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

BACKGROUND AND OBJECTIVES: Gilteritinib (XOSPATA®, 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 mye...

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Detalles Bibliográficos
Autores principales: Dogu, Mehmet Hilmi, Tekgunduz, Ali Irfan Emre, Deveci, Burak, Korkmaz, Gulten, Comert, Melda, Sevindik, Omur Gokmen, Yokus, Osman, Serin, Istemi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Università Cattolica del Sacro Cuore 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10171205/
https://www.ncbi.nlm.nih.gov/pubmed/37180209
http://dx.doi.org/10.4084/MJHID.2023.031
Descripción
Sumario:BACKGROUND AND OBJECTIVES: Gilteritinib (XOSPATA®, 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.