Safety of biosimilar filgrastim in patients undergoing neutropenia-inducing chemotherapy: Next study.

Abstract

211 Background: Febrile neutropenia (FN) is a serious, frequent complication of cytotoxic chemotherapy (CT). Biosimilar filgrastim (Nivestim, Hospira Inc.) is a granulocyte-colony stimulating factor (G-CSF) licensed for the treatment of neutropenia and FN induced by myelosuppressive CT. The NEXT (Nivestim safety profile in patients [pts] treated with cytotoxic CT in real-life clinical practice) study aimed to assess the safety of biosimilar filgrastim in pts undergoing CT for malignancies (excluding chronic myeloproliferative and myelodysplastic syndrome) and receiving biosimilar filgrastim as prophylaxis, or as curative treatment. Methods: NEXT was a prospective, non-interventional, longitudinal, multicentre study conducted in France. Recorded data included pt demographic and clinical characteristics, biosimilar filgrastim treatment-related data on efficacy and safety, such as adverse events (AEs), including FN. Pts were monitored for 1–6 CT cycles with three visits at inclusion, during treatment, and following CT. Results: Overall, 2114 pts were enrolled in the study. Of these, 2,102 pts were analysed (50.2% male). Mean age ± SD was 63.5 ± 12.7 years. 75% of pts had solid tumours and 25% had haematological malignancies. The majority (98.2%) of pts received prophylactic biosimilar filgrastim and 1.8% for curative intent. At inclusion, 92.5% of patients had no prior FN; 34.4% had prior CT; 20.2% had prior G-CSF therapy. During the study 20.4% of pts experienced ≥1 AE; AEs were reported most frequently in pts with acute leukaemia (40.0%), lymphoma (21.9%) and solid tumours (21.1%). 12.7% of pts reported bone, muscular or chest pain. 4.9% of pts experienced FN and 3.1% had an infection. Conclusions: Biosimilar filgrastim (Nivestim) was effective and well-tolerated in both the prophylactic and curative setting in pts undergoing CT for solid tumours and haematological malignancies. Biosimilar filgrastim seems to be as efficacious and as well tolerated compared with the reference filgrastim (Neupogen, Amgen) regarding retrospective data. Clinical trial information: NCT01574235.