Gilteritinib (XOSPATA®) in Turkey: Early Access Program Results

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dc.authoridSevindik, Omur Gokmen/0000-0001-9636-4113
dc.authoridSERIN, Istemi/0000-0003-1855-774X
dc.authoridComert, Melda/0000-0002-7798-4349
dc.authorwosidSevindik, Omur Gokmen/AAD-5452-2021
dc.authorwosidSERIN, Istemi/GRX-7028-2022
dc.authorwosidComert, Melda/ABH-5764-2020
dc.contributor.authorDogu, Mehmet Hilmi
dc.contributor.authorTekgunduz, Ali Irfan Emre
dc.contributor.authorDeveci, Burak
dc.contributor.authorKorkmaz, Gulten
dc.contributor.authorComert, Melda
dc.contributor.authorSevindik, Omur Gokmen
dc.contributor.authorYokus, Osman
dc.date.accessioned2024-05-19T14:41:50Z
dc.date.available2024-05-19T14:41:50Z
dc.date.issued2023
dc.departmentİstinye Üniversitesien_US
dc.description.abstractBackground And Objectives: Gilteritinib (XOSPATA (R), Astellas) is a type I oral FLT3 inhibitor, a tyrosine kinase AXL inhibitor, involved in both c-Kit and FMS-like tyrosine kinase 3 (FLT3) resistance. In the phase 3 ADMIRAL trial, gilteritinib was compared with the standard of care in (R/R) acute myeloid leukemia (AML) patients who harbored any FLT3 mutation and showed superior efficacy with regard to response and survival. Objectives: This research aimed to investigate the real-life efficacy and safety of gilteritinib in FLT3-positive R/R AML patients who were treated as a part of an early access program held in Turkey in April 2020 (NCT03409081). Results: The research included 17 R/R AML patients who had received gilteritinib from seven centers. The overall response rate was 100%. The most common adverse events were anemia and hypokalemia (7 patients, 41.2%). Grade 4 thrombocytopenia was observed in one patient only (5.9%), leading to permanent treatment discontinuation. Patients with peripheral edema had a 10.47 (95% CI: 1.64-66.82) times higher risk of death than those without peripheral edema (p<0.05). Conclusion: This research showed that patients with febrile neutropenia and peripheral edema were at a high risk of death when compared to patients without febrile neutropenia and peripheral edema.en_US
dc.identifier.doi10.4084/MJHID.2023.031
dc.identifier.issn2035-3006
dc.identifier.issue1en_US
dc.identifier.pmid37180209en_US
dc.identifier.scopus2-s2.0-85160615870en_US
dc.identifier.scopusqualityQ2en_US
dc.identifier.urihttps://doi.org10.4084/MJHID.2023.031
dc.identifier.urihttps://hdl.handle.net/20.500.12713/5167
dc.identifier.volume15en_US
dc.identifier.wosWOS:000983087400001en_US
dc.identifier.wosqualityN/Aen_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.language.isoenen_US
dc.publisherMattioli 1885en_US
dc.relation.ispartofMediterranean Journal of Hematology and Infectious Diseasesen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.snmz20240519_kaen_US
dc.subjectGilteritiniben_US
dc.subjectAcute Myeloid Leukemia (Aml)en_US
dc.subjectEarly Accessen_US
dc.subjectReal-Life Dataen_US
dc.subjectResponseen_US
dc.subjectPrognosisen_US
dc.titleGilteritinib (XOSPATA®) in Turkey: Early Access Program Resultsen_US
dc.typeArticleen_US

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