Study design: two long-term observational studies of the biosimilar filgrastim Nivestim (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia.

Article Details

Citation
Copy to clipboard

Kamioner D, Fruehauf S, Maloisel F, Cals L, Lepretre S, Berthou C

Study design: two long-term observational studies of the biosimilar filgrastim Nivestim (Hospira filgrastim) in the treatment and prevention of chemotherapy-induced neutropenia.

BMC Cancer. 2013 Nov 16;13:547. doi: 10.1186/1471-2407-13-547.

PubMed ID
24237790 [ View in PubMed
]
Abstract

BACKGROUND: Nivestim (filgrastim) is a follow-on biologic agent licensed in the EU for the treatment of neutropenia and febrile neutropenia induced by myelosuppressive chemotherapy. Nivestim has been studied in phase 2 and 3 clinical trials where its efficacy and safety was found to be similar to its reference product, Neupogen(R). Follow-on biologics continue to be scrutinised for safety. We present a design for two observational phase IV studies that are evaluating the safety profile of Nivestim for the prevention and treatment of febrile neutropenia (FN) in patients treated with cytotoxic chemotherapy in general clinical practice. METHODS/DESIGN: The NEXT (Tolerance de Nivestim chez les patiEnts traites par une chimiotherapie anticancereuse cytotoXique en praTique courante) and VENICE (VErtraglichkeit von NIvestim unter zytotoxischer Chemotherapie in der Behandlung malinger Erkrankungen) trials are multicentre, prospective, longitudinal, observational studies evaluating the safety profile of Nivestim in 'real-world' clinical practice. Inclusion criteria include patients undergoing cytotoxic chemotherapy for malignancy and receiving Nivestim as primary or secondary prophylaxis (NEXT and VENICE), or as treatment for ongoing FN (NEXT only). In accordance with European Union pharmacovigilance guidelines, the primary objective is to evaluate the safety of Nivestim by gathering data on adverse events in all system organ classes. Secondary objectives include obtaining information on patient characteristics, efficacy of Nivestim therapy (including chemotherapy dose intensity), patterns of use of Nivestim, and physician knowledge regarding filgrastim prescription and the reasons for choosing Nivestim. Data will be gathered at three visits: 1. At the initial inclusion visit, 2. At a 1-month follow-up visit, and 3. At the end of chemotherapy.Recruitment for VENICE commenced in July 2011 and in November 2011 for NEXT. VENICE completed recruitment in July 2013 with 407 patients, and NEXT in September 2013 with 2123 patients. Last patient, last visit for each study will be December 2013 and March 2014 respectively. DISCUSSION: The NEXT and VENICE studies will provide long-term safety, efficacy and practice pattern data in patients receiving Nivestim to support myelosuppressive chemotherapy in real world clinical practice. These data will improve our understanding of the performance of Nivestim in patients encountered in the general patient population. TRIAL REGISTRATION: NEXT NCT01574235, VENICE NCT01627990.

DrugBank Data that Cites this Article

Drugs