Compatibility of Biosimilar Filgrastim with Cytotoxic Chemotherapy during the Treatment of Malignant Diseases (VENICE): A Prospective, Multicenter, Non-Interventional, Longitudinal Study.

Stefan Fruehauf,Christine Rudolph,Burkhard Otremba,Oliver Stötzer

doi:10.1007/s12325-016-0419-1

Stefan Fruehauf, Christine Rudolph + Show 2 more

Open Access

https://doi.org/10.1007/s12325-016-0419-1

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Abstract

IntroductionFebrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy. Biosimilar filgrastim (Nivestim™, Hospira Inc, A Pfizer Company, Lake Forest, IL, USA) is a granulocyte-colony stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive chemotherapy. The primary goal of this VENICE study (ClinicalTrials.gov identifier, NCT01627990) was to observe the tolerability, safety and efficacy of biosimilar filgrastim in patients receiving cancer chemotherapy.MethodsThis was a prospective, multicenter, non-interventional, longitudinal study. Consenting adult patients with solid tumors or hematologic malignancies for whom cytotoxic chemotherapy and treatment with biosimilar filgrastim was planned were enrolled.ResultsAmong the enrolled patients (N = 386), 81% were female, with a median age (range) of 61 (22–92) years, with 39% >65 years old. Most patients (n = 338; 88%) had solid tumors and the remainder (n = 49; 13%) had hematological malignancies. The majority of the patients (64%) received biosimilar filgrastim as primary prophylaxis and 36% as secondary prophylaxis. At the follow-up visits, for the majority of patients (95.6%) there had been no change in chemotherapy dose due to FN. For two patients (0.5%) the chemotherapy was discontinued due to FN and for four patients (1.0%) the chemotherapy dose was reduced due to FN. For the majority of patients (96.9%) the chemotherapy cycle following the first biosimilar filgrastim treatment was not delayed due to FN. For 3 patients (0.8%), the chemotherapy was delayed following the first biosimilar filgrastim treatment. Less than one-third (29.8%) of the patients experienced ≥1 adverse event that was at least potentially related to biosimilar filgrastim treatment.ConclusionsBiosimilar filgrastim was effective and well-tolerated in both the primary and secondary prophylactic setting in patients undergoing chemotherapy for solid tumors and hematological malignancies.Trial RegistrationClinicalTrials.gov identifier, NCT01627990.FundingHospira Inc, A Pfizer Company, Lake Forest, IL, USA.

Highlights

Febrile neutropenia (FN) is a serious and frequent complication of cytotoxic chemotherapy.Biosimilar filgrastim (NivestimTM, Hospira Inc, A Pfizer Company, Lake Forest, IL, USA) is a granulocyte-colony stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive chemotherapy
The results of three large-scale studies demonstrated that primary prophylaxis with a granulocyte-colony stimulating factor (G-CSF) significantly reduces the incidence of febrile neutropenia (FN) resulting from cytotoxic chemotherapy [4,5,6]
The ITT population included 386 adult patients undergoing cytotoxic chemotherapy who were prescribed biosimilar filgrastim to reduce the duration of neutropenia and to reduce the incidence of chemotherapy-induced FN

Summary

Introduction

Biosimilar filgrastim (NivestimTM, Hospira Inc, A Pfizer Company, Lake Forest, IL, USA) is a granulocyte-colony stimulating factor licensed for the treatment of neutropenia and FN induced by myelosuppressive chemotherapy. Neutropenia is associated with life-threatening infections and may delay the chemotherapy schedule, having a negative impact on early and long-term outcomes [2]. It is associated with significant morbidity and mortality, and may increase the overall cost of providing cancer therapy [3]. The results of three large-scale studies demonstrated that primary prophylaxis with a granulocyte-colony stimulating factor (G-CSF) significantly reduces the incidence of febrile neutropenia (FN) resulting from cytotoxic chemotherapy [4,5,6]. The use of a G-CSF plus antibiotics may reduce hospitalization time and improve the ability to achieve neutrophil recovery in individuals with chemotherapy-induced FN [8]

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