Background: Nivestimââ??¢ (filgrastim) is a follow-on biologic agent licensed in the EU for the treatment of neutropenia\r\nand febrile neutropenia induced by myelosuppressive chemotherapy. Nivestimââ??¢ has been studied in phase 2\r\nand 3 clinical trials where its efficacy and safety was found to be similar to its reference product, NeupogenÃ?®.\r\nFollow-on biologics continue to be scrutinised for safety. We present a design for two observational phase IV\r\nstudies that are evaluating the safety profile of Nivestimââ??¢ for the prevention and treatment of febrile neutropenia\r\n(FN) in patients treated with cytotoxic chemotherapy in general clinical practice.\r\nMethods/Design: The NEXT (TolÃ?©rance de Nivestim chez les patiEnts traitÃ?©s par une chimiothÃ?©rapie anticancÃ?©reuse\r\ncytotoXique en praTique courante) and VENICE (VErtrÃ?¤glichkeit von NIvestim unter zytotoxischer Chemotherapie in\r\nder Behandlung malinger Erkrankungen) trials are multicentre, prospective, longitudinal, observational studies\r\nevaluating the safety profile of Nivestimââ??¢ in ââ?¬Ë?real-worldââ?¬â?¢ clinical practice. Inclusion criteria include patients\r\nundergoing cytotoxic chemotherapy for malignancy and receiving Nivestim as primary or secondary prophylaxis\r\n(NEXT and VENICE), or as treatment for ongoing FN (NEXT only). In accordance with European Union\r\npharmacovigilance guidelines, the primary objective is to evaluate the safety of Nivestimââ??¢ by gathering data on\r\nadverse events in all system organ classes. Secondary objectives include obtaining information on patient\r\ncharacteristics, efficacy of Nivestimââ??¢ therapy (including chemotherapy dose intensity), patterns of use of Nivestimââ??¢,\r\nand physician knowledge regarding filgrastim prescription and the reasons for choosing Nivestimââ??¢. Data will be\r\ngathered at three visits: 1. At the initial inclusion visit, 2. At a 1-month follow-up visit, and 3. At the end of\r\nchemotherapy.\r\nRecruitment for VENICE commenced in July 2011 and in November 2011 for NEXT. VENICE completed recruitment\r\nin July 2013 with 407 patients, and NEXT in September 2013 with 2123 patients. Last patient, last visit for each\r\nstudy will be December 2013 and March 2014 respectively.\r\nDiscussion: The NEXT and VENICE studies will provide long-term safety, efficacy and practice pattern data in\r\npatients receiving Nivestimââ??¢ to support myelosuppressive chemotherapy in real world clinical practice. These data\r\nwill improve our understanding of the performance of Nivestimââ??¢ in patients encountered in the general patient\r\npopulation
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