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

Didier Kamioner¹  Stefan Fruehauf⁴  Fréderic Maloisel²  Laurent Cals⁶  Stéphane Lepretre⁵  Christian Berthou³ 

[1] AFSOS and Hôpital Privé de l’Ouest Parisien, 78190 Trappes, France

[2] Clinique Saint Anne, Department of Hematology and Oncology, Strasbourg, France

[3] Département d’Clinique Hématologie, Hôpital Morvan, Brest, France

[4] Paracelsus-Klinik, Center for Tumor Diagnostics and Therapy, Osnabrück, Germany

[5] Département d’Hématologie, Centre Henri Becquerel, Rouen, France

[6] CHRU de Besançon, Besançon, France

关键词: Neutropenia;    Chemotherapy;    CD34;    Practice patterns;    Hospitalisation;    Efficacy;    Safety;    Filgrastim;    G-CSF;    Granulocyte colony-stimulating factor;   

Others  :  859251
DOI  :  10.1186/1471-2407-13-547

 received in 2012-11-05, accepted in 2013-10-29,  发布年份 2013

【 摘 要 】

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^®. 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 (Tolérance de Nivestim chez les patiEnts traités par une chimiothérapie anticancéreuse cytotoXique en praTique courante) and VENICE (VErträglichkeit 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

【 授权许可】

   
2013 Kamioner et al.; licensee BioMed Central Ltd.

【 图 表 】

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