Biosimilar filgrastim vs filgrastim: a multicenter nationwide observational bioequivalence study in patients with chemotherapy-induced neutropenia

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dc.contributor.authorSevinc, Alper
dc.contributor.authorOzkan, Metin
dc.contributor.authorOzet, Ahmet
dc.contributor.authorDane, Faysal
dc.contributor.authorOksuzoglu, Berna
dc.contributor.authorIsikdogan, Abdurrahman
dc.contributor.authorOzdemir, Feyyaz
dc.date.accessioned2024-04-24T17:18:29Z
dc.date.available2024-04-24T17:18:29Z
dc.date.issued2018
dc.departmentDicle Üniversitesien_US
dc.description.abstractBackground: We studied the comparative effectiveness of biosimilar filgrastim vs original filgrastim in patients with chemotherapy-induced neutropenia. Patients and methods: This multicenter, observational study was conducted at 14 centers. The study included 337 patients experiencing neutropenia under chemotherapy. Patients were given either filgrastim 30 MIU or 48 MIU (Neupogen (R)) or biosimilar filgrastim 30 MIU (Leucostim (R)). Data regarding age, chemotherapeutic agents used, number of chemotherapy courses, previous diagnosis of neutropenia, neutrophil count of patients after treatment, medications used for the treatment of neutropenia, and duration of neutropenia were collected. Time to absolute neutrophil count (ANC) recovery was the primary efficacy measure. Results: Ambulatory and hospitalized patients comprised 11.3% and 45.1% of the enrolled patients, respectively, and a previous diagnosis of neutropenia was reported in 49.3% of the patients, as well. Neutropenia occurred in 13.7% (n=41), 45.5% (n=136), 27.4% (n=82), 11.4% (n=34), and 2.0% (n=6) of the patients during the first, second, third, fourth, and fifth cycles of chemotherapy, respectively. While the mean neutrophil count was 0.53 +/- 0.48 before treatment, a significant increase to 2.44 +/- 0.66 was observed after treatment (p=0.0001). While 90.3% of patients had a neutrophil count,1.49 before treatment, all patients had a neutrophil count >= 1.50 after treatment. Neutropenia resolved within <= 4 days of filgrastim therapy in 60.1%, 56.7%, and 52.6% of the patients receiving biosimilar filgrastim 30 MIU, original filgrastim 30 MIU, and original filgrastim 48 MIU, respectively. However, there was no significant difference between the three arms (p=0.468). Similarly, time to ANC recovery was comparable between the treatment arms (p=0.332). Conclusion: The results indicate that original filgrastim and biosimilar filgrastim have comparable efficacy in treating neutropenia. Biosimilar filgrastim provides a valuable alternative; however, there is need for further studies comparing the two products in different patient subpopulations.en_US
dc.identifier.doi10.2147/OTT.S106342
dc.identifier.endpage426en_US
dc.identifier.issn1178-6930
dc.identifier.pmid29403286
dc.identifier.scopus2-s2.0-85040948324
dc.identifier.scopusqualityQ1
dc.identifier.startpage419en_US
dc.identifier.urihttps://doi.org/10.2147/OTT.S106342
dc.identifier.urihttps://hdl.handle.net/11468/18798
dc.identifier.volume11en_US
dc.identifier.wosWOS:000422656100001
dc.identifier.wosqualityQ2
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.language.isoenen_US
dc.publisherDove Medical Press Ltden_US
dc.relation.ispartofOncotargets and Therapy
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectChemotherapyen_US
dc.subjectFebrile Neutropeniaen_US
dc.subjectNeutrophilen_US
dc.subjectAnc Recoveryen_US
dc.subjectSupportive Careen_US
dc.subjectMyelosuppressiveen_US
dc.titleBiosimilar filgrastim vs filgrastim: a multicenter nationwide observational bioequivalence study in patients with chemotherapy-induced neutropeniaen_US
dc.titleBiosimilar filgrastim vs filgrastim: a multicenter nationwide observational bioequivalence study in patients with chemotherapy-induced neutropenia
dc.typeArticleen_US

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