinical trial identification
Legal entity responsible for the study
M. Aapro: Amgen (honoraria, speakers bureau, expert testimony), Helsinn Healthcare (advisory role, speakers bureau, research funding), Hospira (advisory role, speakers bureau, research funding), Teva (advisory role, speakers bureau), Merck KGaA (advisory role), Merck (advisory role), Sandoz (advisory role, speakers bureau, research funding), Pierre Fabre Medicament (advisory role, speakers bureau, research funding), Vifor Pharma (advisory role, speakers bureau), Tesaro (advisory role, speakers bureau), Novartis (speakers bureau, research funding), Roche (speakers bureau), Johnson & Johnson (speakers bureau). A. Krendyukov, N. Höbel: Hexal AG (employment). P. Gascón: Sandoz (speakers bureau).